dapagliflozin profile

ID Source	ID
PubMed CID	9887712
CHEMBL ID	429910
CHEMBL ID	3125458
CHEBI ID	85078
SCHEMBL ID	157820
MeSH ID	M0522017

Synonym
HY-10450
bdbm20880
chembl429910 ,
c-aryl glucoside, 6
dapagliflozin ,
bms-512148
(2s,3r,4r,5s,6r)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol
forxiga
AKOS005145763
461432-26-8
dapagliflozin (usan/inn)
D08897
lyn-045
chebi:85078 ,
A25150
(2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol;bms-512148
EX-7214
(2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
bms 512148
1ull0qj8uc ,
unii-1ull0qj8uc
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol
d-glucitol, 1,5-anhydro-1-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-, (1s)-
(2s, 3r, 4r, 5s, 6r)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
(2s,3r,4r,5s,6r)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
(2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
JVHXJTBJCFBINQ-ADAARDCZSA-N
BCP9000583
(1s)-1,5-anhydro-1-c-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-d-glucitol
bms512148
BCPP000265
CS-0781
S1548
bdbm50448923
dapagliflozin [vandf]
dapagliflozin component of qternmet xr
qternmet xr component dapagliflozin
dapagliflozin [mi]
dapagliflozin [inn]
dapagliflozin component qternmet
dapagliflozin [orange book]
(2s,3r,4r,5s,6r)-2-[4-chloro-3-(4-ethoxybenzyl)phenyl]-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
dapagliflozin [who-dd]
qternmet component dapaglifozin
dapagliflozin [usan]
gtpl4594
DB06292
SCHEMBL157820
CHEMBL3125458 ,
J-500392
(2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol
s1548_selleck
(1s)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-d-glucitol
AC-24699
CCG-229917
mfcd13182359
bms5121458
EX-A005
(1s)-1,5-anhydro-1-c-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-d-glucitol; (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol; (2s,3r,4r,5s,6r)-2-[4-chloro-3-(4-ethoxybenzyl)phenyl]-6-(hydroxymethyl)t
DTXSID20905104 ,
Q409898
BD164346
AMY18541
BRD-K58160573-001-01-3
BRD-K58160573-001-05-4
BL-0052
C22193
NCGC00250402-09
dagagflozin
(2s,3r,4r,5s,6r)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
EN300-7407160
dapagliflozinum
dapagliflozina
a10bk01
dtxcid101334207
dapagliflozine
(1s)-1,5-anhydro-1-(4-chloro-3-(4-ethoxybenzyl)phenyl)-d-glucitol
Z2235801883

Excerpt	Reference	Relevance
"Dapagliflozin (DAPA) is a selective sodium-glucose cotransporter-2 inhibitor that reduces renal glucose reabsorption. "	( Multi-Spectroscopic, thermodynamic and molecular dynamic simulation studies for investigation of interaction of dapagliflozin with bovine serum albumin. Abdelaziz, MA; Belal, F; El-Domany, RA; Shaldam, M, 2022)	2.38
"Dapagliflozin is an inhibitor of human renal sodium-glucose cotransporter 2 (SGLT2), first approved for the treatment of type 2 diabetes mellitus (T2DM). "	( Common UGT1A9 polymorphisms do not have a clinically meaningful impact on the apparent oral clearance of dapagliflozin in type 2 diabetes mellitus. Boulton, DW; Chang, R; Naagaard, MD; Någård, M; Tang, W, 2022)	2.38
"Dapagliflozin is an oral agent for type 2 diabetes mellitus (T2DM) belonging to the sodium/glucose cotransporter 2 inhibitor (SGLT2-I) class of antihyperglycemic medications. "	( An update on dapagliflozin for chronic kidney disease. Kelly, MS, 2022)	2.53
"Dapagliflozin was found to be a highly cost-effective and cost-saving medication when compared to SOC and sacubitril/valsartan, respectively, in the treatment of HF-rEF from Egyptian healthcare system perspective. "	( Dapagliflozin cost-effectiveness analysis in heart failure patients in Egypt. Abdelhamid, M; Elsisi, GH; Emad, S; Kirollos, M; Mansy, S; Seyam, A; Shafie, A; Sobhy, M, )	3.02
"Dapagliflozin is a sodium glucose cotransporter-II inhibitor while saxagliptin is a dipeptidyl peptidase-4 inhibitor. "	( Univariate and Multivariate Determination of Dapagliflozin and Saxagliptin in Bulk and Dosage Form. Elhassan, MM; Hegazy, MA; Mahmoud, AM; Mowaka, S, 2023)	2.61
"Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor approved to treat type 2 diabetes mellitus (T2DM), among other conditions. "	( Post-Authorization Safety Study of Hospitalization for Acute Kidney Injury in Patients with Type 2 Diabetes Exposed to Dapagliflozin in a Real-World Setting. Arana, A; Beachler, DC; Calingaert, B; Chen, H; Danysh, HE; Dinh, J; Gilsenan, A; Hunt, PR; Johannes, CB; Johnsson, K; Karlsson, C; Layton, JB; Li, L; Pladevall-Vila, M; Ziemiecki, R, 2023)	2.56
"Dapagliflozin is an agent that has both antihyperglycemic effects and is significantly associated with a lower risk of cardiovascular events in patients with diabetes mellitus (DM). "	( The effect of dapagliflozin therapy on ventricular repolarization parameters in electrocardiography in patients with diabetic cardiovascular disease. Açıkel, B; Ömür, SE; Zorlu, Ç, 2023)	2.71
"Dapagliflozin is an inhibitor of sodium‑glucose cotransporter 2 that has an important protective effect on the kidney."	( Dapagliflozin alleviates renal podocyte pyroptosis via regulation of the HO‑1/NLRP3 axis. Liu, C; Ni, P; Song, Y; Tang, M; Zhang, Z; Zhao, B, 2023)	3.07
"Dapagliflozin (DAPA) is a sodium-glucose-linked transporter 2 (SGLT-2) inhibitor that has been shown to improve cardiac function in non-diabetic patients with heart failure (HF)."	( SIRT1 mediates the inhibitory effect of Dapagliflozin on EndMT by inhibiting the acetylation of endothelium Notch1. Li, S; Li, Y; Wang, K; Wang, W; Ye, T; Zhang, Y, 2023)	1.9
"Dapagliﬂozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor; it reduces glucose reabsorption via the kidney and increases the glucose excretion in urine. "	( Effect of dapagliflozin alone and in combination with insulin in a rat model of type 1 diabetes. Abdalla, O; Dessouki, A; Kilany, O; Sasaki, K; Sayed, N; Shimoda, M; Yoshida, T, 2020)	0.96
"Dapagliflozin is a sodium-glucose co-transporter 2 inhibitor that has been developed as oral glucose lowering drug. "	( Exposure-response relationships of dapagliflozin on cardiorenal risk markers and adverse events: A pooled analysis of 13 phase II/III trials. Heerspink, HJL; Koomen, JV; Stevens, J, 2020)	2.28
"Dapagliflozin (DPG) is a novel drug from class of sodium glucose co-transporter 2 (SGL-2) inhibitors which has been evolved as profound treatment option for the type-2diabetes mellitus (T2DM). "	( Pharmaceutical Analytical Profile for Novel SGL-2 Inhibitor: Dapagliflozin. Bobade, PS; Dhote, AM; Ganorkar, SB; Patil, MR; Sharma, SS; Shirkhedkar, AA, 2021)	2.31
"Dapagliflozin is a cost-saving alternative to DPP-4 inhibitors when added to metformin and sulfonylurea. "	( The cost-effectiveness of dapagliflozin compared to DPP-4 inhibitors in the treatment of type 2 diabetes mellitus in the Netherlands. Nekeman, S; Uyl-de Groot, CA; Van der Linden, N; Van Olst, S, 2021)	2.36
"Dapagliflozin is likely to be a cost-effective treatment for HFrEF in the UK, German and Spanish healthcare systems."	( Cost-effectiveness of dapagliflozin as a treatment for heart failure with reduced ejection fraction: a multinational health-economic analysis of DAPA-HF. Bergenheim, K; Böhm, M; Darlington, O; Docherty, KF; Jhund, PS; McEwan, P; McMurray, JJV; Petrie, MC; Qin, L, 2020)	2.32
"Dapagliflozin is an antidiabetic medication that has been shown to reduce the risk of heart failure hospitalization and cardiovascular death in patients with heart failure with reduced ejection fraction (HFrEF). "	( Cost-utility analysis of add-on dapagliflozin treatment in heart failure with reduced ejection fraction. Krittayaphong, R; Permsuwan, U, 2021)	2.35
"Dapagliflozin is a cost-effective add-on therapy for patients with HFrEF at a WTP of 160,000 THB/QALY (5131 USD/QALY)."	( Cost-utility analysis of add-on dapagliflozin treatment in heart failure with reduced ejection fraction. Krittayaphong, R; Permsuwan, U, 2021)	2.35
"Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor which is commonly used for type-2 diabetes mellitus management."	( Effect of dapagliflozin and/or L-arginine on solid tumor model in mice: The interaction between nitric oxide, transforming growth factor-beta 1, autophagy, and apoptosis. Abd Elmaaboud, MA; Arab, HH; Kabel, AM, 2021)	1.75
"Dapagliflozin (DAP) is a potent and selective sodium-glucose contransporter-2 inhibitor, for treating type 2 diabetes. "	( Dapagliflozin-citric acid cocrystal showing better solid state properties than dapagliflozin. Chen, JM; Deng, JH; Lu, TB; Sun, CC, 2017)	3.34
"Dapagliflozin is a selective sodium-glucose cotransporter 2 inhibitor that improves glycemic control in patients with type II diabetes mellitus (T2DM) by reducing renal glucose reabsorption."	( Dapagliflozin in patients with type II diabetes mellitus, with and without elevated triglyceride and reduced high-density lipoprotein cholesterol levels. Bays, HE; Sartipy, P; Sjöström, CD; Underberg, JA; Xu, J, )	3.02
"Dapagliflozin is a member of a unique class of anti-diabetic drugs that inhibit the sodium-glucose cotransporter 2 (SGLT-2) in the renal tubules and have an insulin-independent mechanism of action."	( Durability of response to dapagliflozin: a review of long-term efficacy and safety. Jabbour, S, 2017)	1.48
"Dapagliflozin is a sodium-glucose co-transporter-2 (SGLT-2) inhibitor that reduces blood glucose in patients with type 2 diabetes mellitus (T2DM) by promoting glycosuria via inhibiting urinary glucose reabsorption. "	( The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Trial. Bansilal, S; Bhatt, DL; Bonaca, MP; Cahn, A; Gause-Nilsson, IA; Johansson, PA; Kato, ET; Langkilde, AM; Leiter, LA; McGuire, DK; Mosenzon, O; Raz, I; Sabatine, MS; Silverman, MG; Wilding, JP; Wiviott, SD, 2018)	2.2
"Dapagliflozin (DAPA) is an inhibitor of sodium-glucose cotransporter 2 prescribed for type 2 diabetes mellitus. "	( Dapagliflozin Attenuates Cardiac Remodeling in Mice Model of Cardiac Pressure Overload. Jiang, A; Li, F; Shi, L; Wang, S; Zhu, D, 2019)	3.4
"Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor that improves glycemic control in patients with type II diabetes mellitus which increasing urinary glucose excretion. "	( Lipid profile in type 2 diabetic patients with new dapagliflozin treatment; actual clinical experience data of six months retrospective lipid profile from single center. Calapkulu, M; Cander, S; Ersoy, C; Gul, OO, )	1.83
"Dapagliflozin is a selective, competitive inhibitor of sodium/glucose cotransporter 2 (SGLT2) acting to block reabsorption of filtered glucose in the kidney. "	( Dapagliflozin, an SGLT2 inhibitor for the treatment of type 2 diabetes. Demaris, KM; White, JR, 2013)	3.28
"Dapagliflozin is an investigative SGLT2 inhibitor with demonstrated glycemic benefits in patients with diabetes."	( Urinary tract infections in patients with diabetes treated with dapagliflozin. Johnsson, KM; List, JF; Parikh, SJ; Ptaszynska, A; Schmitz, B; Sugg, J, )	1.09
"Dapagliflozin is an orally active, highly selective SGLT2 inhibitor that improves glycemic control in patients with type 2 diabetes mellitus (T2DM) by reducing renal glucose reabsorption leading to urinary glucose excretion (glucuresis)."	( Clinical pharmacokinetics and pharmacodynamics of dapagliflozin, a selective inhibitor of sodium-glucose co-transporter type 2. Boulton, DW; Griffen, SC; Kasichayanula, S; Lacreta, F; Liu, X, 2014)	1.38
"Dapagliflozin is a novel treatment choice for type 2 diabetes."	( Dapagliflozin treatment for type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. An, Z; Li, S; Song, H; Wu, B; Zhang, L; Zhang, M, 2014)	2.57
"Dapagliflozin appears to be an effective treatment for type 2 diabetes, although it may increase the risk of urinary tract infections and genital tract infections."	( Dapagliflozin treatment for type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. An, Z; Li, S; Song, H; Wu, B; Zhang, L; Zhang, M, 2014)	3.29
"Dapagliflozin is a first-in-class oral sodium glucose co-transporter 2 (SGLT2) inhibitor. "	( The efficacy of dapagliflozin combined with hypoglycemic drugs in treating type 2 diabetes: protocol for meta-analysis of randomized controlled trials. Che, WS; Chen, X; Leung, SW; Sun, YN; Zhou, Y, 2013)	2.18
"Dapagliflozin is a highly selective, orally active inhibitor of renal sodium-glucose cotransporter 2 that reduces hyperglycemia by increasing urinary glucose excretion. "	( Dapagliflozin as monotherapy in drug-naive Asian patients with type 2 diabetes mellitus: a randomized, blinded, prospective phase III study. Iqbal, N; Ji, L; Li, H; List, JF; Ma, J; Mansfield, TA; Ptaszynska, A; T'joen, CL, 2014)	3.29
"Dapagliflozin is a selective inhibitor of SGLT2."	( Dapagliflozin: glucuretic action and beyond. Balakumar, P; Dhanaraj, SA; Sundram, K, 2014)	2.57
"Dapagliflozin treatment is a cost-effective treatment alternative for Type 2 diabetes in all four Nordic countries."	( Cost-effectiveness of dapagliflozin (Forxiga®) added to metformin compared with sulfonylurea added to metformin in type 2 diabetes in the Nordic countries. Bergenheim, K; Ekman, M; Granström, O; McEwan, P; Sabale, U, 2015)	1.45
"Dapagliflozin is a new antidiabetic agent that belongs to the class of sodium glucose transporter 2 (SGLT-2) inhibitors. "	( Dapagliflozin therapy in type-2 diabetes: current knowledge and future perspectives. Al-Busaidi, N; Rizvi, AA; Rizzo, M, 2015)	3.3
"Dapagliflozin is a useful therapy for adult patients with T2D. "	( Dapagliflozin for the treatment of type 2 diabetes: a review of the literature. Narendran, P; Saeed, MA, 2014)	3.29
"Dapagliflozin is a highly selective and reversible SGLT2 inhibitor approved for use in adult patients with T2DM as monotherapy in patients intolerant of metformin or as adjunctive therapy in patients inadequately controlled on existing antidiabetic medications, including insulin."	( Efficacy and safety of dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in diabetes mellitus. Fioretto, P; Giaccari, A; Sesti, G, 2015)	1.45
"Dapagliflozin is a SGLT2 (Sodium/Glucose cotransporter 2) inhibitor that reduces circulating glucose levels in type 2 diabetic patients by blocking the SGLT2-dependent reabsorption of glucose in the kidney. "	( Effect of dapagliflozin on colon cancer cell [Rapid Communication]. Okada, J; Okada, S; Osaki, A; Saito, T; Shibusawa, R; Shimoda, Y; Tagaya, Y; Yamada, E; Yamada, M, 2015)	2.26
"Dapagliflozin (DAPA) is a selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2) which induces glucosuria and osmotic diuresis. "	( Inhibition of Sodium-Glucose Cotransporter 2 with Dapagliflozin in Han: SPRD Rats with Polycystic Kidney Disease. Edenhofer, I; Kapoor, S; Kipar, A; Mei, C; Riwanto, M; Rodriguez, D; Segerer, S; Wüthrich, RP; Yang, M, 2015)	2.11
"Dapagliflozin is an inhibitor of the human sodium-glucose co-transporter 2 (SGLT2) that has been shown to improve glycaemic control in patients with type 2 diabetes mellitus (T2DM). "	( Early drug use of dapagliflozin prescribed by general practitioners and diabetologists in Germany. Hammar, N; Hankins, M; Kim, J; Tsai, K, 2017)	2.23
"Dapagliflozin is a sodium-glucose co-transporter 2 inhibitor that reduces hyperglycemia by inducing significant amounts of glucosuria."	( Dapagliflozin: where does it fit in the treatment of type 2 diabetes? Woo, VC, 2009)	2.52
"Dapagliflozin was not found to be an inhibitor or an inducer of human P450 enzymes."	( In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans. Discenza, L; Ellsworth, BA; Humphreys, WG; Kasichayanula, S; Khanna, A; Komoroski, B; Koplowitz, B; Li, W; Meng, W; Obermeier, M; Washburn, W; Whaley, JM; Yao, M; Zhu, M, 2010)	1.34
"Dapagliflozin is a stable, competitive, reversible, and highly selective inhibitor of sodium-glucose co-transporter 2, the major transporter responsible for renal glucose reabsorption. "	( Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: effects on glycaemic control and body weight. Feng, Y; Kasichayanula, S; List, J; Pfister, M; Zhang, L, 2010)	3.25
"Dapagliflozin is an inhibitor of sodium-glucose co-transporter 2 (SGLT-2) in development for the treatment of Type 2 diabetes. "	( Validated LC-MS/MS methods for the determination of dapagliflozin, a sodium-glucose co-transporter 2 inhibitor in normal and ZDF rat plasma. Arnold, M; Aubry, AF; Cai, J; Couerbe, P; Deng, Y; Gu, H; Magnier, R; Morgan, L; Tirmenstein, M; Wang, B; Xu, X, 2010)	2.05
"Dapagliflozin is a potent and selective inhibitor of sodium-glucose co-transporter type 2 that is being developed for the treatment of type 2 diabetes mellitus. "	( Effect of a high-fat meal on the pharmacokinetics of dapagliflozin, a selective SGLT2 inhibitor, in healthy subjects. Aubry, AF; Boulton, DW; Kasichayanula, S; LaCreta, FP; Liu, X; Pfister, M; Reele, SB; Zhang, W, 2011)	2.06
"Dapagliflozin is a highly selective sodium-glucose co-transporter 2 inhibitor developed for the treatment of Type 2 diabetes mellitus. "	( Development of the sodium-glucose co-transporter 2 inhibitor dapagliflozin for the treatment of patients with type 2 diabetes mellitus. Bastien, A; Gerich, JE, 2011)	2.05
"Dapagliflozin is a potent and selective sodium glucose cotransporter-2 (SGLT2) inhibitor which promotes urinary glucose excretion and induces weight loss. "	( Weight loss induced by chronic dapagliflozin treatment is attenuated by compensatory hyperphagia in diet-induced obese (DIO) rats. Cullen, MJ; Devenny, JJ; Godonis, HE; Harvey, SJ; Pelleymounter, MA; Rooney, S, 2012)	2.11
"Dapagliflozin is a novel oral antihyperglycemic agent that has demonstrated promise as monotherapy and as synergistic combination therapy with currently available agents in Phase 3 clinical trials. "	( Dapagliflozin for the treatment of type 2 diabetes. Anderson, SL; Marrs, JC, 2012)	3.26
"Dapagliflozin is a potent, selective, and reversible inhibitor of SGLT2 that lowers blood glucose levels in an insulin-independent fashion."	( Targeting renal glucose reabsorption for the treatment of type 2 diabetes mellitus using the SGLT2 inhibitor dapagliflozin. Boulton, DW; Jabbour, SA; List, JF; Parikh, S; Poucher, SM; Reilly, TP; Saye, J; Tirmenstein, M; Whaley, JM, 2012)	1.31
"Dapagliflozin is a selective sodium glucose cotransporter 2 (SGLT2) inhibitor that decreases serum glucose by reducing renal glucose reabsorption, thereby promoting urinary glucose excretion. "	( Effects of rifampin and mefenamic acid on the pharmacokinetics and pharmacodynamics of dapagliflozin. Boulton, DW; Griffen, SC; Kasichayanula, S; Lacreta, FP; Liu, X, 2013)	2.06
"Dapagliflozin is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor under development as a treatment for type 2 diabetes mellitus (T2DM). "	( Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control: a phase II multicentre, randomized, double-blind, placebo-controlled trial. Azuma, H; Hayashi, N; Inoue, S; Kaku, K; Kiyosue, A; Langkilde, AM; Matsuoka, O; Parikh, S; Tokudome, T, 2013)	2.14

Excerpt	Reference	Relevance
"Dapagliflozin has a definite curative effect in heart failure patients with type 2 diabetes mellitus, which can effectively reduce the inflammatory response of patients and inhibit the myocardial fibrosis, and has a potential value in improving cardiac function and promoting prognosis."	( Effect of Dapagliflozin on Indicators of Myocardial Fibrosis and Levels of Inflammatory Factors in Heart Failure Patients. Chen, K; Liu, J; Qin, S; Qin, Y; Wang, C; Wu, X; Xiao, W; Yang, Y; Zhang, X, 2022)	2.57
"Dapagliflozin has a borderline significant effect on IRAPe but not IL-34, and Glimepiride has significant effect on IL-34 but not IRAPe."	( Comparative study of Dapagliflozin versus Glimepiride effect on insulin regulated aminopeptidase (IRAP) and interleukin-34 (IL-34) in patient with type 2 diabetes mellitus. El-Gharbawy, NM; Omran, GA; Werida, RH; Zekry, R, 2023)	1.95
"Dapagliflozin has a favourable and predictable tolerability profile, with reported events related to its mechanism of action."	( Safety profile of dapagliflozin for type 2 diabetes: pooled analysis of clinical studies for overall safety and rare events. Apanovitch, AM; de Bruin, TW; Johnsson, KM; List, JF; Parikh, SJ; Ptaszynska, A, 2014)	2.18
"Dapagliflozin has a low risk of hypoglycaemia, although the incidence varies depending on background therapy, and genital mycotic infections (particularly in women) are the most common adverse events."	( Dapagliflozin: a review of its use in patients with type 2 diabetes. Plosker, GL, 2014)	2.57
"Dapagliflozin has a favorable safety profile, with the rates of hypoglycemia similar to those of placebo."	( Dapagliflozin: a novel sodium-glucose cotransporter type 2 inhibitor for the treatment of type 2 diabetes mellitus. Choksi, R; Deeb, WE; Epstein, BJ; Shah, NK, 2012)	2.54
"Dapagliflozin has a low propensity to cause hypoglycaemia, especially when used alone or in combination with metformin, although the incidence of hypoglycaemic events reported with dapagliflozin in clinical trials varied depending on the background therapy."	( Dapagliflozin: a review of its use in type 2 diabetes mellitus. Plosker, GL, 2012)	2.54
"Dapagliflozin has been studied in a wide range of patients with diabetes and plethora of evidence has confirmed its efficacy as a monotherapy as well as an add-on to the oral therapies and insulin, when compared to placebo."	( Current Role of Dapagliflozin in Clinical Practice. Aiwale, A; Ghag, S; Pawar, R; Trailokya, AA; Zalke, A; Zargar, AH, 2021)	1.69
"Dapagliflozin (DAPA) has been reported to have significant cardiac protective effects on heart failure (HF). "	( Appropriate Dose of Dapagliflozin Improves Cardiac Outcomes by Normalizing Mitochondrial Fission and Reducing Cardiomyocyte Apoptosis After Acute Myocardial Infarction. Chen, X; Fan, ZG; Ji, MY; Ma, GS; Xu, Y, 2022)	2.49
"Dapagliflozin has been demonstrated to improve glycemic control, blood pressure, and body weight in type 2 diabetes mellitus (T2D); indeed, it can also reduce the risk of progression to renal failure, of hospitalization for heart failure and of cardiovascular death. "	( Dapagliflozin acutely improves kidney function in type 2 diabetes mellitus. The PRECARE study. Bellante, R; Berra, C; Bolla, A; Chebat, E; Cimino, V; D'Addio, F; Desenzani, P; Fiorina, P; Folli, F; Franzetti, I; Gandolfi, A; Gazzaruso, C; Genovese, S; Ghelardi, R; Girelli, A; Lazzaroni, E; Loretelli, C; Lunati, ME; Manfrini, R; Montefusco, L; Morpurgo, PS; Muratori, F; Muratori, M; Nasr, MB; Orsi, E; Pastore, I; Plebani, L; Rossi, A; Scaranna, C; Tinari, C; Vallone, L, 2022)	3.61
"Dapagliflozin has been shown to improve overall health status based on aggregate summary scores of the Kansas City Cardiomyopathy Questionnaire (KCCQ) in patients with heart failure (HF) with mildly reduced or preserved ejection fraction enrolled in the Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure (DELIVER) trial. "	( Association of Dapagliflozin vs Placebo With Individual Kansas City Cardiomyopathy Questionnaire Components in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the DELIVER Trial. Belohlávek, J; Bengtsson, O; Borleffs, CJW; Chandra, A; Claggett, BL; de Boer, RA; Desai, AS; Dobreanu, D; Hernandez, AF; Inzucchi, SE; Janssens, SP; Jhund, PS; Kosiborod, MN; Lam, CSP; Langkilde, AM; Martinez, FA; McMurray, JJV; Peikert, A; Petersson, M; Shah, SJ; Solomon, SD; Vaduganathan, M, 2023)	2.71
"Dapagliflozin has been proposed as a potential treatment for coronavirus disease 2019 (COVID-19) by reducing cytokine production and inflammation. "	( Effect of dapagliflozin on COVID-19 infection and risk of hospitalization. Cordero, A; Eiras, S; Figueiras, A; Gonzalez-Juanatey, JR; Piñeiro-Lamas, M; Rodriguez-Mañero, M; Salgado-Barreira, A; Seijas-Amigo, J, 2023)	2.76
"Dapagliflozin has been widely used for the treatment of type 2 diabetes mellitus (T2DM) and heart failure (HF). "	( Rationale and design of a randomized trial of the dapagliflozin evaluation on atrial fibrillation patients followed Cox-Maze IV: the DETAIL-CMIV study. Hua, K; Osmanaj, F; Peng, Z; Yang, X; Yang, Y, 2023)	2.61
"Dapagliflozin has shown non-inferiority compared with pioglitazone for glycemic control, and superiority regarding weight reduction in patients with type 2 diabetes."	( Favorable effect of sodium-glucose cotransporter 2 inhibitor, dapagliflozin, on non-alcoholic fatty liver disease compared with pioglitazone. Aoki, S; Atsumi, T; Cho, KY; Kameda, H; Kurihara, Y; Miya, A; Miyoshi, H; Nakamura, A; Nomoto, H; Omori, K; Takase, T; Taneda, S; Yamamoto, K, 2021)	1.58
"Dapagliflozin has been shown to reduce the risk of cardiovascular death or worsening heart failure (HF) in patients with chronic HF and reduced ejection fraction (HFrEF). "	( Time to Clinical Benefit of Dapagliflozin and Significance of Prior Heart Failure Hospitalization in Patients With Heart Failure With Reduced Ejection Fraction. Bengtsson, O; Berg, DD; Docherty, KF; Inzucchi, SE; Jhund, PS; Kosiborod, MN; Køber, L; Langkilde, AM; Martinez, FA; McMurray, JJV; Murphy, SA; Ponikowski, P; Sabatine, MS; Sjöstrand, M; Solomon, SD; Verma, S, 2021)	2.36
"Dapagliflozin has been approved for the treatment of type 2 diabetes in the European Union; however, the United States Food and Drug Administration rejected the approval of dapagliflozin based on lack of clinical data to effectively assess the benefit-to-risk profile."	( Dapagliflozin, an SGLT2 inhibitor for the treatment of type 2 diabetes. Demaris, KM; White, JR, 2013)	2.55
"Dapagliflozin therapy has been shown to impact a number of CV risk factors."	( Effects of dapagliflozin on cardiovascular risk factors. Hardy, E; Johnsson, E; List, J; Parikh, S; Ptaszynska, A, 2013)	1.5
"Dapagliflozin has been shown to be effective and safe in patients with type-2 diabetes, with modest but significant reductions in HbA1c and a number of potentially beneficial and sustained non-glycemic effects, including those on body weight, plasma lipids and systolic blood pressure."	( Dapagliflozin therapy in type-2 diabetes: current knowledge and future perspectives. Al-Busaidi, N; Rizvi, AA; Rizzo, M, 2015)	2.58
"Dapagliflozin has been shown to improve glycemic parameters in patients with type 2 diabetes when used as monotherapy or in combination with metformin, glimepiride, pioglitazone, sitagliptin, or insulin."	( Dapagliflozin: a new sodium-glucose cotransporter 2 inhibitor for treatment of type 2 diabetes. Vivian, EM, 2015)	2.58

Excerpt	Reference	Relevance
"Dapagliflozin appeared to increase iron use but improved outcomes, irrespective of iron status at baseline."	( Iron Deficiency in Heart Failure and Effect of Dapagliflozin: Findings From DAPA-HF. Bengtsson, O; De Boer, RA; Docherty, KF; Hammarstedt, A; Jhund, PS; Kosiborod, MN; Køber, L; Langkilde, AM; Lindholm, D; Little, DJ; Martinez, FA; McMurray, JJV; Morrow, DA; O'Meara, E; Ponikowski, P; Sabatine, MS; Sattar, N; Schou, M; Sjöstrand, M; Solomon, SD; Verma, S; Welsh, P, 2022)	1.7
"Dapagliflozin + ramipril generate better QALYs and lower costs than ramipril in CKD patients."	( Projecting the potential cost-effectiveness of dapagliflozin for chronic kidney disease in Kuwait. Aljazzar, M; Elsisi, GH; Ibrahim, MM; Swidan, A; Tawfik Sallam, H, )	1.11
"Dapagliflozin (DAPA) can inhibit cell pyroptosis to improve atherosclerosis."	( Dapagliflozin Attenuates NLRP3/Caspase-1 Signaling Pathway-Mediated Pyroptosis of Vascular Smooth Muscle Cells by Downregulating CTSB. Gong, C; Li, H; Liu, D; Zhao, G; Zhao, Q; Zhou, B, 2023)	3.07
"Dapagliflozin promotes glucosuria by inhibiting the renal sodium-glucose cotransporter-2 transporter."	( Use of low-dose clinical pharmacodynamic and pharmacokinetic data to establish an occupational exposure limit for dapagliflozin, a potent inhibitor of the renal sodium glucose co-transporter 2. Boulton, DW; Gould, JC; Kasichayanula, S; Shepperly, DC, 2013)	1.32
"Dapagliflozin did not increase the risk of fractures (<65 years: 1.1 vs."	( Long-Term Safety of Dapagliflozin in Older Patients with Type 2 Diabetes Mellitus: A Pooled Analysis of Phase IIb/III Studies. Fioretto, P; Johnsson, E; Mansfield, TA; Parikh, S; Ptaszynska, A; Yavin, Y, 2016)	1.48

Excerpt	Reference	Relevance
"Dapagliflozin treatment improved insulin resistance by decreasing glucose and insulin levels, increased serum magnesium levels, and reduced urinary magnesium excretion."	( Effect of Dapagliflozin and Magnesium Supplementation on Renal Magnesium Handling and Magnesium Homeostasis in Metabolic Syndrome. Kuo, WH; Lee, CT; Lee, WC; Leung, FF; Ng, HY; Tain, YL, 2021)	1.75
"Dapagliflozin treatment decreased liver weight, liver enzymes, together with marked improvement in histopathological changes."	( Dapagliflozin improves steatohepatitis in diabetic rats via inhibition of oxidative stress and inflammation. Ali, DA; Hazem, RM; Ibrahim, AZ; Moustafa, YM, 2022)	2.89
"Dapagliflozin treatment causes a reduction in BM mainly by reducing fat mass. "	( Metabolic changes induced by dapagliflozin, an SGLT2 inhibitor, in Japanese patients with type 2 diabetes treated by oral anti-diabetic agents: A randomized, clinical trial. Arima, H; Fujita, Y; Horibe, K; Ida, S; Itoh, R; Kondo, K; Maegawa, H; Miura, K; Miyazawa, I; Morino, K; Murata, K; Ohashi, N; Sato, D; Tanaka-Mizuno, S; Ugi, S; Yanagimachi, T; Yoshimura, M, 2022)	2.46
"Dapagliflozin as a treatment option in patients with nonalcoholic fatty liver disease (NAFLD) has received increasing attention, however, the efficacy and safety of dapagliflozin for NAFLD has not been well assessed. "	( Effects of dapagliflozin in patients with nonalcoholic fatty liver disease: A systematic review and meta-analysis of randomized controlled trials. Deng, C; Gu, Y; He, Y; Shi, J; Sun, L; Yang, L, 2022)	2.55
"The dapagliflozin treatment improved the ERG b-wave amplitude and decreased acellular capillary numbers. "	( Dapagliflozin protects neural and vascular dysfunction of the retina in diabetes. Bello, E; Bhatwadekar, AD; Dhami, H; Leley, SP; Luo, Q; Mathew, D, 2022)	2.72
"Dapagliflozin treatment decreased collagen type I and hyaluronic acid levels in mice; additionally, it affected the transforming growth factor (TGF)-β/hyaluronan synthase pathway, further reducing hyaluronic acid levels."	( Skin Dryness Induced in the KK-Ay/TaJcl Type 2 Diabetes Mouse Model Deteriorates Following Dapagliflozin Administration. Hiramoto, K; Horikawa, T; Ooi, K; Tanaka, S, 2022)	1.66
"Dapagliflozin treatment increased intramyocellular lipid content (0.060 (0.011, 0.110) %, p = 0.019)."	( Effects of SGLT2 inhibitor dapagliflozin in patients with type 2 diabetes on skeletal muscle cellular metabolism. Dautzenberg, B; de Ligt, M; Esterline, R; Gemmink, A; Havekes, B; Hesselink, MKC; Hoeks, J; Jorgensen, JA; Kersten, S; Kornips, E; Koves, TR; Muoio, DM; Op den Kamp, YJM; Oscarsson, J; Pava, DA; Phielix, E; Schaart, G; Schrauwen, P; Schrauwen-Hinderling, VB, 2022)	1.74
"Dapagliflozin treatment for 5 weeks leads to adaptive changes in skeletal muscle substrate metabolism favoring metabolism of fatty acid and ketone bodies and reduced glycolytic flux. "	( Effects of SGLT2 inhibitor dapagliflozin in patients with type 2 diabetes on skeletal muscle cellular metabolism. Dautzenberg, B; de Ligt, M; Esterline, R; Gemmink, A; Havekes, B; Hesselink, MKC; Hoeks, J; Jorgensen, JA; Kersten, S; Kornips, E; Koves, TR; Muoio, DM; Op den Kamp, YJM; Oscarsson, J; Pava, DA; Phielix, E; Schaart, G; Schrauwen, P; Schrauwen-Hinderling, VB, 2022)	2.46
"Dapagliflozin treatment resulted in a urinary glucose excretion of 36 g/24-h, leading to a negative energy and fat balance. "	( Effects of the sodium-glucose cotransporter 2 inhibitor dapagliflozin on substrate metabolism in prediabetic insulin resistant individuals: A randomized, double-blind crossover trial. Andriessen, C; de Ligt, M; Erazo-Tapia, E; Esterline, R; Havekes, B; Jörgensen, JA; Mevenkamp, J; Moonen-Kornips, E; Op den Kamp, Y; Oscarsson, J; Phielix, E; Schaart, G; Schrauwen, P; Schrauwen-Hinderling, VB; Veelen, A, 2023)	2.6
"Dapagliflozin treatment of prediabetic insulin resistant individuals for 14 days resulted in significant metabolic adaptations in whole-body and skeletal muscle substrate metabolism despite being weight neutral. "	( Effects of the sodium-glucose cotransporter 2 inhibitor dapagliflozin on substrate metabolism in prediabetic insulin resistant individuals: A randomized, double-blind crossover trial. Andriessen, C; de Ligt, M; Erazo-Tapia, E; Esterline, R; Havekes, B; Jörgensen, JA; Mevenkamp, J; Moonen-Kornips, E; Op den Kamp, Y; Oscarsson, J; Phielix, E; Schaart, G; Schrauwen, P; Schrauwen-Hinderling, VB; Veelen, A, 2023)	2.6
"Dapagliflozin treated DR mice exhibited metabolic benefits reflected by healthy body weight gain and pronounced glucose tolerance. "	( Determining the Role of SGLT2 Inhibition with Dapagliflozin in the Development of Diabetic Retinopathy. Herat, LY; Matthews, JR; Matthews, VB; Ong, WE; Rakoczy, EP; Schlaich, MP, 2022)	2.42
"Dapagliflozin, a new treatment option for heart failure, leads to a significant reduction in the hospitalization of patients with heart failure. "	( Cost Effectiveness of Adding Dapagliflozin to Standard Care in Heart Failure Patients with Reduced Ejection Fraction: A Systematic Review. Barzegar, M; Gorji, HA; Haghjoo, M; Rezapour, A; Sheikhy-Chaman, M; Souresrafil, A; Tashakori-Miyanroudi, M; Tatarpour, P; Yousefzadeh, N, 2023)	2.64
"Dapagliflozin treatment activated AMPK signaling, decreased the level of inflammation and oxidative stress, and rescued vasculogenic capacity of EPCs from T2DM."	( Dapagliflozin restores diabetes-associated decline in vasculogenic capacity of endothelial progenitor cells via activating AMPK-mediated inhibition of inflammation and oxidative stress. Chen, L; Dong, B; He, J; Liu, X; Luo, L; Qiu, Y; Xia, W; Zhang, J; Zhang, X; Zhou, Z, 2023)	3.07
"Dapagliflozin treatment resulted in significant reductions in ventricular repolarization parameters over the study period in the CVD group with diabetes."	( The effect of dapagliflozin therapy on ventricular repolarization parameters in electrocardiography in patients with diabetic cardiovascular disease. Açıkel, B; Ömür, SE; Zorlu, Ç, 2023)	1.99
"Dapagliflozin treatment significantly lowered systolic blood pressure by 5.5 mmHg and alanine aminotransferase levels."	( Comparison of therapeutic efficacy and safety of sitagliptin, dapagliflozin, or lobeglitazone adjunct therapy in patients with type 2 diabetes mellitus inadequately controlled on sulfonylurea and metformin: Third agent study. Hong, JH; Lim, S; Moon, JS; Seong, K, 2023)	1.87
"Dapagliflozin-treated mice displayed enhanced food intake and reduced energy expenditure. "	( Altered Metabolic Phenotypes and Hypothalamic Neuronal Activity Triggered by Sodium-Glucose Cotransporter 2 Inhibition. Jung, IH; Kim, JG; Kim, KK; Lee, BJ; Lee, HG; Lee, S; Nam-Goong, IS; Park, BS; Tu, TH; Yang, HR; Yang, S; Yeh, JY, 2023)	2.35
"Dapagliflozin treatment of HCT116 cells, which express SGLT2 but not UGT1A9, results in the loss of cell adhesion, whereas HepG2 cells, which express both SGLT2 and UGT1A9, are resistant to the adhesion-related effects of dapagliflozin."	( Dapagliflozin Inhibits Cell Adhesion to Collagen I and IV and Increases Ectodomain Proteolytic Cleavage of DDR1 by Increasing ADAM10 Activity. Nakajima, Y; Okada, J; Okada, S; Osaki, A; Ozawa, A; Pessin, JE; Saito, T; Shimoda, Y; Yamada, E; Yamada, M; Yokoo, H, 2020)	2.72
"Dapagliflozin treatment significantly reduced circulating hepcidin and ferritin concentrations while causing a significant increase in levels of the hepcidin inhibitor, erythroferrone, and a transient increase in erythropoietin."	( Dapagliflozin Suppresses Hepcidin And Increases Erythropoiesis. Abuaysheh, S; Batra, M; Chaudhuri, A; Dandona, P; Ghanim, H; Green, K; Hejna, J; Makdissi, A, 2020)	2.72
"Dapagliflozin-treated mice developed bacteraemia resulting in UPEC colonization of the spleen and liver at a higher frequency than controls."	( Hyperglucosuria induced by dapagliflozin augments bacterial colonization in the murine urinary tract. Adams, LG; Hanson, B; Jennings-Gee, J; Kock, ND; Saenkham, P; Subashchandrabose, S, 2020)	1.58
"Dapagliflozin treatment results' significantly surpassed improvement of metformin treatment nearly in all parameters."	( Dapagliflozin, a sodium glucose cotransporter 2 inhibitors, protects cardiovascular function in type-2 diabetic murine model. El-Domiaty, H; El-Nabi, SH; Fayez Ewida, S; Hanna, G; Saleh, S; Shabaan, A, 2020)	2.72
"Dapagliflozin treatment significantly reduced LVM in people with T2D and LVH. "	( A randomized controlled trial of dapagliflozin on left ventricular hypertrophy in people with type two diabetes: the DAPA-LVH trial. Brown, AJM; Gandy, S; Houston, JG; Lang, CC; McCrimmon, R; Struthers, AD, 2020)	2.28
"The dapagliflozin treatment increased islet and beta cell numbers in the two diabetic mice."	( Dapagliflozin promotes beta cell regeneration by inducing pancreatic endocrine cell phenotype conversion in type 2 diabetic mice. Cui, X; Feng, J; Gu, L; Hong, T; Lang, S; Le, Y; Liu, J; Wang, H; Wei, R; Wei, T; Yang, J; Yang, K, 2020)	2.48
"Dapagliflozin treatment increases hemoglobin and serum erythropoietin levels."	( Correction of anemia by dapagliflozin in patients with type 2 diabetes. Cain, V; Correa-Rotter, R; Greasley, PJ; Heerspink, HJL; Sartipy, P; Sjöström, CD; Stefánsson, BV; Wheeler, DC, 2020)	1.59
"Dapagliflozin treatment in combination with insulin resulted in a dose-dependent increase in haematocrit levels and RBCs over a 104 week period."	( Dapagliflozin effects on haematocrit, red blood cell count and reticulocytes in insulin-treated patients with type 2 diabetes. Aberle, J; Birkenfeld, AL; Jaeckel, E; Menzen, M; Rohwedder, K; Scheerer, MF; Schmid, SM; Tang, W; Terkamp, C; Xu, J, 2020)	2.72
"Dapagliflozin treatment increased glucose production in HK-2 cells and lowered blood glucose and induced gluconeogenesis in ob/ob mice."	( Resveratrol attenuates dapagliflozin-induced renal gluconeogenesis Cao, Z; Guo, X; Ma, Y; Shao, Y; Sun, X; Yuan, G; Zhang, J, 2021)	1.65
"In dapagliflozin-treated NASH mice, hypoglycemia was not identified during 24-hour casual blood glucose monitoring."	( Effects of Sodium-Glucose Cotransporter 2 Inhibition on Glucose Metabolism, Liver Function, Ascites, and Hemodynamics in a Mouse Model of Nonalcoholic Steatohepatitis and Type 2 Diabetes. Nakamoto, K; Tsubakimoto, M; Yabiku, K, 2020)	1.07
"Dapagliflozin treatment for 12 weeks is associated with improvement in hepatic fat content, a decrease in visceral fat and bodyweight, enhanced glycemic control, and improved liver biochemistry among T2DM patients with NAFLD."	( The effects of dapagliflozin on hepatic and visceral fat in type 2 diabetes patients with non-alcoholic fatty liver disease. Buranapin, S; Chattipakorn, N; Euathrongchit, J; Leerapun, A; Phrommintikul, A; Phrueksotsai, S; Pinyopornpanish, K; Thongsawat, S, 2021)	2.42
"Dapagliflozin-treated hearts had significantly increased connexin43 phosphorylation (p < 0.05), which was significantly decreased after adding 3-morpholinosydnonimine (p < 0.05)."	( Dapagliflozin attenuates arrhythmic vulnerabilities by regulating connexin43 expression via the AMPK pathway in post-infarcted rat hearts. Chen, SY; Chen, WT; Lee, CC; Lee, TM, 2021)	2.79
"Dapagliflozin treatment benefits to reduce HbA1c and FPG for type 1 diabetes."	( The efficacy of dapagliflozin for type 1 diabetes: a meta-analysis of randomized controlled studies. Fan, H; Liu, J; Ma, J; Zhao, Y, 2021)	2.41
"Dapagliflozin treatment (1.0 mg/kg/day) was administered for 4 weeks."	( Dapagliflozin attenuates human vascular endothelial cell activation and induces vasorelaxation: A potential mechanism for inhibition of atherogenesis. Dear, AE; Gaspari, T; Hu, Y; Liu, H; Simpson, RW; Spizzo, I; Widdop, RE, 2018)	2.64
"Dapagliflozin treatment specifically increased sucrose intake, which might be an ideal target for nutritional approaches to attenuate compensatory hyperphagia."	( Increased sugar intake as a form of compensatory hyperphagia in patients with type 2 diabetes under dapagliflozin treatment. Abiru, N; Ando, T; Haraguchi, A; Hongo, R; Horie, I; Ito, A; Kawakami, A; Nakamura, T; Natsuda, S; Sagara, I, 2018)	2.14
"Dapagliflozin or metformin treatment decreased insulin resistance, hypercholesterolemia, creatinine clearance and renal oxidative stress leading to improved renal function."	( Renal outcomes with sodium glucose cotransporter 2 (SGLT2) inhibitor, dapagliflozin, in obese insulin-resistant model. Chatsudthipong, V; Chattipakorn, N; Chueakula, N; Jaikumkao, K; Lungkaphin, A; Pongchaidecha, A; Thongnak, L; Wanchai, K, 2018)	1.44
"Dapagliflozin treatment, but not non-SGLT2 inhibitor treatment, significantly increased the LnRHI."	( The SGLT2 Inhibitor Dapagliflozin Significantly Improves the Peripheral Microvascular Endothelial Function in Patients with Uncontrolled Type 2 Diabetes Mellitus. Hieshima, K; Jinnouchi, H; Jinnouchi, K; Jinnouchi, T; Kajiwara, K; Kurinami, N; Miyamoto, F; Nishimura, H; Sugiyama, S; Suzuki, T; Yoshida, A, 2018)	1.53
"Dapagliflozin treatment improves arterial stiffness, endothelial dysfunction and vascular smooth muscle dysfunction, and subtly alters microbiota composition in type 2 diabetic mice. "	( SGLT2 inhibition via dapagliflozin improves generalized vascular dysfunction and alters the gut microbiota in type 2 diabetic mice. Battson, ML; Ecton, KE; Gentile, CL; Hou, S; Jarrell, DK; Lee, DM; Weir, TL, 2018)	2.24
"More dapagliflozintreated than saxagliptin-treated patients achieved the composite endpoint of HbA1c reduction ≥ 0.5%, weight loss ≥ 2 kg, SBP reduction ≥ 2 mmHg and no major/minor hypoglycemia (24% versus 7%)."	( Dapagliflozin versus saxagliptin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin. Chen, H; Garcia-Sanchez, R; Mathieu, C; Rosenstock, J; Saraiva, GL, 2018)	2.38
"Dapagliflozin treatment was more cost-effective compared with metformin treatment for Chinese type 2 diabetes patients. "	( Cost-effectiveness analysis of dapagliflozin treatment versus metformin treatment in Chinese population with type 2 diabetes. Cai, X; Chen, Y; Gu, S; Ji, L; Nie, L; Shi, L; Yang, W, 2019)	2.24
"Dapagliflozin treatment resulted in a significant reduction in body weight and blood glucose compared to vehicle-treated controls. "	( Effect of Dapagliflozin Treatment on the Expression of Renal Sodium Transporters/Channels on High-Fat Diet Diabetic Mice. Bindels, RJM; de Baaij, JHF; de Galan, BE; Gault, VA; Hoenderop, JGJ; Ma, C; Millar, PJ, 2019)	2.36
"Dapagliflozin or placebo treatment periods each lasted 6 weeks, with a 6-week washout period in between."	( Effects of dapagliflozin on urinary metabolites in people with type 2 diabetes. Darshi, M; Heerspink, HJL; Kim, JJ; Laverman, GD; Mulder, S; Pena, MJ; Sharma, K, 2019)	1.63
"Dapagliflozin treatment reduced the TmG and splay in both groups."	( Characterization of renal glucose reabsorption in response to dapagliflozin in healthy subjects and subjects with type 2 diabetes. Boulton, DW; Ching, A; DeFronzo, RA; Griffen, SC; Hompesch, M; Hong, Y; Kasichayanula, S; LaCreta, FP; Leslie, BR; Liu, X; Morrow, LA; Pfister, M, 2013)	1.35
"Dapagliflozin is a novel treatment choice for type 2 diabetes."	( Dapagliflozin treatment for type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. An, Z; Li, S; Song, H; Wu, B; Zhang, L; Zhang, M, 2014)	2.57
"Dapagliflozin treatment was associated with a reduction in HbA1c [weighted mean difference (WMD): -0.53%; 95% confidence interval (CI): -0.58% to -0.47%; p < 0.00001], fasting plasma glucose (WMD: -1.06 mmol/L; 95% CI: -1.20, -0.92; p < 0.00001), and body weight (WMD: -1.63 kg; 95% CI: -1.83, -1.43; p < 0.00001)."	( Dapagliflozin treatment for type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. An, Z; Li, S; Song, H; Wu, B; Zhang, L; Zhang, M, 2014)	2.57
"Dapagliflozin treatment induced glucosuria and markedly lowered fasting plasma glucose."	( Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production. Abdul-Ghani, MA; Daniele, G; DeFronzo, RA; Eldor, R; Fiorentino, TV; Merovci, A; Norton, L; Perez, Z; Solis-Herrera, C; Tripathy, D; Xiong, J, 2014)	2.57
"Dapagliflozin treatment is a cost-effective treatment alternative for Type 2 diabetes in all four Nordic countries."	( Cost-effectiveness of dapagliflozin (Forxiga®) added to metformin compared with sulfonylurea added to metformin in type 2 diabetes in the Nordic countries. Bergenheim, K; Ekman, M; Granström, O; McEwan, P; Sabale, U, 2015)	1.45
"Dapagliflozin treatment markedly decreased macrophage infiltration and the gene expression of inflammation and oxidative stress in the kidney of db/db mice."	( Long-term treatment with the sodium glucose cotransporter 2 inhibitor, dapagliflozin, ameliorates glucose homeostasis and diabetic nephropathy in db/db mice. Eguchi, J; Hatanaka, T; Horiguchi, CS; Makino, H; Nakatsuka, A; Nishii, N; Ogawa, D; Tachibana, H; Takei, K; Terami, N; Wada, J; Yamada, H, 2014)	1.36
"Dapagliflozin treatment is associated with weight reduction, it has a low intrinsic propensity to cause hypoglycemia, and it may offer the advantage of a complementary mechanism of action when added to other therapies."	( Dapagliflozin: a new sodium-glucose cotransporter 2 inhibitor for treatment of type 2 diabetes. Vivian, EM, 2015)	2.58
"The dapagliflozin treatment arm was associated with a mean incremental benefit of 0.467 quality-adjusted life years (QALYs) [95% confidence interval (CI): 0.420; 0.665], with an incremental cost of £1246 (95% CI: £613; £1637). "	( The cost-effectiveness of dapagliflozin versus sulfonylurea as an add-on to metformin in the treatment of Type 2 diabetes mellitus. Bergenheim, K; Callan, L; Charokopou, M; Lister, S; McEwan, P; Postema, R; Roudaut, M; Tolley, K; Townsend, R, 2015)	1.28
"Dapagliflozin treatment when added to insulin therapy in Japanese patients with type 2 diabetes remains to be evaluated."	( Efficacy and safety of dapagliflozin in addition to insulin therapy in Japanese patients with type 2 diabetes: Results of the interim analysis of 16-week double-blind treatment period. Araki, E; Asano, M; Ekholm, E; Johnsson, E; Kim, H; Onishi, Y; Yajima, T, 2016)	2.19
"Dapagliflozin treatment up to 104 weeks was well tolerated in older patients. "	( Long-Term Safety of Dapagliflozin in Older Patients with Type 2 Diabetes Mellitus: A Pooled Analysis of Phase IIb/III Studies. Fioretto, P; Johnsson, E; Mansfield, TA; Parikh, S; Ptaszynska, A; Yavin, Y, 2016)	2.2
"Dapagliflozin treatment showed beneficial effects on diabetic nephropathy, which might be via suppression of renal RAS component expression, oxidative stress and interstitial fibrosis in OLETF rats. "	( Effect of Sodium-Glucose Co-Transporter 2 Inhibitor, Dapagliflozin, on Renal Renin-Angiotensin System in an Animal Model of Type 2 Diabetes. Ahn, YB; Chung, S; Kim, ES; Kim, JW; Kim, MJ; Kim, SJ; Ko, SH; Lee, EM; Moon, SD; Shin, SJ; Yoo, YH, 2016)	2.13
"Dapagliflozin treatment decreased blood glucose concentration by 38% at day 7 and by 47% at day 14 and increased the urinary glucose excretion rate compared with the untreated diabetic animals. "	( Effect of Dapagliflozin Treatment on Fluid and Electrolyte Balance in Diabetic Rats. Chen, L; Efe, O; Klein, JD; LaRocque, LM; Sands, JM; Wang, J, 2016)	2.28
"Dapagliflozin treatment augmented the compensatory changes in medullary transport proteins in DM. "	( Effect of Dapagliflozin Treatment on Fluid and Electrolyte Balance in Diabetic Rats. Chen, L; Efe, O; Klein, JD; LaRocque, LM; Sands, JM; Wang, J, 2016)	2.28
"Dapagliflozin treatment demonstrated no persistent, clinically significant osmolarity, volume, or renal status changes."	( Sodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetes. Fiedorek, FT; List, JF; Morales, E; Tang, W; Woo, V, 2009)	1.34
"Dapagliflozin treatment at 10 and 20 mg QD for 12 weeks resulted in significant improvement in glycaemic control and body weight reduction in both early-stage and late-stage patients with T2DM. "	( Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: effects on glycaemic control and body weight. Feng, Y; Kasichayanula, S; List, J; Pfister, M; Zhang, L, 2010)	3.25
"In dapagliflozin-treated rats, β-cell mass was less variable and significant improvement in islet morphology was observed compared to vehicle-treated rats, although there was no change in mean β-cell mass with dapagliflozin."	( The novel sodium glucose transporter 2 inhibitor dapagliflozin sustains pancreatic function and preserves islet morphology in obese, diabetic rats. Jones, HB; Macdonald, FR; Mayers, RM; Peel, JE; Poucher, SM; Westgate, L; Whaley, JM, 2010)	1.13
"Dapagliflozin treatment increased the risk of urinary (OR 1.34; 1.05-1.71) and genital (OR 3.57; 2.59-4.93) tract infection; it also mildly increased the risk of hypoglycemia (OR 1.27; 1.05-1.53) when co-administered with insulin."	( A novel approach to control hyperglycemia in type 2 diabetes: sodium glucose co-transport (SGLT) inhibitors: systematic review and meta-analysis of randomized trials. Cassader, M; Gambino, R; Musso, G; Pagano, G, 2012)	1.1
"Treatment with dapagliflozin of patients with T2DM led to a reduction of fasting chylomicron remnants and increased postprandial ketone bodies compared to placebo suggesting enhanced hepatic fatty acid oxidation. "	( Effects of dapagliflozin on postprandial lipid metabolism in type 2 diabetes mellitus. Birnie, E; Burggraaf, B; Castro Cabezas, M; de Herder, WW; Fernández Arroyo, S; Huisbrink, J; Mulder, MT; Pouw, NMC; Rensen, PCN; van de Geijn, GM; van der Zwan, EM; van Vark-van der Zee, LC, 2022)	1.46
"Treatment with dapagliflozin was compared with treatment with placebo and resulted in a significantly greater change in HbA1c levels, fasting plasma glucose (FPG) and weight."	( The efficacy and safety of dapagliflozin combined with oral hypoglycemic agents in patients with type 2 diabetes: a systematic review and meta-analysis. Xu, W; Xu, X; Yan, Y; Zhuo, Q, 2022)	1.36
"Treatment with dapagliflozin attenuated LPS-induced endotoxic shock associated AKI and decreased the inflammatory cytokines in diabetic mice."	( Dapagliflozin Ameliorates Lipopolysaccharide Related Acute Kidney Injury in Mice with Streptozotocin-induced Diabetes Mellitus. Chi, PJ; Hsieh, YJ; Hsu, BG; Lee, CJ; Lu, CW, 2022)	2.5
"Treatment with dapagliflozin caused a significant reduction in plasma cTnT, pro-BNP and TNF-α levels concentrations compared to the DOX control group (p < 0.001)."	( Cardio-protective effect of dapagliflozin against doxorubicin induced cardiomyopathy in rats. Akdeniz, CS; Belen, E; Canbolat, IP; Cetinarslan, Ö; Erbas, O; Karaca, M; Sönmez, M; Yigittürk, G, 2022)	1.35
"Treatment with dapagliflozin improves cardiovascular outcomes across the spectrum of BMI, leads to greater symptom improvement in patients with obesity, compared with those without, and has the additional benefit of causing modest weight loss."	( Dapagliflozin for heart failure according to body mass index: the DELIVER trial. Adamson, C; Al Habeeb, W; Alcocer Gamba, MA; Bachus, E; Cabrera Honorio, JW; Claggett, B; de Boer, RA; Desai, AS; Hernandez, AF; Inzucchi, SE; Jhund, PS; Kondo, T; Kosiborod, MN; Lam, CSP; Langkilde, AM; Lindholm, D; Litwin, SE; Martinez, F; McMurray, JJV; Nguyen Vinh, P; Petersson, M; Shah, SJ; Solomon, SD; Vaduganathan, M; Wilderäng, U, 2022)	2.5
"Treatment with dapagliflozin is projected to extend event-free survival by up to 2.0 to 2.5 years among middle-aged and older individuals with HF with mildly reduced or preserved ejection fraction. "	( Estimated Long-Term Benefit of Dapagliflozin in Patients With Heart Failure. Claggett, BL; de Boer, RA; Desai, AS; Hernandez, AF; Inzucchi, SE; Jhund, P; Kosiborod, MN; Lam, CSP; Langkilde, AM; Lindholm, D; Martinez, F; McMurray, JJV; Petersson, M; Shah, SJ; Solomon, SD; Vaduganathan, M, 2022)	1.36
"Treatment with dapagliflozin failed to rescue glycolysis."	( Mapping the metabolic reprogramming induced by sodium-glucose cotransporter 2 inhibition. Abramovich, I; Agranovich, B; Ben-Haroush Schyr, R; Ben-Zvi, D; Bernal-Mizrachi, E; Cerasi, E; Gottlieb, E; Hinden, L; Kadosh, L; Kleiman, D; Kogot-Levin, A; Leibowitz, G; Mosenzon, O; Riahi, Y; Tam, J, 2023)	1.25
"Treatment with dapagliflozin was also associated with a lower risk of hospitalisations due to musculoskeletal and connective tissue disorders (HR 0·81 [0·67-0·99]) and infections and infastations (HR 0·86 [0·78-0·96])."	( Effects of dapagliflozin on hospitalisations in people with type 2 diabetes: post-hoc analyses of the DECLARE-TIMI 58 trial. Bhatt, DL; Cahn, A; Fredriksson, M; Gause-Nilsson, IAM; Goodrich, EL; Johansson, PA; Langkilde, AM; Leiter, LA; McGuire, DK; Mosenzon, O; Murphy, SA; Raz, I; Rozenberg, A; Sabatine, MS; Schechter, M; Wilding, JPH; Wiviott, SD; Yanuv, I; Zelniker, TA, 2023)	1.64
"How treatment with dapagliflozin differentially impacts hospitalization for HF of varying complexity is not well studied."	( Effects of dapagliflozin on heart failure hospitalizations according to severity of inpatient course: Insights from DELIVER and DAPA-HF. Chatur, S; Claggett, BL; de Boer, RA; Desai, AS; Docherty, K; Hernandez, AF; Inzucchi, SE; Jhund, PS; Kondo, T; Kosiborod, MN; Lam, CSP; Langkilde, AM; Martinez, FA; McMurray, JJV; Miao, ZM; Petersson, M; Shah, SJ; Solomon, SD; Vaduganathan, M, 2023)	1.62
"Treatment with dapagliflozin consistently reduced HF hospitalizations regardless of severity of inpatient course or LOS."	( Effects of dapagliflozin on heart failure hospitalizations according to severity of inpatient course: Insights from DELIVER and DAPA-HF. Chatur, S; Claggett, BL; de Boer, RA; Desai, AS; Docherty, K; Hernandez, AF; Inzucchi, SE; Jhund, PS; Kondo, T; Kosiborod, MN; Lam, CSP; Langkilde, AM; Martinez, FA; McMurray, JJV; Miao, ZM; Petersson, M; Shah, SJ; Solomon, SD; Vaduganathan, M, 2023)	1.64
"Treatment with dapagliflozin significantly reduced new loop diuretic requirement over time."	( Dapagliflozin and diuretic utilization in heart failure with mildly reduced or preserved ejection fraction: the DELIVER trial. Chatur, S; Claggett, B; de Boer, RA; Desai, AS; Haddad, T; Hernandez, AF; Inzucchi, SE; Jhund, PS; Kosiborod, MN; Lam, CSP; Maria Langkilde, A; Martinez, F; McMurray, JJV; Miao, ZM; Mitter, SS; Petersson, M; Shah, SJ; Solomon, SD; Vaduganathan, M; Vardeny, O, 2023)	2.69
"Treatment with dapagliflozin over 24 weeks provides similar clinically relevant improvements in metabolic and haemodynamic parameters, and similar reductions in UACR, in patients with T2D with elevated albuminuria treated with or without RASi at baseline."	( The effects of dapagliflozin on cardio-renal risk factors in patients with type 2 diabetes with or without renin-angiotensin system inhibitor treatment: a post hoc analysis. Cain, V; Correa-Rotter, R; Heerspink, HJL; Sartipy, P; Scholtes, RA; Sjöström, CD; Stefánsson, BV; Toto, RD; van Raalte, DH, 2020)	1.26
"Treatment with dapagliflozin significantly decreased blood glucose in the two diabetic models and upregulated plasma insulin and GLP-1 levels in db/db mice. "	( Dapagliflozin promotes beta cell regeneration by inducing pancreatic endocrine cell phenotype conversion in type 2 diabetic mice. Cui, X; Feng, J; Gu, L; Hong, T; Lang, S; Le, Y; Liu, J; Wang, H; Wei, R; Wei, T; Yang, J; Yang, K, 2020)	2.35
"Treatment with dapagliflozin can correct and prevent anemia in T2D patients. "	( Correction of anemia by dapagliflozin in patients with type 2 diabetes. Cain, V; Correa-Rotter, R; Greasley, PJ; Heerspink, HJL; Sartipy, P; Sjöström, CD; Stefánsson, BV; Wheeler, DC, 2020)	1.22
"Treatment with dapagliflozin and interval-based exercise lead to similar but small improvements in glycaemic variability compared with control and metformin therapy. "	( The effects of dapagliflozin, metformin or exercise on glycaemic variability in overweight or obese individuals with prediabetes (the PRE-D Trial): a multi-arm, randomised, controlled trial. Amadid, H; Blond, MB; Bruhn, L; Clemmensen, KKB; Dejgaard, TF; Færch, K; Jørgensen, ME; Karstoft, K; Pedersen, C; Persson, F; Ried-Larsen, M; Tvermosegaard, M; Vainø, CTR; Vistisen, D, 2021)	1.33
"Treatment with dapagliflozin significantly reduces ambulatory brachial and central BP levels and PWV in patients with type-2 diabetes mellitus. "	( Dapagliflozin decreases ambulatory central blood pressure and pulse wave velocity in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled clinical trial. Karagiannis, A; Kotsa, K; Loutradis, C; Minopoulou, I; Papadopoulou, E; Sarafidis, P; Theodorakopoulou, MP; Tsapas, A; Tzatzagou, G; Zografou, I, 2021)	2.42
"Treatment with dapagliflozin significantly decreased HbA1c from 8.4%±1.5% at baseline to 7.4%±1.2% at 24 weeks."	( Serum high-molecular-weight adiponectin and response to dapagliflozin in patients with type 2 diabetes and non-alcoholic fatty liver disease. Aso, Y; Iijima, T; Jojima, T; Kato, K; Niitani, T; Sagara, M; Tomaru, T; Usui, I, 2021)	1.21
"Treatment with dapagliflozin significantly improved glycated haemoglobin [-0.32 ± 0.10 vs. "	( Effect of short-term use of dapagliflozin on impaired awareness of hypoglycaemia in people with type 1 diabetes. de Galan, BE; Tack, CJ; van Meijel, LA, 2021)	1.27
"Treatment with dapagliflozin in T2DM was associated with reductions in HbA1c, weight and systolic blood pressure over time periods up to 2 years. "	( Dapagliflozin therapy for type 2 diabetes in primary care: Changes in HbA1c, weight and blood pressure over 2 years follow-up. Bailey, C; Blak, B; Emmas, C; Kok, M; Rigney, U; Wilding, J, 2017)	2.25
"Treatment with dapagliflozin for six months significantly improved glycemic control and reduced body weight without reducing muscle mass in T2DM patients."	( Dapagliflozin Reduces Fat Mass without Affecting Muscle Mass in Type 2 Diabetes. Hieshima, K; Jinnouchi, H; Jinnouchi, K; Jinnouchi, T; Kajiwara, K; Kurinami, N; Miyamoto, F; Nishimura, H; Sugiyama, S; Suzuki, T; Yoshida, A, 2018)	2.28
"Treatment with dapagliflozin prevented podocyte injury, glomerular pathology and renal fibrosis determined by second harmonic generation (SHG), nephrin, synaptopodin, collagen IV, and fibronectin immunofluorescence microscopy."	( The Sodium-Glucose Cotransporter 2 Inhibitor Dapagliflozin Prevents Renal and Liver Disease in Western Diet Induced Obesity Mice. Levi, M; Luo, Y; Myakala, K; Orlicky, DJ; Wang, D; Wang, X; Yang, P, 2018)	1.08
"Treatment with dapagliflozin might improve systemic metabolic parameters and decrease the EAT volume in diabetes mellitus patients, possibly contributing to risk reduction in cardiovascular events."	( The effect of dapagliflozin treatment on epicardial adipose tissue volume. Aizawa, Y; Fujita, S; Fuse, K; Ikeda, Y; Kishi, S; Kitazawa, H; Okabe, M; Sato, M; Sato, T; Takahashi, M; Yuasa, S, 2018)	1.19
"Treatment with dapagliflozin was safe and there was no difference in risk of hypoglycaemia compared with placebo."	( Dapagliflozin for prednisone-induced hyperglycaemia in acute exacerbation of chronic obstructive pulmonary disease. Brandjes, DPM; Gerards, MC; Gerdes, VEA; Hageman, IMG; Hoekstra, JBL; Kross, M; Patberg, KW; Potter van Loon, BJ; Snijders, D; Venema, GE; Vriesendorp, TM, 2018)	2.26
"Treatment with dapagliflozin, irbesartan, and especially their combination, produced significant reduction in albuminuria, improved renal function parameters, increased sRAGE level and improved inflammatory and oxidative markers, together with amelioration of renal histopathological changes."	( Renal protective effect of SGLT2 inhibitor dapagliflozin alone and in combination with irbesartan in a rat model of diabetic nephropathy. Abdel-Wahab, AF; Al-Harizy, RM; Bamagous, GA; ElSawy, NA; Ghamdi, SSA; Ibrahim, IA; Shahzad, N, 2018)	1.08
"Treatment with dapagliflozin reduced fasting glucose levels and insulin resistance (TP1)."	( Sequential Treatment Escalation with Dapagliflozin and Saxagliptin Improves Beta Cell Function in Type 2 Diabetic Patients on Previous Metformin Treatment: An Exploratory Mechanistic Study. Alghdban, MK; Fischer, A; Forst, T; Heise, T; Kapitza, C; Plum-Mörschel, L; Voswinkel, S; Weber, MM, 2018)	1.09
"Rats treated with dapagliflozin had lower mean SWP on EEG (20.4% versus 75.3% for untreated rats). "	( Highly selective SGLT2 inhibitor dapagliflozin reduces seizure activity in pentylenetetrazol-induced murine model of epilepsy. Christy, J; Erbas, O; Erdogan, A; Erdogan, MA; Solmaz, V; Taskiran, E; Yusuf, D, 2018)	1.1
"Treatment with dapagliflozin 10 mg resulted in correction of Mg concentrations in patients with T2D and hypomagnesemia."	( Correction of hypomagnesemia by dapagliflozin in patients with type 2 diabetes: A post hoc analysis of 10 randomized, placebo-controlled trials. Cain, V; Chertow, GM; Goldenberg, R; Sartipy, P; Sjöström, CD; Stefánsson, BV; Toto, RD, 2019)	1.15
"Treatment with dapagliflozin 2.5mg, 5mg, or 10mg once daily is accompanied by an increased risk of vulvovaginitis or balanitis, related to the induction of glucosuria. "	( Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. Johnsson, KM; List, JF; Parikh, SJ; Ptaszynska, A; Schmitz, B; Sugg, J, )	0.72
"Treatment with dapagliflozin add-on to saxagliptin plus metformin resulted in a greater mean HbA1c reduction than placebo (-0.82 vs. "	( Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes. Chen, H; Cook, W; Ekholm, E; Hansen, L; Hirshberg, B; Iqbal, N; Li, D; Mathieu, C; Ranetti, AE, 2015)	1.01
"Pretreatment with dapagliflozin reduced blood and bronchoalveolar lavage glucose concentrations and P. aeruginosa CFU in db/db mice towards those seen in WT."	( Dapagliflozin-lowered blood glucose reduces respiratory Pseudomonas aeruginosa infection in diabetic mice. Åstrand, A; Baines, DL; Baker, EH; Benjamin, A; Garnett, JP; Gill, S; Groves, H; Lundqvist, AJ; Orogo-Wenn, M; Smith, DM; Taylor, JD; Tregoning, JS; Walters, D; Wingren, C, 2017)	2.22

Excerpt	Reference	Relevance
" All adverse events were mild or moderate, with no imbalance in frequency between groups."	( Influence of hepatic impairment on the pharmacokinetics and safety profile of dapagliflozin: an open-label, parallel-group, single-dose study. Boulton, DW; Kasichayanula, S; LaCreta, FP; Liu, X; Pfister, M; Zhang, W, 2011)	0.6
" Adverse events (AEs) were more frequent with dapagliflozin (40."	( Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control: a phase II multicentre, randomized, double-blind, placebo-controlled trial. Azuma, H; Hayashi, N; Inoue, S; Kaku, K; Kiyosue, A; Langkilde, AM; Matsuoka, O; Parikh, S; Tokudome, T, 2013)	0.96
"The use of currently available antihyperglycemic agents can be limited by contraindications; cost; renal and hepatic dosage adjustments; dosing schedules; and adverse effects such as gastrointestinal upset, weight gain, and hypoglycemia."	( The clinical efficacy and safety of sodium glucose cotransporter-2 inhibitors in adults with type 2 diabetes mellitus. Harris, KB; Riser Taylor, S, 2013)	0.39
" Adverse events (AEs) were evaluated throughout 104 weeks."	( Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Parikh, S; Rohwedder, K; Sugg, J; Wilding, JP; Woo, V, 2014)	1.85
" Anticipated, pharmacologically mediated effects of glucosuria, osmotic diuresis, and mild electrolyte loss were observed, but there were no adverse effects at clinically relevant exposures, including in the kidneys or urogenital tract."	( Nonclinical toxicology assessments support the chronic safety of dapagliflozin, a first-in-class sodium-glucose cotransporter 2 inhibitor. Abell, LM; Dorr, TE; Graziano, MJ; Hagan, D; Janovitz, EB; Onorato, JM; Reilly, TP; Tirmenstein, M; Whaley, JM, )	0.37
"7% with placebo experienced ≥ 1 adverse event, mostly mild or moderate, and unrelated to study treatment."	( Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Inoue, S; Kaku, K; Kiyosue, A; Langkilde, AM; Tokudome, T; Ueda, N; Yang, J, 2014)	0.71
" Proportions of patients with adverse events (AEs) and prespecified parameters related to previous clinical observations and dapagliflozin's action were assessed."	( Safety profile of dapagliflozin for type 2 diabetes: pooled analysis of clinical studies for overall safety and rare events. Apanovitch, AM; de Bruin, TW; Johnsson, KM; List, JF; Parikh, SJ; Ptaszynska, A, 2014)	0.94
" Changes in HbA1c level, fasting plasma glucose and body weight, as well as adverse events, were assessed over 102 weeks."	( Efficacy and safety of dapagliflozin monotherapy in people with Type 2 diabetes: a randomized double-blind placebo-controlled 102-week trial. Bailey, CJ; List, JF; Morales Villegas, EC; Ptaszynska, A; Tang, W; Woo, V, 2015)	0.73
" Clinical trials published to date show that dapagliflozin is safe and effective as monotherapy or as an add-on to insulin or oral antidiabetic agents in patients with T2DM."	( Efficacy and safety of dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in diabetes mellitus. Fioretto, P; Giaccari, A; Sesti, G, 2015)	0.99
" In the placebo, dapagliflozin 5 and 10 mg groups, respectively: adverse events (AEs) occurred in 52."	( Efficacy and safety of dapagliflozin in Asian patients with type 2 diabetes after metformin failure: A randomized controlled trial. Han, P; Iqbal, N; Johnsson, E; Mansfield, T; Min, KW; Ptaszynska, A; T'Joen, C; Wang, B; Yang, W, 2016)	1.08
" Adverse events were similar with dapagliflozin (66%) and placebo (71%), and hypoglycaemia was rare (≤2%)."	( Efficacy and safety of triple therapy with dapagliflozin add-on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes. Chen, H; Garcia-Sanchez, R; González González, JG; Hansen, L; Herrera Marmolejo, M; Iqbal, N; Johnsson, E; Mathieu, C, 2016)	0.98
" However, their specific mechanism of action involves other pharmacodynamic consequences including potentially harmful adverse reactions."	( Pharmacological aspects of the safety of gliflozins. Faillie, JL, 2017)	0.46
" Similar proportions of patients reported ≥1 adverse event with saxagliptin (58."	( One-year efficacy and safety of saxagliptin add-on in patients receiving dapagliflozin and metformin. Aggarwal, N; Chen, H; Chin, A; Garcia-Hernandez, P; Hansen, L; Iqbal, N; Johnsson, E; Matthaei, S, 2016)	0.67
"The safety profile of SGLT2 inhibitors is well defined, and the adverse event profile is largely consistent with their mechanism of action."	( Update review of the safety of sodium-glucose cotransporter 2 inhibitors for the treatment of patients with type 2 diabetes mellitus. Carlson, CJ; Santamarina, ML, 2016)	0.43
" Safety and tolerability were assessed by collating data for overall adverse events (AEs) and AEs of special interest over the 24-week period."	( Efficacy and safety of dapagliflozin in Asian patients: A pooled analysis. Cain, VA; Ji, L; Johnsson, KM; Sjöström, CD; Yang, W; Zhou, Z, 2017)	0.77
" Safety was assessed in terms of adverse events, laboratory variables and vital signs."	( Efficacy and safety of dapagliflozin over 1 year as add-on to insulin therapy in Japanese patients with type 2 diabetes: the DAISY (Dapagliflozin Added to patients under InSulin therapY) trial. Araki, E; Asano, M; Kim, H; Onishi, Y; Yajima, T, 2017)	0.77
" Adverse events occurred in 82."	( Efficacy and safety of dapagliflozin over 1 year as add-on to insulin therapy in Japanese patients with type 2 diabetes: the DAISY (Dapagliflozin Added to patients under InSulin therapY) trial. Araki, E; Asano, M; Kim, H; Onishi, Y; Yajima, T, 2017)	0.77
"The incidence of renal-related adverse events (AEs) with canagliflozin in patients with type 2 diabetes mellitus from a pooled population of patients in 7 active- and placebo-controlled trials (N = 5598) and in a 104-week study vs glimepiride (N = 1450) was low and similar in canagliflozin and non-canagliflozin groups."	( Renal safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus. Balis, D; Canovatchel, W; Desai, M; Rosenthal, N; Sun, D; Xie, J; Yavin, Y, 2017)	0.46
" Frequently observed adverse events (AEs) were consistent with the drug's mechanism of action and were generally mild in intensity."	( Durability of response to dapagliflozin: a review of long-term efficacy and safety. Jabbour, S, 2017)	0.76
" Larger placebo-/comparator-controlled pools of 21 (≤208 weeks; dapagliflozin, n = 5936; control, n = 3403) and 30 trials (≥12 weeks; dapagliflozin, n = 9195; control, n = 4629) assessed the rare adverse events (AEs) of diabetic ketoacidosis (DKA) and lower limb amputation, respectively."	( Dapagliflozin in patients with type 2 diabetes mellitus: A pooled analysis of safety data from phase IIb/III clinical trials. Bailey, CJ; Jabbour, S; Karup, C; Langkilde, AM; Scheen, A; Seufert, J, 2018)	2.16
" Our discovery of canagliflozin-mediated simultaneous inhibition of GDH and ETC complex I in renal cells at clinically relevant concentrations, and their particular susceptibility to necrotic cell death during proliferation, provides a mechanistic rationale for the adverse effects observed especially in patients with preexisting chronic kidney disease or previous kidney injury characterized by sustained regenerative tubular epithelial cell proliferation."	( Canagliflozin mediated dual inhibition of mitochondrial glutamate dehydrogenase and complex I: an off-target adverse effect. Beneke, S; Delp, J; Dietrich, DR; Gutbier, S; Leist, M; Schlichenmaier, N; Secker, PF, 2018)	0.48
" After 24 weeks, incidences of adverse events and serious adverse events were similar between triple and dual therapy and between concomitant and sequential add-on regimens."	( Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin. Chen, H; Del Prato, S; Garcia-Sanchez, R; Hansen, L; Iqbal, N; Johnsson, E; Mathieu, C; Rosenstock, J, 2018)	0.78
"Dapagliflozin is effective and safe in patients with T2D also receiving metformin."	( Efficacy and Renal Safety of Dapagliflozin in Patients with Type 2 Diabetes Mellitus Also Receiving Metformin: A Real-Life Experience. Aiello, V; Brancato, D; Di Noto, A; Fleres, M; Provenzano, F; Provenzano, V; Saura, G; Scorsone, A; Spano, L, 2018)	2.21
"To assess the association between the use of sodium glucose cotransporter 2 (SGLT2) inhibitors and seven serious adverse events of current concern."	( Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study. Eliasson, B; Franzén, S; Gudbjörnsdottir, S; Hveem, K; Jonasson, C; Melbye, M; Pasternak, B; Svanström, H; Svensson, AM; Ueda, P, 2018)	0.48
"In this analysis of nationwide registers from two countries, use of SGLT2 inhibitors, as compared with GLP1 receptor agonists, was associated with an increased risk of lower limb amputation and diabetic ketoacidosis, but not with other serious adverse events of current concern."	( Sodium glucose cotransporter 2 inhibitors and risk of serious adverse events: nationwide register based cohort study. Eliasson, B; Franzén, S; Gudbjörnsdottir, S; Hveem, K; Jonasson, C; Melbye, M; Pasternak, B; Svanström, H; Svensson, AM; Ueda, P, 2018)	0.48
" DAPA plus SAXA was generally well tolerated and the incidence of adverse events was similar in both treatment arms."	( Sustained 52-week efficacy and safety of triple therapy with dapagliflozin plus saxagliptin versus dual therapy with sitagliptin added to metformin in patients with uncontrolled type 2 diabetes. Del Prato, S; Garcia-Sanchez, R; Handelsman, Y; Iqbal, N; Johnsson, E; Kurlyandskaya, R; Mathieu, C; Rosenstock, J, 2019)	0.76
" However, wide CIs for many comparisons suggest limited precision, and therefore clinically important adverse events cannot be ruled out."	( Comparative safety of the sodium glucose co-transporter 2 (SGLT2) inhibitors: a systematic review and meta-analysis. Aubrey-Bassler, K; Chibrikov, E; Curnew, D; Donnan, JR; Gamble, JM; Grandy, CA; Hache, J; Johnston, K; Marra, CA; Nguyen, H; Swab, M, 2019)	0.51
" The primary endpoint was the occurrence of adverse events such as hypoglycaemia and diabetic ketoacidosis."	( Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT-5): 52-week results from a randomized, open-label, phase III clinical trial. Araki, E; Asano, M; Fujii, H; Kim, H; Langkilde, AM; Ohashi, H; Okabe, T; Thoren, F; Tomonaga, O; Uchigata, Y; Watada, H; Yajima, T, 2020)	0.87
" Adverse events were observed in 88."	( Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT-5): 52-week results from a randomized, open-label, phase III clinical trial. Araki, E; Asano, M; Fujii, H; Kim, H; Langkilde, AM; Ohashi, H; Okabe, T; Thoren, F; Tomonaga, O; Uchigata, Y; Watada, H; Yajima, T, 2020)	0.87
"Acute kidney injury occurred less frequently with dapagliflozin, and adverse events suggestive of volume depletion were balanced between treatment groups, both irrespective of baseline estimated glomerular filtration rate, blood pressure, diuretic or loop diuretic use (interaction P values >0."	( Safety of dapagliflozin in a broad population of patients with type 2 diabetes: Analyses from the DECLARE-TIMI 58 study. Bhatt, DL; Bonaca, M; Cahn, A; Fredriksson, M; Gause-Nilsson, IAM; Hadjadj, S; Jermendy, G; Johansson, PA; Langkilde, AM; Leiter, LA; McGuire, DK; Mosenzon, O; Murphy, SA; Raz, I; Rozenberg, A; Sabatine, MS; Wilding, JPH; Wiviott, SD; Yanuv, I, 2020)	1.21
" To evaluate whether the currently registered doses of 5 and 10 mg are optimal for cardiorenal efficacy and safety, we characterized the relationship between dapagliflozin exposure and nonglycaemic cardiorenal risk markers as well as adverse events."	( Exposure-response relationships of dapagliflozin on cardiorenal risk markers and adverse events: A pooled analysis of 13 phase II/III trials. Heerspink, HJL; Koomen, JV; Stevens, J, 2020)	1.03
"We demonstrate that doses higher than 10 mg could provide additional beneficial effects in haematocrit, systolic blood pressure, urinary albumin-creatinine ratio and uric acid, without obvious increases in the rate of adverse events."	( Exposure-response relationships of dapagliflozin on cardiorenal risk markers and adverse events: A pooled analysis of 13 phase II/III trials. Heerspink, HJL; Koomen, JV; Stevens, J, 2020)	0.84
" Serious adverse events were reported in the dapagliflozin 5, 10 mg, and placebo groups (32 [11."	( Long-term efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT-2 study): 52-week results from a randomized controlled trial. Araki, E; Arya, N; Dandona, P; Iqbal, N; Lind, M; Mathieu, C; Phillip, M; Rudofsky, G; Scheerer, MF; Thorén, F, 2020)	1.1
" The outcomes included changes in HbA1c, FPG, body weight, SBP, DBP and adverse reactions."	( Efficacy and safety of dapagliflozin plus saxagliptin vs monotherapy as added to metformin in patients with type 2 diabetes: A meta-analysis. Li, M; Song, J; Ying, M; Zhuang, Y, 2020)	0.87
" Data on HHF, all-cause mortality, cardiovascular death, major adverse cardiovascular events (MACE), systolic blood pressure, body weight, glycated hemoglobin (HbA1c), and adverse events were collected for analysis."	( Effects of Dapagliflozin on Cardiovascular Events, Death, and Safety Outcomes in Patients with Heart Failure: A Meta-Analysis. Jiang, XY; Qu, Q; Sun, JY; Tang, C; Wang, ZY; Zheng, XD, 2021)	1.01
" Early initiation during an acute heart failure (AHF) hospitalization may facilitate decongestion, improve natriuresis, and facilitate safe transition to a beneficial outpatient therapy for both diabetes and heart failure."	( Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial. Aaron, M; Collins, SP; Cox, ZL; Davidson, BT; Fowler, M; Hernandez, GA; Iii, ATM; Jenkins, CA; Jr, FEH; Kampe, C; Lindenfeld, J; Lindsell, CJ; Miller, KF; Stubblefield, WB, 2021)	0.93
" Among the studied patients, those with diabetes had a higher risk of major adverse cardiovascular events including the development of heart failure."	( Dapagliflozin suppresses ER stress and protects doxorubicin-induced cardiotoxicity in breast cancer patients. Chang, WT; Chen, ZC; Ho, CH; Lin, YW; Liu, PY; Shih, JY, 2021)	2.06
" Study drug discontinuation and serious adverse events were similar according to treatment groups, irrespective of aetiology."	( Efficacy and safety of dapagliflozin according to aetiology in heart failure with reduced ejection fraction: insights from the DAPA-HF trial. Bengtsson, O; Butt, JH; Docherty, KF; Inzucchi, SE; Jhund, PS; Kosiborod, MN; Køber, L; Langkilde, AM; Martinez, FA; McMurray, JJV; Nicolau, JC; Petrie, MC; Ponikowski, P; Sabatine, MS; Schou, M; Sjöstrand, M; Solomon, SD; Verma, S, 2021)	0.93
" In addition, dapagliflozin was safe and well-tolerated, irrespective of aetiology."	( Efficacy and safety of dapagliflozin according to aetiology in heart failure with reduced ejection fraction: insights from the DAPA-HF trial. Bengtsson, O; Butt, JH; Docherty, KF; Inzucchi, SE; Jhund, PS; Kosiborod, MN; Køber, L; Langkilde, AM; Martinez, FA; McMurray, JJV; Nicolau, JC; Petrie, MC; Ponikowski, P; Sabatine, MS; Schou, M; Sjöstrand, M; Solomon, SD; Verma, S, 2021)	1.29
" The dual efficacy outcomes were CV death or heart failure hospitalisations, and major adverse cardiovascular events (MACE; CV death, myocardial infarction or ischaemic stroke)."	( The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus. Bhatt, DL; Cahn, A; Gause-Nilsson, I; Herrera, M; Kato, ET; Langkilde, AM; Leiter, LA; McGuire, DK; Merlini, P; Mosenzon, O; Murphy, SA; O'Donoghue, ML; Raz, I; Sabatine, MS; Šmahelová, A; Tankova, T; Wilding, JPH; Wiviott, SD, 2021)	0.92
"To investigate the efficacy and safety of dapagliflozin compared with placebo in men and women with HFrEF enrolled in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF)."	( Efficacy and Safety of Dapagliflozin in Men and Women With Heart Failure With Reduced Ejection Fraction: A Prespecified Analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure Trial. Bengtsson, O; Butt, JH; Diez, M; Docherty, KF; Jhund, PS; Katova, T; Kosiborod, MN; Køber, L; Langkilde, AM; Lindholm, D; Ljungman, CEA; Martinez, FA; McMurray, JJV; O'Meara, E; Ogunniyi, MO; Petrie, MC; Ponikowski, P; Sabatine, MS; Schou, M; Sjöstrand, M; Solomon, SD, 2021)	1.2
" Study drug discontinuation and serious adverse events were not more frequent in the dapagliflozin group than in the placebo group in either men or women."	( Efficacy and Safety of Dapagliflozin in Men and Women With Heart Failure With Reduced Ejection Fraction: A Prespecified Analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure Trial. Bengtsson, O; Butt, JH; Diez, M; Docherty, KF; Jhund, PS; Katova, T; Kosiborod, MN; Køber, L; Langkilde, AM; Lindholm, D; Ljungman, CEA; Martinez, FA; McMurray, JJV; O'Meara, E; Ogunniyi, MO; Petrie, MC; Ponikowski, P; Sabatine, MS; Schou, M; Sjöstrand, M; Solomon, SD, 2021)	1.16
" In addition, dapagliflozin was safe and well-tolerated irrespective of sex."	( Efficacy and Safety of Dapagliflozin in Men and Women With Heart Failure With Reduced Ejection Fraction: A Prespecified Analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure Trial. Bengtsson, O; Butt, JH; Diez, M; Docherty, KF; Jhund, PS; Katova, T; Kosiborod, MN; Køber, L; Langkilde, AM; Lindholm, D; Ljungman, CEA; Martinez, FA; McMurray, JJV; O'Meara, E; Ogunniyi, MO; Petrie, MC; Ponikowski, P; Sabatine, MS; Schou, M; Sjöstrand, M; Solomon, SD, 2021)	1.29
" Its most common dose-limiting adverse effect is nephrotoxicity."	( Effect of taxifolin/dapagliflozin combination on colistin-induced nephrotoxicity in rats. Kabel, AM; Salama, SA, 2021)	0.94
"The Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) study demonstrated risk reduction for kidney and cardiovascular outcomes with dapagliflozin versus placebo in participants with chronic kidney disease (CKD) with and without diabetes."	( Efficacy and Safety of Dapagliflozin by Baseline Glycemic Status: A Prespecified Analysis From the DAPA-CKD Trial. Bajaj, HS; Chertow, GM; Correa-Rotter, R; Heerspink, HJL; Hou, FF; Jongs, N; Langkilde, AM; McMurray, JJV; Persson, F; Rossing, P; Stefansson, BV; Toto, RD; Vart, P; Wheeler, DC, 2021)	1.49
" HbA1c, fasting plasma glucose (FPG), body weight, and other cardiometabolic variables and adverse events were evaluated."	( Long-term effectiveness and safety of quadruple combination therapy with empagliflozin versus dapagliflozin in patients with type 2 diabetes: 3-year prospective observational study. Jeon, HJ; Ku, EJ; Lee, DH; Oh, TK, 2021)	0.84
" The overall incidence of adverse events, cardiovascular events and mortality did not differ between the two groups."	( Long-term effectiveness and safety of quadruple combination therapy with empagliflozin versus dapagliflozin in patients with type 2 diabetes: 3-year prospective observational study. Jeon, HJ; Ku, EJ; Lee, DH; Oh, TK, 2021)	0.84
" The objective of this prespecified analysis of the dapagliflozin and prevention of adverse outcomes in chronic kidney disease trial (DAPA-CKD) was to assess efficacy and safety of dapagliflozin in a small subgroup of participants with FSGS confirmed by kidney biopsy."	( Safety and efficacy of dapagliflozin in patients with focal segmental glomerulosclerosis: a prespecified analysis of the dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial. Chertow, GM; Correa-Rotter, R; Greene, T; Heerspink, HJL; Hou, FF; Jongs, N; Langkilde, AM; McMurray, JJV; Nowicki, M; Rossing, P; Sjöström, CD; Stefansson, BV; Toto, RD; Wheeler, DC; Wittmann, I, 2022)	1.28
" Adverse events leading to study drug discontinuation were similar in both groups; there were fewer serious adverse events with dapagliflozin."	( Safety and efficacy of dapagliflozin in patients with focal segmental glomerulosclerosis: a prespecified analysis of the dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial. Chertow, GM; Correa-Rotter, R; Greene, T; Heerspink, HJL; Hou, FF; Jongs, N; Langkilde, AM; McMurray, JJV; Nowicki, M; Rossing, P; Sjöström, CD; Stefansson, BV; Toto, RD; Wheeler, DC; Wittmann, I, 2022)	1.24
" The tolerability profile of both drugs was quite good and no major adverse effects were reported in both study groups."	( Comparison Of Efficacy And Safety Profile Of Empagliflozin Versus Dapagliflozin As Add On Therapy In Type 2 Diabetic Patients. Akhtar, L; Atif, M; Babar, M; Hussain, M, )	0.37
" Adverse events were also assessed."	( The efficacy and safety of dapagliflozin combined with oral hypoglycemic agents in patients with type 2 diabetes: a systematic review and meta-analysis. Xu, W; Xu, X; Yan, Y; Zhuo, Q, 2022)	1.02
" In terms of the incidence of adverse drug reactions, the incidence of hypoglycemic events was not significantly different between the experimental and control groups."	( The efficacy and safety of dapagliflozin combined with oral hypoglycemic agents in patients with type 2 diabetes: a systematic review and meta-analysis. Xu, W; Xu, X; Yan, Y; Zhuo, Q, 2022)	1.02
" Adverse events occurred in 27 (69%) dapagliflozin-assigned participants and 19 (58%) placebo-assigned participants over 24 weeks, and in 29 (74%) participants who received dapagliflozin over 52 weeks."	( Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study. Isganaitis, E; Karlsson, C; Laffel, LM; Norjavaara, E; Ratnayake, J; Shehadeh, N; Tamborlane, WV; Van Name, M, 2022)	1.3
"To investigate the efficacy of dapagliflozin according to frailty status, using the Rockwood cumulative deficit approach, in DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure)."	( Efficacy and Safety of Dapagliflozin According to Frailty in Heart Failure With Reduced Ejection Fraction : A Post Hoc Analysis of the DAPA-HF Trial. Belohlávek, J; Bengtsson, O; Butt, JH; Chiang, CE; Dewan, P; Docherty, KF; Drożdż, J; Inzucchi, SE; Jhund, PS; Kitakaze, M; Kosiborod, MN; Køber, L; Langkilde, AM; Lindholm, D; Martinez, FA; McMurray, JJV; Merkely, B; Ponikowski, P; Sabatine, MS; Schou, M; Sjöstrand, M; Solomon, SD; Tereshchenko, S, 2022)	1.32
" Study drug discontinuation and serious adverse events were not more frequent with dapagliflozin than placebo, regardless of FI class."	( Efficacy and Safety of Dapagliflozin According to Frailty in Heart Failure With Reduced Ejection Fraction : A Post Hoc Analysis of the DAPA-HF Trial. Belohlávek, J; Bengtsson, O; Butt, JH; Chiang, CE; Dewan, P; Docherty, KF; Drożdż, J; Inzucchi, SE; Jhund, PS; Kitakaze, M; Kosiborod, MN; Køber, L; Langkilde, AM; Lindholm, D; Martinez, FA; McMurray, JJV; Merkely, B; Ponikowski, P; Sabatine, MS; Schou, M; Sjöstrand, M; Solomon, SD; Tereshchenko, S, 2022)	1.26
"In patients with T2DM with or at high atherosclerotic cardiovascular disease risk, dapagliflozin reduced risk for hospitalization for heart failure and renal outcomes regardless of baseline SBP, with no difference in adverse events of interest at any level of baseline SBP."	( Efficacy and Safety of Dapagliflozin in Type 2 Diabetes According to Baseline Blood Pressure: Observations From DECLARE-TIMI 58 Trial. Aylward, P; Bhatt, DL; Cahn, A; Dalby, AJ; Dellborg, M; Dimulescu, D; Furtado, RHM; Gause-Nilsson, I; Goodrich, EL; Langkilde, AM; Leiter, LA; McGuire, DK; Mosenzon, O; Murphy, SA; Nicolau, JC; Oude Ophuis, AJM; Raz, I; Sabatine, MS; Wilding, JPH; Wiviott, SD, 2022)	1.26
" For all patients in the study, drugs were evaluated for safety by documenting adverse drug reactions."	( Comparative Assessment of the Long-Term Effectiveness and Safety of Dapagliflozin and Empagliflozin as Add-on Therapy to Hypoglycemic Drugs in Patients with Type 2 Diabetes. Chen, HC; Yang, AY, 2022)	0.96
" The incidence of adverse drug reactions was approximately 7-8%."	( Comparative Assessment of the Long-Term Effectiveness and Safety of Dapagliflozin and Empagliflozin as Add-on Therapy to Hypoglycemic Drugs in Patients with Type 2 Diabetes. Chen, HC; Yang, AY, 2022)	0.96
" Its adverse effects include orthostatic hypotension, dehydration and urinary tract and genital infections caused by glycosuria."	( Evaluation of toxic effects of dapagliflozin on reproductive system in diabetic rats. Boran, T; Ercan, F; Karaca, BU; Köroğlu, AK; Özhan, G, 2022)	1.01
"Even if DAPA is found to have antioxidant effects, it may raise abnormal sperm counts through a mechanism completely independent of these effects and thus may not have a significant toxic effect on the male reproductive system."	( Evaluation of toxic effects of dapagliflozin on reproductive system in diabetic rats. Boran, T; Ercan, F; Karaca, BU; Köroğlu, AK; Özhan, G, 2022)	1.01
" The HR for major adverse CV events with dapagliflozin among insulin users (0."	( Efficacy and Safety of Dapagliflozin by Baseline Insulin Regimen and Dose: Post Hoc Analyses From DECLARE-TIMI 58. Bhatt, DL; Cahn, A; Gause-Nilsson, IAM; Goodrich, EL; Langkilde, AM; Leiter, LA; McGuire, DK; Mosenzon, O; Murphy, SA; Pollack, R; Raz, I; Rozenberg, A; Sabatine, MS; Wilding, JPH; Wiviott, SD; Yanuv, I, 2023)	1.49
"26 mm Hg) were comparable with those of dapagliflozin, and both drugs were safe and well-tolerated."	( Efficacy and Safety of Enavogliflozin versus Dapagliflozin as Add-on to Metformin in Patients with Type 2 Diabetes Mellitus: A 24-Week, Double-Blind, Randomized Trial. Cho, SA; Cho, SI; Chon, S; Han, KA; Hong, EG; Jeong, IK; Kim, DM; Kim, YH; Lee, BW; Nah, JJ; Sohn, TS; Son, JW; Song, HR; Yoon, KH, 2023)	1.44
" The incidence of treatment-emergent adverse events was similar between the groups (21."	( Efficacy and safety of enavogliflozin versus dapagliflozin added to metformin plus gemigliptin treatment in patients with type 2 diabetes: A double-blind, randomized, comparator-active study: ENHANCE-D study. Cho, JH; Han, JM; Han, JY; Han, KA; Kang, ES; Kang, JG; Kim, CS; Kim, KS; Kim, MK; Kim, NH; Kim, S; Kim, SH; Kim, SS; Kim, SY; Kim, TH; Kim, TN; Kim, YH; Koh, G; Lee, JH; Lee, KY; Lee, SE; Lim, S; Mok, JO; Nah, JJ; Park, CY; Park, JH; Song, HR; Song, KH; Won, KC, 2023)	1.17
" Both drugs were well-tolerated, with a similar incidence of adverse drug reactions."	( A Comparison of the Pharmacokinetics and Safety of Dapagliflozin Formate, an Ester Prodrug of Dapagliflozin, to Dapagliflozin Propanediol Monohydrate in Healthy Subjects. Chung, JY; Jang, IJ; Kim, E; Kim, HC; Lee, S; Sung, S, 2023)	1.16
" Evidence is lacking for optimal selection of effective and safe pharmaceuticals to slow the disease progression."	( Comparative effectiveness and safety for the treatments despite optimized renin-angiotensin system blockade among IgA nephropathy patients at high-risk of disease progression: A network meta-analysis of randomized controlled trials. Du, W; Fan, L; Ni, X; Tan, Q; Xue, H, 2023)	0.91
" The primary outcome was the proportion of patients with adverse events and serious adverse events, particularly key adverse events of special interest (AESI) including urinary tract infection, genital tract infection (typical symptoms with or without microbiological diagnosis) and hypoglycaemia (typical symptoms with or without blood glucose ≤3."	( A multicentre, prospective, non-interventional study evaluating the safety of dapagliflozin in patients with type 2 diabetes in routine clinical practice in China (DONATE). Chen, S; Guo, L; Li, L; Li, T; Qi, L; Wang, H; Wang, J; Yang, H; Yuan, L, 2023)	1.14
" Adverse events were reported in 35."	( A multicentre, prospective, non-interventional study evaluating the safety of dapagliflozin in patients with type 2 diabetes in routine clinical practice in China (DONATE). Chen, S; Guo, L; Li, L; Li, T; Qi, L; Wang, H; Wang, J; Yang, H; Yuan, L, 2023)	1.14
" However, cardiac adverse effects of CP interfere with its clinical benefit."	( Role of hypoxia inducible factor/vascular endothelial growth factor/endothelial nitric oxide synthase signaling pathway in mediating the cardioprotective effect of dapagliflozin in cyclophosphamide-induced cardiotoxicity. Abd El-Hameed, NM; Bayoumi, AM; Mahmoud Refaie, MM; Mokhemer, SA; Shehata, S, )	0.33
"Our data revealed that CP could induce cardiac damage as manifested by significant increases in cardiac enzymes, blood pressure, malondialdehyde (MDA), tumor necrosis factor alpha (TNFα), HIF1α, sodium glucose co-transporter 2 (SGLT2) and cleaved caspase-3 levels with toxic histopathological changes."	( Role of hypoxia inducible factor/vascular endothelial growth factor/endothelial nitric oxide synthase signaling pathway in mediating the cardioprotective effect of dapagliflozin in cyclophosphamide-induced cardiotoxicity. Abd El-Hameed, NM; Bayoumi, AM; Mahmoud Refaie, MM; Mokhemer, SA; Shehata, S, )	0.33
"05); the incidence of adverse reactions was lower in the combination grou [4."	( Efficacy and safety of dapagliflozin combined with insulin in overweight or obese individuals with type 2 diabetes. Gu, W; Li, X; Sun, D; Zhang, Y; Zheng, K, 2023)	1.22
" Among patients already on three HF medical therapies, the addition of dapagliflozin was safe without requiring de-escalation of other therapies."	( Influence of background medical therapy on efficacy and safety of dapagliflozin in patients with heart failure with improved ejection fraction in the DELIVER trial. Bhatt, AS; Chatur, S; Claggett, BL; de Boer, RA; Desai, AS; Fang, JC; Hernandez, AF; Jhund, P; Kosiborod, MN; Lam, CSP; Martinez, F; McMurray, JJV; Miao, ZM; Pabon, M; Shah, SJ; Solomon, SD; Vaduganathan, M; Vardeny, O; Wang, X, 2023)	1.38
" Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group."	( Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extensio Chung, CH; Han, KA; Hong, EG; Kim, DJ; Kim, ES; Kim, HJ; Koh, GP; Lee, CB; Moon, JS; Park, CY; Park, IR; Won, JC; Won, KC; Yoon, KH; Yu, JM, 2023)	1.16

Excerpt	Reference	Relevance
" Pharmacokinetic parameters for dapagliflozin in preclinical species revealed a compound with adequate oral exposure, clearance, and elimination half-life, consistent with the potential for single daily dosing in humans."	( In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans. Discenza, L; Ellsworth, BA; Humphreys, WG; Kasichayanula, S; Khanna, A; Komoroski, B; Koplowitz, B; Li, W; Meng, W; Obermeier, M; Washburn, W; Whaley, JM; Yao, M; Zhu, M, 2010)	0.9
" The current studies assessed the potential for pharmacokinetic (PK) interaction between dapagliflozin and pioglitazone, metformin, glimepiride or sitagliptin in healthy subjects following single-dose administration."	( Lack of pharmacokinetic interaction between dapagliflozin, a novel sodium-glucose transporter 2 inhibitor, and metformin, pioglitazone, glimepiride or sitagliptin in healthy subjects. Boulton, DW; Griffen, SC; Kasichayanula, S; LaCreta, FP; Li, T; Liu, X; Pfister, M; Shyu, WC; Zhang, W, 2011)	0.85
" Pharmacokinetic studies are recommended in subjects with impaired hepatic function if hepatic metabolism accounts for a substantial portion of the absorbed drug."	( Influence of hepatic impairment on the pharmacokinetics and safety profile of dapagliflozin: an open-label, parallel-group, single-dose study. Boulton, DW; Kasichayanula, S; LaCreta, FP; Liu, X; Pfister, M; Zhang, W, 2011)	0.6
" The aim of these studies was to assess the potential for pharmacokinetic interaction between dapagliflozin, a sodium glucose co-transporter-2 inhibitor being developed for the treatment of T2DM, and four medications commonly prescribed in patients with T2DM and cardiovascular disease: simvastatin, valsartan, warfarin, and digoxin."	( Lack of pharmacokinetic interactions between dapagliflozin and simvastatin, valsartan, warfarin, or digoxin. Boulton, DW; Chang, M; Griffen, SC; Kasichayanula, S; LaCreta, FP; Liu, X; Shyu, WC, 2012)	0.86
"Potential pharmacokinetic interactions between 20 mg dapagliflozin, 40 mg simvastatin, or 320 mg valsartan were assessed in an open-label, randomized, five-period, five-treatment, unbalanced crossover study in 24 healthy subjects."	( Lack of pharmacokinetic interactions between dapagliflozin and simvastatin, valsartan, warfarin, or digoxin. Boulton, DW; Chang, M; Griffen, SC; Kasichayanula, S; LaCreta, FP; Liu, X; Shyu, WC, 2012)	0.89
" Steady-state Cmax for dapagliflozin were 4%, 6% and 9% higher and for D3OG were 20%, 37% and 52% higher in patients with mild, moderate and severe renal impairment, respectively, compared with normal function."	( The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Boulton, DW; Humphreys, WG; Kasichayanula, S; LaCreta, FP; Liu, X; Pe Benito, M; Pfister, M; Yao, M, 2013)	0.98
"These studies assessed the single- and multiple-dose pharmacokinetic and pharmaco dynamic properties of dapagliflozin and its major inactive metabolite, dapagliflozin 3-O-glucuronide (D3OG), in healthy subjects residing in China."	( Pharmacokinetic and pharmacodynamic properties of single- and multiple-dose of dapagliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects. Boulton, DW; Bui, A; Chang, M; Griffen, SC; Kasichayanula, S; Lacreta, FP; Li, H; Liu, X; Yang, L, 2013)	0.83
" Pharmacokinetic parameters (plasma and urinary dapagliflozin and D3OG), pharmacodynamic response (urinary glucose excretion), and tolerability were assessed."	( Pharmacokinetic and pharmacodynamic properties of single- and multiple-dose of dapagliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects. Boulton, DW; Bui, A; Chang, M; Griffen, SC; Kasichayanula, S; Lacreta, FP; Li, H; Liu, X; Yang, L, 2013)	0.87
"Pharmacokinetic and pharmacodynamic characteristics following single- and multiple-dose dapagliflozin 5 and 10 mg oral administration in healthy Chinese subjects were as predicted from previous studies and were similar to findings observed in non-Chinese healthy subjects."	( Pharmacokinetic and pharmacodynamic properties of single- and multiple-dose of dapagliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects. Boulton, DW; Bui, A; Chang, M; Griffen, SC; Kasichayanula, S; Lacreta, FP; Li, H; Liu, X; Yang, L, 2013)	0.84
" The half-life for orally administered dapagliflozin 10 mg was 12."	( Clinical pharmacokinetics and pharmacodynamics of dapagliflozin, a selective inhibitor of sodium-glucose co-transporter type 2. Boulton, DW; Griffen, SC; Kasichayanula, S; Lacreta, F; Liu, X, 2014)	0.92
"An extensive literature search was performed to analyze the pharmacokinetic characteristics, toxicological issues and safety concerns of SGLT2 inhibitors in humans."	( Evaluating SGLT2 inhibitors for type 2 diabetes: pharmacokinetic and toxicological considerations. Scheen, AJ, 2014)	0.4
"The three pharmacological agents share an excellent oral bioavailability, long half-life allowing once-daily administration, low accumulation index and renal clearance, the absence of active metabolites and a limited propensity to drug-drug interactions."	( Evaluating SGLT2 inhibitors for type 2 diabetes: pharmacokinetic and toxicological considerations. Scheen, AJ, 2014)	0.4
"To compare the pharmacodynamic effects of the highest approved doses of the sodium glucose co-transporter 2 (SGLT2) inhibitors canagliflozin and dapagliflozin on urinary glucose excretion (UGE), renal threshold for glucose excretion (RTG ) and postprandial plasma glucose (PPG) excursion in healthy participants in a randomized, double-blind, two-period crossover study."	( Pharmacodynamic differences between canagliflozin and dapagliflozin: results of a randomized, double-blind, crossover study. Farrell, K; Ghosh, A; Natarajan, J; Pinheiro, J; Plum-Mörschel, L; Polidori, D; Rothenberg, P; Sha, S; Vaccaro, N, 2015)	0.87
" The available SGLT2 inhibitors share similar pharmacokinetic characteristics, with a rapid oral absorption, a long elimination half-life allowing once-daily administration, an extensive hepatic metabolism mainly via glucuronidation to inactive metabolites, the absence of clinically relevant drug-drug interactions and a low renal elimination as parent drug."	( Pharmacodynamics, efficacy and safety of sodium-glucose co-transporter type 2 (SGLT2) inhibitors for the treatment of type 2 diabetes mellitus. Scheen, AJ, 2015)	0.42
" These SGLT2 inhibitors share similar pharmacokinetic characteristics with a rapid oral absorption, a long elimination half-life allowing once-daily administration, an extensive hepatic metabolism mainly via glucuronidation to inactive metabolites and a low renal elimination as a parent drug."	( Pharmacokinetics, Pharmacodynamics and Clinical Use of SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease. Scheen, AJ, 2015)	0.42
" Duration and onset of the pharmacologic effects seemed to be closely correlated with the pharmacokinetic properties of each SGLT2 inhibitor, particularly with respect to high distribution and long retention in the target organ, the kidney."	( Characterization and comparison of sodium-glucose cotransporter 2 inhibitors in pharmacokinetics, pharmacodynamics, and pharmacologic effects. Imamura, M; Kurosaki, E; Tahara, A; Takasu, T; Yokono, M, 2016)	0.43
"To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) and safety profile of dapagliflozin in paediatric patients aged 10-17 years with type 2 diabetes mellitus (T2DM)."	( Pharmacokinetics and pharmacodynamics of dapagliflozin in children and adolescents with type 2 diabetes mellitus. Boulton, DW; Ismat, FA; LaCreta, F; Tang, W; Tirucherai, GS, 2016)	0.93
"This single-dose, open-label, randomized, 3-period, 3-treatment crossover drug-drug interaction study was conducted to evaluate differences in the pharmacokinetic properties of saxagliptin and dapagliflozin when coadministered."	( Lack of a Pharmacokinetic Interaction Between Saxagliptin and Dapagliflozin in Healthy Subjects: A Randomized Crossover Study. Boulton, DW; LaCreta, F; Liang, D; Lubin, S; Marion, AS; Reynolds, L; Vakkalagadda, B, 2016)	0.86
" Serial blood samples for determining saxagliptin, 5-hydroxy saxagliptin (5-OH saxagliptin; major active metabolite) and dapagliflozin plasma concentrations and pharmacokinetic parameters were collected before and up to 60 hours after the dose."	( Lack of a Pharmacokinetic Interaction Between Saxagliptin and Dapagliflozin in Healthy Subjects: A Randomized Crossover Study. Boulton, DW; LaCreta, F; Liang, D; Lubin, S; Marion, AS; Reynolds, L; Vakkalagadda, B, 2016)	0.88
"The results indicated that dapagliflozin had no effect on the pharmacokinetic properties of saxagliptin, 5-OH saxagliptin, or saxagliptin total active moiety and vice versa."	( Lack of a Pharmacokinetic Interaction Between Saxagliptin and Dapagliflozin in Healthy Subjects: A Randomized Crossover Study. Boulton, DW; LaCreta, F; Liang, D; Lubin, S; Marion, AS; Reynolds, L; Vakkalagadda, B, 2016)	0.97
"These data indicate that coadministration of saxagliptin and dapagliflozin exhibits no pharmacokinetic interaction and is well tolerated."	( Lack of a Pharmacokinetic Interaction Between Saxagliptin and Dapagliflozin in Healthy Subjects: A Randomized Crossover Study. Boulton, DW; LaCreta, F; Liang, D; Lubin, S; Marion, AS; Reynolds, L; Vakkalagadda, B, 2016)	0.92
" Areas covered: The saxagliptin plus dapagliflozin combination is carefully analysed, focusing on: 1) pharmacokinetic properties, 2) pharmacodynamics data, and 3) results of randomised controlled trials (dual combination versus either monotherapy, sequential therapy saxagliptin added to dapagliflozin or dapagliflozin added to saxagliptin)."	( Pharmacokinetic drug evaluation of saxagliptin plus dapagliflozin for the treatment of type 2 diabetes. Scheen, AJ, 2017)	0.98
" This study aimed to evaluate the effect of the coadministration of lobeglitazone and dapagliflozin on their individual pharmacokinetic properties at steady state in healthy male volunteers in the fasted state."	( Evaluation of the Pharmacokinetic Interaction Between Lobeglitazone and Dapagliflozin at Steady State. Jang, K; Jeon, JY; Kim, MG; Moon, SJ, 2020)	1.01
" Blood samples were taken periodically over a 48-h period after dosing to derive total plasma lobeglitazone and dapagliflozin pharmacokinetic properties; safety profile was evaluated throughout the study."	( Evaluation of the Pharmacokinetic Interaction Between Lobeglitazone and Dapagliflozin at Steady State. Jang, K; Jeon, JY; Kim, MG; Moon, SJ, 2020)	1
"Coadministration of lobeglitazone and dapagliflozin had no apparent clinically relevant effects on the pharmacokinetic properties of either drug."	( Evaluation of the Pharmacokinetic Interaction Between Lobeglitazone and Dapagliflozin at Steady State. Jang, K; Jeon, JY; Kim, MG; Moon, SJ, 2020)	1.06
" The effect of UGT1A9 polymorphisms on dapagliflozin apparent oral clearance (CL/F) was studied with dapagliflozin population pharmacokinetic data and UGT1A9 genotype data (I."	( Common UGT1A9 polymorphisms do not have a clinically meaningful impact on the apparent oral clearance of dapagliflozin in type 2 diabetes mellitus. Boulton, DW; Chang, R; Naagaard, MD; Någård, M; Tang, W, 2022)	1.2
" Therefore, changes in UGT1A9 activity caused by SOR may lead to pharmacokinetic interactions between the two drugs."	( Development of UPLC-MS/MS Method to Study the Pharmacokinetic Interaction between Sorafenib and Dapagliflozin in Rats. Cui, Y; Dong, Z; Fu, Y; He, X; Li, Y; Ma, Y; Xun, X, 2022)	0.94
" This study aimed to evaluate donafenib-dapagliflozin and donafenib-canagliflozin pharmacokinetic interactions and explore the potential mechanisms."	( In vivo assessment of the pharmacokinetic interactions between donafenib and dapagliflozin, donafenib and canagliflozin in rats. Dong, Z; Fu, Y; Guo, C; He, X; Li, Y; Wang, Z; Xun, X, 2023)	1.41
"gov identifier: NCT05343078 ) aimed at assessing the pharmacokinetic properties and safety of dapagliflozin in patients with kidney failure on regular dialysis regimens compared with those with type 2 diabetes and age- and sex-matched controls with normal kidney function."	( Pharmacokinetic Properties of Dapagliflozin in Hemodialysis and Peritoneal Dialysis Patients. Barreto, J; Borges, C; Bueno de Oliveira, R; Campos-Staffico, AM; Jesus, DC; Luiz da Costa, J; Nadruz, W; Rodrigues, TB; Sposito, AC, 2023)	1.42
"In patients with kidney failure on dialysis, dapagliflozin was well tolerated, was slightly dialyzable, and had nonaccumulating pharmacokinetic properties."	( Pharmacokinetic Properties of Dapagliflozin in Hemodialysis and Peritoneal Dialysis Patients. Barreto, J; Borges, C; Bueno de Oliveira, R; Campos-Staffico, AM; Jesus, DC; Luiz da Costa, J; Nadruz, W; Rodrigues, TB; Sposito, AC, 2023)	1.46
" This study evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) interactions between EV and sodium glucose cotransporter-2 inhibitors (SGLT2i) in healthy volunteers since combination therapy of DPP4i and SGLT2i has been considered as an effective option for T2DM treatment."	( Pharmacokinetic and pharmacodynamic drug-drug interactions between evogliptin and empagliflozin or dapagliflozin in healthy male volunteers. Choi, M; Hong, T; Jin, BH; Kim, CO; Kim, D; Park, MS; Yoo, BW, 2023)	1.13
" In addition, pharmacokinetic (PK) and safety comparisons of dapagliflozin and metformin across different regions were conducted to evaluate regional differences."	( Pharmacokinetic Variables of Dapagliflozin/Metformin Extended-release Fixed-dose Combination in Healthy Chinese Volunteers and Regional Comparison. Boulton, DW; Hui, A; Ning, R; Tang, W; Zhao, X, 2023)	1.44

Excerpt	Reference	Relevance
" It is often used in combination with conventional anti-diabetic drugs such as metformin, glimepiride, and insulin in treating type 2 diabetes (T2D)."	( The efficacy of dapagliflozin combined with hypoglycemic drugs in treating type 2 diabetes: protocol for meta-analysis of randomized controlled trials. Che, WS; Chen, X; Leung, SW; Sun, YN; Zhou, Y, 2013)	0.74
"Dapagliflozin combined with conventional antidiabetic drugs."	( The efficacy of dapagliflozin combined with hypoglycaemic drugs in treating type 2 diabetes mellitus: meta-analysis of randomised controlled trials. Che, WS; Chen, X; Leung, SW; Sun, YN; Zhou, Y, 2014)	2.19
" The urinary glucose excretion was drastically elevated in the dapagliflozin group, but the combination with mitiglinide suppressed it about 50%."	( Efficacy of Mitiglinide Combined with Dapagliflozin in Streptozotocin-nicotinamide-induced Type 2 Diabetic Rats and in Zucker Fatty Rats. Akahane, K; Inoue, T; Kiguchi, S; Kobayashi, M; Maruyama, K; Mori, Y; Ojima, K; Yaguchi, A; Yokoyama, A, 2015)	0.93
" Since the sodium-glucose cotransporter 2 inhibitors share common structural features, notably a glycoside moiety, investigation of drugs in this class for effects on UGT to identify (or exclude) potential drug-drug interactions is warranted."	( Inhibition of Human UDP-Glucuronosyltransferase Enzymes by Canagliflozin and Dapagliflozin: Implications for Drug-Drug Interactions. Chau, N; Miners, JO; Pattanawongsa, A; Rowland, A, 2015)	0.65
" We report here that a low-carbohydrate diet combined with an SGLT2 inhibitor was effective and safe to treat refractory hyperglycemia in the perioperative period in a type 2 diabetes patient complicated with a high titer of insulin antibodies."	( Low-carbohydrate diet combined with SGLT2 inhibitor for refractory hyperglycemia caused by insulin antibodies. Abiru, N; Ando, T; Horie, I; Kawakami, A; Shigeno, R, 2016)	0.43
" So, we investigated renal protective effects of SGLT2 inhibitor, dapagliflozin, alone and in combination with irbesartan in a rat model of diabetic nephropathy."	( Renal protective effect of SGLT2 inhibitor dapagliflozin alone and in combination with irbesartan in a rat model of diabetic nephropathy. Abdel-Wahab, AF; Al-Harizy, RM; Bamagous, GA; ElSawy, NA; Ghamdi, SSA; Ibrahim, IA; Shahzad, N, 2018)	0.98
" Our results showed that dapagliflozin in combination with a low dose of insulin significantly lowered hyperglycemia, hypercholesterolemia, and hypertriglyceridemia."	( Effect of dapagliflozin alone and in combination with insulin in a rat model of type 1 diabetes. Abdalla, O; Dessouki, A; Kilany, O; Sasaki, K; Sayed, N; Shimoda, M; Yoshida, T, 2020)	1.26
" Daily treatment with the full dose of insulin alone, dapagliflozin alone, or dapagliflozin in combination with a low dose of insulin was then initiated."	( Effects of dapagliflozin in combination with insulin on cytochrome P450 activities in a diabetes type 1 rat model. Abdalla, O; Dessouki, A; Kilany, O; Murata, I; Sasaki, K; Sayed, N, 2021)	1.26
" Which was unlike with other agents, indicating that the SGLT2 inhibitors might be effective alone or in combination with any other drugs."	( The efficacy and safety of dapagliflozin combined with oral hypoglycemic agents in patients with type 2 diabetes: a systematic review and meta-analysis. Xu, W; Xu, X; Yan, Y; Zhuo, Q, 2022)	1.02
"According to the available data, dapagliflozin combined with oral hypoglycemic agents can effectively reduce the level of HbA1c and body weight; however, it does not increase the incidence of hypoglycemia but can cause urinary tract infection and genital infection."	( The efficacy and safety of dapagliflozin combined with oral hypoglycemic agents in patients with type 2 diabetes: a systematic review and meta-analysis. Xu, W; Xu, X; Yan, Y; Zhuo, Q, 2022)	1.3
" The control group was treated with lifestyle intervention, while the intervention group was treated with dapagliflozin combined with lifestyle intervention."	( Efficacy of Dapagliflozin Combined with Lifestyle Intervention in Obesity Control. Dai, W; Peng, Q, 2022)	1.31
"Dapagliflozin in combination with a lifestyle intervention effectively and safely treats excess weight in middle-aged and older adults, reverses obesity-related markers, and improves psychological symptoms."	( Efficacy of Dapagliflozin Combined with Lifestyle Intervention in Obesity Control. Dai, W; Peng, Q, 2022)	2.54
"To find the effects of dapagliflozin in combination with metoprolol sustained-release tablets on cardiac function and prognosis in acute myocardial infarction patients after PCI."	( Effects of Dapagliflozin in Combination with Metoprolol Sustained-Release Tablets on Prognosis and Cardiac Function in Patients with Acute Myocardial Infarction after PCI. Liu, Z; Zhang, H, 2022)	1.42
" However, no studies have explored the long-term metabolic effects of SGLT2i, combined with dietary carbohydrate restriction."	( The DAPA-DIET study: Metabolic response to Dapagliflozin combined with dietary carbohydrate restriction in patients with Type 2 Diabetes Mellitus and Obesity-A longitudinal cohort study. Barber, TM; Chatha, K; Cuthbertson, DJ; Hanson, P; O'Hare, PJ; Parsons, N; Randeva, H; Reidy, G; Weickert, MO, 2022)	0.98
" These results offer a scientific and clinical rationale to conduct an exploratory trial investigating the effects of a low carbohydrate diet combined with SGLT2 inhibitors in patients with T2D."	( The DAPA-DIET study: Metabolic response to Dapagliflozin combined with dietary carbohydrate restriction in patients with Type 2 Diabetes Mellitus and Obesity-A longitudinal cohort study. Barber, TM; Chatha, K; Cuthbertson, DJ; Hanson, P; O'Hare, PJ; Parsons, N; Randeva, H; Reidy, G; Weickert, MO, 2022)	0.98
" The purpose of this open-label, 1-sequence crossover study was to determine whether drug-drug interactions between sparsentan and dapagliflozin affect dapagliflozin pharmacokinetics (PK)."	( Effect of Multiple Doses of Sparsentan on the Single-Dose Pharmacokinetics of Dapagliflozin: An Open-Label Drug-Drug Interaction Study in Healthy Adults. Cai, D; Chen, SC; Liu, K; Nguyen, M; Preciado, P; Verma, N; Winnett, C, 2023)	1.34
" We assessed the albuminuria-lowering efficacy and safety of the ERA zibotentan combined with the SGLT2 inhibitor dapagliflozin."	( Zibotentan in combination with dapagliflozin compared with dapagliflozin in patients with chronic kidney disease (ZENITH-CKD): a multicentre, randomised, active-controlled, phase 2b, clinical trial. Ambery, P; Åstrand, M; Carlson, G; Greasley, PJ; Heerspink, HJL; Kiyosue, A; Lin, M; Mercier, AK; Ueckert, S; Wheeler, DC; Wijkmark, E, 2023)	1.41
"Zibotentan combined with dapagliflozin reduced albuminuria with an acceptable tolerability and safety profile and is an option to reduce chronic kidney disease progression in patients already receiving currently recommended therapy."	( Zibotentan in combination with dapagliflozin compared with dapagliflozin in patients with chronic kidney disease (ZENITH-CKD): a multicentre, randomised, active-controlled, phase 2b, clinical trial. Ambery, P; Åstrand, M; Carlson, G; Greasley, PJ; Heerspink, HJL; Kiyosue, A; Lin, M; Mercier, AK; Ueckert, S; Wheeler, DC; Wijkmark, E, 2023)	1.5

Excerpt	Reference	Relevance
"To determine the absolute oral bioavailability (F(p."	( Simultaneous oral therapeutic and intravenous ¹⁴C-microdoses to determine the absolute oral bioavailability of saxagliptin and dapagliflozin. Arnold, ME; Boulton, DW; Christopher, LJ; Kasichayanula, S; Keung, CF; Lacreta, F; Xu, XS, 2013)	0.6
"Nitric oxide (NO) bioavailability was reduced by TNFα and both EMPA and DAPA restored NO levels in TNFα-stimulated HCAECs."	( Empagliflozin and Dapagliflozin Reduce ROS Generation and Restore NO Bioavailability in Tumor Necrosis Factor α-Stimulated Human Coronary Arterial Endothelial Cells. Albrecht, M; Boomsma, M; Hollmann, MW; Homayr, A; Juni, RP; Kerindongo, R; Koolwijk, P; Preckel, B; Spin, EL; Uthman, L; van Hinsbergh, VWM; Weber, NC; Zuurbier, CJ, 2019)	0.85
"These data suggest that EMPA and DAPA rather restore NO bioavailability by inhibiting ROS generation than by affecting eNOS expression or signaling, barrier function and adhesion molecules expression in TNFα-induced endothelial cells."	( Empagliflozin and Dapagliflozin Reduce ROS Generation and Restore NO Bioavailability in Tumor Necrosis Factor α-Stimulated Human Coronary Arterial Endothelial Cells. Albrecht, M; Boomsma, M; Hollmann, MW; Homayr, A; Juni, RP; Kerindongo, R; Koolwijk, P; Preckel, B; Spin, EL; Uthman, L; van Hinsbergh, VWM; Weber, NC; Zuurbier, CJ, 2019)	0.85
" Interestingly, a faster absorption rate was observed for the peptide formulated within the cyclodextrin vehicle with respect to the buffer vehicle, which could trigger an earlier onset of action."	( Developing an injectable co-formulation of two antidiabetic drugs: Excipient impact on peptide aggregation and pharmacokinetic properties. Broo, A; Corkill, D; Coward, S; Goodman, J; Houvenagel, S; Jermutus, L; Jones, I; Lainé, AL; Petrone, M; Rose, J; Sandinge, AS; Santos, ALGD, 2020)	0.56

Excerpt	Relevance	Reference
" Pharmacokinetic parameters for dapagliflozin in preclinical species revealed a compound with adequate oral exposure, clearance, and elimination half-life, consistent with the potential for single daily dosing in humans."	( In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans. Discenza, L; Ellsworth, BA; Humphreys, WG; Kasichayanula, S; Khanna, A; Komoroski, B; Koplowitz, B; Li, W; Meng, W; Obermeier, M; Washburn, W; Whaley, JM; Yao, M; Zhu, M, 2010)	0.9
" Dapagliflozin has demonstrated sustained, dose-dependent glucosuria over 24 hours with once-daily dosing in clinical trials."	( Sodium-glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitus. Campbell, RK; Neumiller, JJ; White, JR, 2010)	1.27
" Dapagliflozin in combination and as monotherapy was dosed at 5 mg (Study 1) and 10 mg (Study 2)."	( Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Hennicken, D; Henry, RR; List, JF; Marmolejo, MH; Murray, AV; Ptaszynska, A, 2012)	2.73
") ) of saxagliptin and dapagliflozin using simultaneous intravenous ¹⁴C-microdose/therapeutic oral dosing (i."	( Simultaneous oral therapeutic and intravenous ¹⁴C-microdoses to determine the absolute oral bioavailability of saxagliptin and dapagliflozin. Arnold, ME; Boulton, DW; Christopher, LJ; Kasichayanula, S; Keung, CF; Lacreta, F; Xu, XS, 2013)	0.91
"micro + oraltherap dosing is a valuable tool to assess human absolute bioavailability."	( Simultaneous oral therapeutic and intravenous ¹⁴C-microdoses to determine the absolute oral bioavailability of saxagliptin and dapagliflozin. Arnold, ME; Boulton, DW; Christopher, LJ; Kasichayanula, S; Keung, CF; Lacreta, F; Xu, XS, 2013)	0.6
"The use of currently available antihyperglycemic agents can be limited by contraindications; cost; renal and hepatic dosage adjustments; dosing schedules; and adverse effects such as gastrointestinal upset, weight gain, and hypoglycemia."	( The clinical efficacy and safety of sodium glucose cotransporter-2 inhibitors in adults with type 2 diabetes mellitus. Harris, KB; Riser Taylor, S, 2013)	0.39
" No clear dose-response relationship between dapagliflozin and genital infection was demonstrated."	( Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. Johnsson, KM; List, JF; Parikh, SJ; Ptaszynska, A; Schmitz, B; Sugg, J, )	0.63
"5 h), accumulation (defined as the geometric mean ratio of AUC(τ) at day 10 to AUC(τ) at day 1) after multiple dosing was minimal (<1."	( Pharmacokinetic and pharmacodynamic properties of single- and multiple-dose of dapagliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects. Boulton, DW; Bui, A; Chang, M; Griffen, SC; Kasichayanula, S; Lacreta, FP; Li, H; Liu, X; Yang, L, 2013)	0.62
" Dapagliflozin dosing was well tolerated."	( Pharmacokinetic and pharmacodynamic properties of single- and multiple-dose of dapagliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects. Boulton, DW; Bui, A; Chang, M; Griffen, SC; Kasichayanula, S; Lacreta, FP; Li, H; Liu, X; Yang, L, 2013)	1.53
"Dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 (SGLT2), has been shown to improve glycaemic control, stabilize insulin dosing and mitigate insulin-associated weight gain over 48 weeks in patients whose type 2 diabetes mellitus (T2DM) was inadequately controlled despite high doses of insulin."	( Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Parikh, S; Rohwedder, K; Sugg, J; Wilding, JP; Woo, V, 2014)	3.29
"Dapagliflozin improved glycaemic control, stabilized insulin dosing and reduced weight without increasing major hypoglycaemic episodes over 104 weeks in patients whose T2DM was inadequately controlled on insulin."	( Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Parikh, S; Rohwedder, K; Sugg, J; Wilding, JP; Woo, V, 2014)	3.29
" After dosing for 4 weeks, exenatide, dapagliflozin and exenatide + dapagliflozin similarly decreased haemoglobin A1c (HbA1c)."	( Combined antidiabetic benefits of exenatide and dapagliflozin in diabetic mice. D'Souza, LJ; Janssen, S; Parkes, DG; Polizzi, C; Tatarkiewicz, K; Villescaz, C; Wang, Y, 2014)	0.93
" Dosing considerations are required for the elderly, renally impaired, and patients at risk for hypotension."	( Sodium glucose co-transporter 2 inhibitors: a novel approach to the management of type 2 diabetes mellitus. Davis, CS; Fleming, JW; Warrington, LE, 2014)	0.4
" At 13 weeks of age, ZF rats were dosed orally with dapagliflozin once daily up to the 22(nd) day."	( Efficacy of Mitiglinide Combined with Dapagliflozin in Streptozotocin-nicotinamide-induced Type 2 Diabetic Rats and in Zucker Fatty Rats. Akahane, K; Inoue, T; Kiguchi, S; Kobayashi, M; Maruyama, K; Mori, Y; Ojima, K; Yaguchi, A; Yokoyama, A, 2015)	0.94
"To evaluate the efficacy and safety of twice-daily dosing of dapagliflozin and metformin, exploring the feasibility of a fixed-dose combination."	( Twice-daily dapagliflozin co-administered with metformin in type 2 diabetes: a 16-week randomized, placebo-controlled clinical trial. Burgess, L; de Bruin, TW; Hamer-Maansson, JE; Hruba, V; Korányi, L; Schumm-Draeger, PM, 2015)	1.04
" Thus, prescribing information should be consulted regarding dosage adjustments or restrictions in the case of renal dysfunction for each SGLT2 inhibitor."	( Pharmacokinetics, Pharmacodynamics and Clinical Use of SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease. Scheen, AJ, 2015)	0.42
"5% to 1% and fasting plasma glucose by ~15 to 35 mg/dL, depending on the agent and the dosage used, and are also associated with modest reductions in weight (-1."	( The Role of Sodium-Glucose Co-Transporter 2 Inhibitors in the Treatment of Type 2 Diabetes. Miller, S; Onge, ES; Whalen, K, 2015)	0.42
" Two pharmacokinetic (PK) studies were conducted to establish bioequivalence for 2 doses of dapagliflozin/metformin XR FDC versus the same dosage of the individual component (IC) tablets in healthy adults."	( Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects. Boulton, DW; Chang, M; Cui, D; Griffen, SC; LaCreta, F; Liang, D; Liu, X; Lubin, S; Quamina-Edghill, D, 2015)	0.88
" Participants received single oral doses or once-daily dosing of dapagliflozin/metformin XR (5 mg/500 mg [study 1] or 10 mg/1000 mg [study 2]) for 4 days in an FDC formulation or corresponding strengths of IC tablets."	( Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects. Boulton, DW; Chang, M; Cui, D; Griffen, SC; LaCreta, F; Liang, D; Liu, X; Lubin, S; Quamina-Edghill, D, 2015)	0.9
" Once-daily dosing to steady state of each FDC tablet had no effect on the PK properties of dapagliflozin or metformin."	( Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects. Boulton, DW; Chang, M; Cui, D; Griffen, SC; LaCreta, F; Liang, D; Liu, X; Lubin, S; Quamina-Edghill, D, 2015)	0.88
"2%), the lack of metformin Cmax being associated with efficacy or tolerability concerns, and the fasted state not being the recommended state for dosing of metformin XR."	( Fed and Fasted Single-dose Assessment of Bioequivalence of Dapagliflozin and Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects. Boulton, DW; Chang, M; Griffen, SC; Kitaura, C; LaCreta, F; Lubin, S; Pollack, A, 2016)	0.68
" PK/PD characteristics were similar to those observed in adults with T2DM, thereby supporting the hypothesis that the same dapagliflozin dosage as that used in adults can be evaluated in future phase III paediatric studies."	( Pharmacokinetics and pharmacodynamics of dapagliflozin in children and adolescents with type 2 diabetes mellitus. Boulton, DW; Ismat, FA; LaCreta, F; Tang, W; Tirucherai, GS, 2016)	0.91
" These results support the planned dosage strategy for a phase III dapagliflozin safety and efficacy study in paediatric patients with T2DM, for whom treatment options are currently limited."	( Comparison of the exposure-response relationship of dapagliflozin in adult and paediatric patients with type 2 diabetes mellitus. Boulton, DW; Hamrén, B; Johansson, CC; Parkinson, J; Tang, W, 2016)	0.92
" The increased risk of UTIs and genital infections seemed to have a dose-response relationship for dapagliflozin only."	( Urinary tract and genital infections in patients with type 2 diabetes treated with sodium-glucose co-transporter 2 inhibitors: A meta-analysis of randomized controlled trials. Dong, Y; Fang, Z; Li, D; Shen, S; Tang, H; Wang, T, 2017)	0.67
" Only dapagliflozin had a dose-response relationship with UTIs and genital infections."	( Urinary tract and genital infections in patients with type 2 diabetes treated with sodium-glucose co-transporter 2 inhibitors: A meta-analysis of randomized controlled trials. Dong, Y; Fang, Z; Li, D; Shen, S; Tang, H; Wang, T, 2017)	0.94
" The high-fat (HF) diet-induced obese insulin-resistant rats were divided into 4 groups and received the following treatments for 28 days: vehicle (HFV); vildagliptin at a dosage of 3 mg/kg/day (HFVil); dapagliflozin at a dosage of 1 mg/kg/day (HFDa) and combination drugs (HFDaVil)."	( Cardioprotection of dapagliflozin and vildagliptin in rats with cardiac ischemia-reperfusion injury. Chattipakorn, N; Chattipakorn, SC; Sa-Nguanmoo, P; Siri-Angkul, N; Sivasinprasasn, S; Tanajak, P; Thummasorn, S, 2018)	0.99
"SGLT2 inhibitors canagliflozin and dapagliflozin resulted in a weight and A1c-independent reduction of ALT levels compared to incretin agents, with a dose-response observed at higher baseline ALT levels."	( SGLT2 inhibitors and incretin agents: Associations with alanine aminotransferase activity in type 2 diabetes. Aronson, R; Bajaj, HS; Bhullar, L; Brown, RE; Kalra, S; Sohi, N, 2018)	0.76
"The PK and safety profiles of dapagliflozin in Japanese patients with T1D were consistent with previous studies, but with an unanticipated attenuation of the PD dose-response measured as UGE."	( Pharmacokinetics and pharmacodynamics of dapagliflozin in combination with insulin in Japanese patients with type 1 diabetes. Araki, E; Asano, M; Boulton, DW; Kim, H; Shiramoto, M; Tang, W; Thorén, F; Ueda, S; Watada, H; Yajima, T, 2019)	1.07
" The high selectivity of the proposed method allowed analysis of DGF in dosage form and human plasma samples with average recovery values of 99."	( New spectrofluorimetric analysis of dapagliflozin after derivatization with NBD-Cl in human plasma using factorial design experiments. Abdel Hamid, MA; Ahmed, HM; Batakoushy, HA; Omar, MA, 2019)	0.79
" Moreover, the dose-response relationship and chronic pharmacological studies of SU-011 were assessed in streptozotocin (STZ)-induced diabetic model, a STZ-treated model with impaired insulin secretion."	( A novel SGLT2 inhibitor, SU-011, improves glycaemic control in rodents without the risk of hypoglycaemia and weight gain. Bi, J; Cheng, X; Dai, F; Hao, L; Huang, F; Liu, Y; Wang, C; Xu, K, 2019)	0.51
" We induced isolated renal tubular glucosuria by dosing cats with the SGLT2i dapagliflozin."	( The effect of the sodium-glucose cotransporter type-2 inhibitor dapagliflozin on glomerular filtration rate in healthy cats. Burchell, R; Burton, SE; Gal, A; Jacob, A; Lopez-Villalobos, N; Malabu, U; Singh, P; Weidgraaf, K, 2020)	1.03
" The proposed method was successively applied to DGF analysis in both its pure and pharmaceutical dosage forms."	( Second-derivative synchronous spectrofluorimetric assay of dapagliflozin: Application to stability study and pharmaceutical preparation. Abdel Hamid, MA; Ahmed, HM; Batakoushy, HA; Omar, MA, 2020)	0.8
" Secondary endpoints included changes in glycaemic parameters, total daily insulin dosage and body weight over time."	( Efficacy and safety of dapagliflozin in Japanese patients with inadequately controlled type 1 diabetes (DEPICT-5): 52-week results from a randomized, open-label, phase III clinical trial. Araki, E; Asano, M; Fujii, H; Kim, H; Langkilde, AM; Ohashi, H; Okabe, T; Thoren, F; Tomonaga, O; Uchigata, Y; Watada, H; Yajima, T, 2020)	0.87
" Blood samples were taken periodically over a 48-h period after dosing to derive total plasma lobeglitazone and dapagliflozin pharmacokinetic properties; safety profile was evaluated throughout the study."	( Evaluation of the Pharmacokinetic Interaction Between Lobeglitazone and Dapagliflozin at Steady State. Jang, K; Jeon, JY; Kim, MG; Moon, SJ, 2020)	1
" Variations in filtered glucose across clinical studies were shown to drive the apparent differences in the glucosuria dose-response relationships among the gliflozins."	( Differentiating the Sodium-Glucose Cotransporter 1 Inhibition Capacity of Canagliflozin vs. Dapagliflozin and Empagliflozin Using Quantitative Systems Pharmacology Modeling. Boulton, DW; Chu, L; Greasley, PJ; Helmlinger, G; Johansson, S; Penland, RC; Peskov, K; Sokolov, V; Tang, W; Yakovleva, T, 2020)	0.78
" As a pharmaceutical dosage form DPG has immense importance as an individual drug and with other antidiabetic drugs as combinations."	( Pharmaceutical Analytical Profile for Novel SGL-2 Inhibitor: Dapagliflozin. Bobade, PS; Dhote, AM; Ganorkar, SB; Patil, MR; Sharma, SS; Shirkhedkar, AA, 2021)	0.86
" This study deals with an oral combined dosage form design for two anti-diabetic drugs, sitagliptin and dapagliflozin using self-nanoemulsifying drug delivery systems (SNEDDS)."	( Development and optimization of sitagliptin and dapagliflozin loaded oral self-nanoemulsifying formulation against type 2 diabetes mellitus. Ahmad, A; Alanazi, FK; Aldughaim, MS; Alqahtani, A; Alqahtani, AS; Kazi, M; Noman, OM, 2021)	1.09
" As a guide to determining dosing regimens in pediatric studies, the verified PBPK model, along with UGT enzyme ontogeny maturation understanding, was used for predictions of dapagliflozin monotherapy exposures in pediatric subjects aged 1 month to 18 years that best matched exposure in adult patients with a 10-mg single dose of dapagliflozin."	( Model-Informed Pediatric Dose Selection for Dapagliflozin by Incorporating Developmental Changes. Boulton, DW; Jo, H; Parkinson, J; Pilla Reddy, V; Tang, W, 2021)	1.08
" HbA1c, weight and daily insulin dosage was recorded at baseline and 6 months follow-up."	( Dapagliflozin: The outcome of use as add-on therapy in real-life clinical setting -An Audit. Raja, UY; Saravanan, P, 2021)	2.06
"In these T1DM patients, dosages were not incorporated into model, indicating no significant dose-response relationship between 5 and 10 mg/day affecting loss of weight."	( Quantifying the relationship between dapagliflozin and loss of weight in type 1 diabetes mellitus patients. Han, Y; He, SM; Wang, DD; Wang, TY; Wang, YM, 2022)	0.99
"A simple, precise, and rapid stability-indicating reversed-phase-HPLC method was developed and validated for the estimation of metformin (MET), dapagliflozin (DAP), and saxagliptin (SAX) combination in bulk and tablet dosage forms."	( Stability-indicating HPLC method development and validation for simultaneous estimation of metformin, dapagliflozin, and saxagliptin in bulk drug and pharmaceutical dosage form. Alegete, P; Boodida, S; Vankalapati, KR, 2022)	1.14
"The aim of this work is to develop four simple, accurate, and precise UV-spectrophotometric methods, three univariate and one multivariate, for the estimation of dapagliflozin and saxagliptin in their pure and marketed dosage forms."	( Univariate and Multivariate Determination of Dapagliflozin and Saxagliptin in Bulk and Dosage Form. Elhassan, MM; Hegazy, MA; Mahmoud, AM; Mowaka, S, 2023)	1.37
" The specificity of the proposed methods was studied by analyzing different laboratory-prepared mixtures and their combined pharmaceutical dosage form."	( Univariate and Multivariate Determination of Dapagliflozin and Saxagliptin in Bulk and Dosage Form. Elhassan, MM; Hegazy, MA; Mahmoud, AM; Mowaka, S, 2023)	1.17
" Steady-state concentrations of sparsentan following daily dosing did not affect the PK of single-dose dapagliflozin in healthy adults."	( Effect of Multiple Doses of Sparsentan on the Single-Dose Pharmacokinetics of Dapagliflozin: An Open-Label Drug-Drug Interaction Study in Healthy Adults. Cai, D; Chen, SC; Liu, K; Nguyen, M; Preciado, P; Verma, N; Winnett, C, 2023)	1.35
" The geometric mean ratio and confidence interval of the main PK parameters (maximum concentration of the drug in plasma at steady state and area under the plasma drug concentration-time curve within a dosing interval at a steady state) between EV and either EP or DP alone were not significantly altered by co-administration."	( Pharmacokinetic and pharmacodynamic drug-drug interactions between evogliptin and empagliflozin or dapagliflozin in healthy male volunteers. Choi, M; Hong, T; Jin, BH; Kim, CO; Kim, D; Park, MS; Yoo, BW, 2023)	1.13
"0), and the surface under the cumulative ranking curve (SUCRA) score was allotted to each dosage of different SGLT-2i."	( Dose-dependent renoprotection efficacy of sglt2 inhibitors in type 2 diabetes: systematic review and network meta-analysis. Bhattacharjee, S; Gamad, N; Hegde, NC; Kasudhan, KS; Kumar, A; Kumar, V; Patil, AN; Rastogi, A, 2023)	0.91
" Volunteers in cohort 2 received a higher dosage in a similar manner (dapagliflozin [10 mg] and metformin XR [1000 mg])."	( Pharmacokinetic Variables of Dapagliflozin/Metformin Extended-release Fixed-dose Combination in Healthy Chinese Volunteers and Regional Comparison. Boulton, DW; Hui, A; Ning, R; Tang, W; Zhao, X, 2023)	1.44
"57) d] and the difference in the dosage of insulin statistically significant (all P<0."	( Efficacy and safety of dapagliflozin combined with insulin in overweight or obese individuals with type 2 diabetes. Gu, W; Li, X; Sun, D; Zhang, Y; Zheng, K, 2023)	1.22
"It may be concluded that this method is stability-indicating and specific, and it can be successfully applied to analyze tablet dosage forms containing dapagliflozin."	( Analytical Method Development, Validation and Forced Degradation Study of Dapagliflozin by RP-HPLC. Chaudhari, U; Dande, PR; Sahu, JK, 2023)	1.34
"In patients with HFimpEF, the safety and efficacy of dapagliflozin were largely similar by background use and dosing of HF medical therapies."	( Influence of background medical therapy on efficacy and safety of dapagliflozin in patients with heart failure with improved ejection fraction in the DELIVER trial. Bhatt, AS; Chatur, S; Claggett, BL; de Boer, RA; Desai, AS; Fang, JC; Hernandez, AF; Jhund, P; Kosiborod, MN; Lam, CSP; Martinez, F; McMurray, JJV; Miao, ZM; Pabon, M; Shah, SJ; Solomon, SD; Vaduganathan, M; Vardeny, O; Wang, X, 2023)	1.4
" Future clinical trials are necessary to study the nephroprotective effects of the combined treatment at a low dosage in patients with diabetes."	( Dapagliflozin and metformin in combination ameliorates diabetic nephropathy by suppressing oxidative stress, inflammation, and apoptosis and activating autophagy in diabetic rats. Htun, KT; Jaikumkao, K; Kothan, S; Lungkaphin, A; Montha, N; Pengrattanachot, N; Phengpol, N; Promsan, S; Sriburee, S; Sutthasupha, P; Thongnak, L, 2024)	2.89

Role	Description
hypoglycemic agent	A drug which lowers the blood glucose level.
sodium-glucose transport protein subtype 2 inhibitor	Any inhibitor that interferes with the action of sodium-glucose transport protein subtype 2.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Class	Description
C-glycosyl compound	A glycosyl compound arising formally from the elimination of water from a glycosidic hydroxy group and an H atom bound to a carbon atom, thus creating a C-C bond.
aromatic ether	Any ether in which the oxygen is attached to at least one aryl substituent.
monochlorobenzenes	Any member of the class of chlorobenzenes containing a mono- or poly-substituted benzene ring in which only one substituent is chlorine.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Sodium/glucose cotransporter 1	Homo sapiens (human)	IC50 (µMol)	1.9084	0.0607	1.6105	8.4440	AID1075134; AID1153750; AID1396971; AID1436776; AID1447832; AID1546222; AID1570080; AID441050; AID443605; AID444173; AID466463; AID487640; AID589968; AID670284; AID703959
Sodium/glucose cotransporter 2	Homo sapiens (human)	IC50 (µMol)	0.0022	0.0005	0.1653	4.1000	AID1075135; AID1076412; AID1153749; AID1192797; AID1396969; AID1396970; AID1436777; AID1447831; AID1496228; AID1546223; AID1570081; AID1888489; AID441048; AID444172; AID462924; AID466464; AID484634; AID487637; AID497192; AID538620; AID551417; AID570205; AID589967; AID598854; AID601552; AID614528; AID619653; AID670283; AID703960
Sodium/myo-inositol cotransporter 2	Homo sapiens (human)	IC50 (µMol)	0.3800	0.3800	52.1900	104.0000	AID589976
Solute carrier family 5 member 4	Homo sapiens (human)	IC50 (µMol)	0.0014	0.0009	0.0696	0.2600	AID599006
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Cholinesterase	Homo sapiens (human)	EC50 (µMol)	0.0024	0.0024	0.0024	0.0024	AID674700
Sodium/glucose cotransporter 1	Homo sapiens (human)	EC50 (µMol)	0.8661	0.0011	1.2544	8.3000	AID1348754; AID1546902; AID1798018; AID318037; AID554362; AID674701
Sodium/glucose cotransporter 2	Homo sapiens (human)	EC50 (µMol)	0.1752	0.0011	0.1107	1.3900	AID1348753; AID1546903; AID1798018; AID318036; AID418688; AID554361; AID674700
Sodium/glucose cotransporter 2	Rattus norvegicus (Norway rat)	EC50 (µMol)	0.0030	0.0030	0.0030	0.0030	AID318039; AID418690
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Process	via Protein(s)	Taxonomy
xenobiotic metabolic process	Cholinesterase	Homo sapiens (human)
learning	Cholinesterase	Homo sapiens (human)
negative regulation of cell population proliferation	Cholinesterase	Homo sapiens (human)
neuroblast differentiation	Cholinesterase	Homo sapiens (human)
peptide hormone processing	Cholinesterase	Homo sapiens (human)
response to alkaloid	Cholinesterase	Homo sapiens (human)
cocaine metabolic process	Cholinesterase	Homo sapiens (human)
negative regulation of synaptic transmission	Cholinesterase	Homo sapiens (human)
response to glucocorticoid	Cholinesterase	Homo sapiens (human)
response to folic acid	Cholinesterase	Homo sapiens (human)
choline metabolic process	Cholinesterase	Homo sapiens (human)
acetylcholine catabolic process	Cholinesterase	Homo sapiens (human)
chloride transmembrane transport	Sodium/glucose cotransporter 1	Homo sapiens (human)
glucose transmembrane transport	Sodium/glucose cotransporter 1	Homo sapiens (human)
alpha-glucoside transport	Sodium/glucose cotransporter 1	Homo sapiens (human)
intestinal D-glucose absorption	Sodium/glucose cotransporter 1	Homo sapiens (human)
response to inorganic substance	Sodium/glucose cotransporter 1	Homo sapiens (human)
pentose transmembrane transport	Sodium/glucose cotransporter 1	Homo sapiens (human)
fucose transmembrane transport	Sodium/glucose cotransporter 1	Homo sapiens (human)
galactose transmembrane transport	Sodium/glucose cotransporter 1	Homo sapiens (human)
myo-inositol transport	Sodium/glucose cotransporter 1	Homo sapiens (human)
transepithelial water transport	Sodium/glucose cotransporter 1	Homo sapiens (human)
renal glucose absorption	Sodium/glucose cotransporter 1	Homo sapiens (human)
glucose import across plasma membrane	Sodium/glucose cotransporter 1	Homo sapiens (human)
sodium ion import across plasma membrane	Sodium/glucose cotransporter 1	Homo sapiens (human)
intestinal hexose absorption	Sodium/glucose cotransporter 1	Homo sapiens (human)
transport across blood-brain barrier	Sodium/glucose cotransporter 1	Homo sapiens (human)
glucose transmembrane transport	Sodium/glucose cotransporter 1	Homo sapiens (human)
sodium ion transport	Sodium/glucose cotransporter 1	Homo sapiens (human)
alpha-glucoside transport	Sodium/glucose cotransporter 2	Homo sapiens (human)
carbohydrate metabolic process	Sodium/glucose cotransporter 2	Homo sapiens (human)
hexose transmembrane transport	Sodium/glucose cotransporter 2	Homo sapiens (human)
renal glucose absorption	Sodium/glucose cotransporter 2	Homo sapiens (human)
glucose import across plasma membrane	Sodium/glucose cotransporter 2	Homo sapiens (human)
sodium ion import across plasma membrane	Sodium/glucose cotransporter 2	Homo sapiens (human)
sodium ion transport	Sodium/glucose cotransporter 2	Homo sapiens (human)
sodium ion transport	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
apoptotic process	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
polyol transmembrane transport	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
myo-inositol transport	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
glucose transmembrane transport	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
sodium ion transmembrane transport	Solute carrier family 5 member 4	Homo sapiens (human)
proton transmembrane transport	Solute carrier family 5 member 4	Homo sapiens (human)
sodium ion transport	Solute carrier family 5 member 4	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
amyloid-beta binding	Cholinesterase	Homo sapiens (human)
catalytic activity	Cholinesterase	Homo sapiens (human)
acetylcholinesterase activity	Cholinesterase	Homo sapiens (human)
cholinesterase activity	Cholinesterase	Homo sapiens (human)
protein binding	Cholinesterase	Homo sapiens (human)
hydrolase activity, acting on ester bonds	Cholinesterase	Homo sapiens (human)
enzyme binding	Cholinesterase	Homo sapiens (human)
choline binding	Cholinesterase	Homo sapiens (human)
identical protein binding	Cholinesterase	Homo sapiens (human)
galactose transmembrane transporter activity	Sodium/glucose cotransporter 1	Homo sapiens (human)
glucose transmembrane transporter activity	Sodium/glucose cotransporter 1	Homo sapiens (human)
myo-inositol:sodium symporter activity	Sodium/glucose cotransporter 1	Homo sapiens (human)
water transmembrane transporter activity	Sodium/glucose cotransporter 1	Homo sapiens (human)
glucose:sodium symporter activity	Sodium/glucose cotransporter 1	Homo sapiens (human)
protein binding	Sodium/glucose cotransporter 1	Homo sapiens (human)
pentose transmembrane transporter activity	Sodium/glucose cotransporter 1	Homo sapiens (human)
fucose transmembrane transporter activity	Sodium/glucose cotransporter 1	Homo sapiens (human)
alpha-glucoside transmembrane transporter activity	Sodium/glucose cotransporter 1	Homo sapiens (human)
galactose:sodium symporter activity	Sodium/glucose cotransporter 1	Homo sapiens (human)
D-glucose transmembrane transporter activity	Sodium/glucose cotransporter 1	Homo sapiens (human)
low-affinity glucose:sodium symporter activity	Sodium/glucose cotransporter 2	Homo sapiens (human)
glucose:sodium symporter activity	Sodium/glucose cotransporter 2	Homo sapiens (human)
protein binding	Sodium/glucose cotransporter 2	Homo sapiens (human)
alpha-glucoside transmembrane transporter activity	Sodium/glucose cotransporter 2	Homo sapiens (human)
D-glucose transmembrane transporter activity	Sodium/glucose cotransporter 2	Homo sapiens (human)
myo-inositol transmembrane transporter activity	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
protein binding	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
polyol transmembrane transporter activity	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
glucose:sodium symporter activity	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
glucose:sodium symporter activity	Solute carrier family 5 member 4	Homo sapiens (human)
protein binding	Solute carrier family 5 member 4	Homo sapiens (human)
proton transmembrane transporter activity	Solute carrier family 5 member 4	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
extracellular region	Cholinesterase	Homo sapiens (human)
nuclear envelope lumen	Cholinesterase	Homo sapiens (human)
endoplasmic reticulum lumen	Cholinesterase	Homo sapiens (human)
blood microparticle	Cholinesterase	Homo sapiens (human)
plasma membrane	Cholinesterase	Homo sapiens (human)
extracellular space	Cholinesterase	Homo sapiens (human)
early endosome	Sodium/glucose cotransporter 1	Homo sapiens (human)
plasma membrane	Sodium/glucose cotransporter 1	Homo sapiens (human)
apical plasma membrane	Sodium/glucose cotransporter 1	Homo sapiens (human)
brush border membrane	Sodium/glucose cotransporter 1	Homo sapiens (human)
intracellular organelle	Sodium/glucose cotransporter 1	Homo sapiens (human)
perinuclear region of cytoplasm	Sodium/glucose cotransporter 1	Homo sapiens (human)
extracellular exosome	Sodium/glucose cotransporter 1	Homo sapiens (human)
intracellular vesicle	Sodium/glucose cotransporter 1	Homo sapiens (human)
plasma membrane	Sodium/glucose cotransporter 1	Homo sapiens (human)
plasma membrane	Sodium/glucose cotransporter 2	Homo sapiens (human)
membrane	Sodium/glucose cotransporter 2	Homo sapiens (human)
apical plasma membrane	Sodium/glucose cotransporter 2	Homo sapiens (human)
extracellular exosome	Sodium/glucose cotransporter 2	Homo sapiens (human)
plasma membrane	Sodium/glucose cotransporter 2	Homo sapiens (human)
plasma membrane	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
apical plasma membrane	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
plasma membrane	Sodium/myo-inositol cotransporter 2	Homo sapiens (human)
plasma membrane	Solute carrier family 5 member 4	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Assay ID	Title	Year	Journal	Article
AID1775449	Antidiabetic activity in high fat diet-induced obese Sprague-Dawley rat model assessed as reduction in plasma glucose AUC (0 to 60 mins) at 5 mg/kg, po administered for 10 weeks under HFD condition followed by overnight fasting prior to compound redosing
AID1348755	Selectivity ratio of EC50 for human SGLT1 expressed in CHO cells to EC50 for human SGLT2 expressed in CHO cells	2018	European journal of medicinal chemistry, Jan-01, Volume: 143	Identification of an oxime-containing C-glucosylarene as a potential inhibitor of sodium-dependent glucose co-transporter 2.
AID570205	Inhibition of human SGLT2 expressed in CHO cells assessed as [14C]-alpha-methyl-D-glucopyranoside uptake after 2 hrs by liquid scintillation counting	2011	ACS medicinal chemistry letters, Feb-10, Volume: 2, Issue:2	Synthesis and SAR of Thiazolylmethylphenyl Glucoside as Novel C-Aryl Glucoside SGLT2 Inhibitors.
AID1570081	Inhibition of human full length SGLT2 expressed in NIH3T3 cells measured after 1 hr in presence of [14C]-methyl-alpha -D-glucopyranoside by scintillation counter method	2019	European journal of medicinal chemistry, Oct-15, Volume: 180	Design, synthesis and biological evaluation of 6-deoxy O-spiroketal C-arylglucosides as novel renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID1436779	Inhibition of human SGLT2 expressed in HEK293 cells assessed as reduction in 2-deoxyglucose uptake at 100 uM pretreated for 10 mins followed by 2-deoxyglucose addition in presence of sodium buffer measured after 1 hr by resazurin dye based fluorescence as	2017	Journal of medicinal chemistry, 01-26, Volume: 60, Issue:2	Targeting Type 2 Diabetes with C-Glucosyl Dihydrochalcones as Selective Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitors: Synthesis and Biological Evaluation.
AID570215	Cmax in Sprague-Dawley rat at 5 mg/kg, po after 0.67 hrs	2011	ACS medicinal chemistry letters, Feb-10, Volume: 2, Issue:2	Synthesis and SAR of Thiazolylmethylphenyl Glucoside as Novel C-Aryl Glucoside SGLT2 Inhibitors.
AID318042	Inhibition of human GLUT4-mediated 2-deoxyglucose uptake in human adipocytes at 20 uM	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID418949	Tmax in po dosed normal human at 2.5 to 500 mg/day, po administered as single ascending dose	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID444172	Inhibition of human SGLT2 transfected in HEK293.ETN cells assessed as AMG uptake after 1.5 hrs by scintillation counting	2009	Bioorganic & medicinal chemistry letters, Dec-15, Volume: 19, Issue:24	Exploration of O-spiroketal C-arylglucosides as novel and selective renal sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID466464	Inhibition of human SGLT2 expressed in CHO cells assessed as inhibition of sodium-dependent methyl-alpha-D-[U-14C]glucopyranoside uptake after 2 hrs	2010	Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5	C-Aryl glycoside inhibitors of SGLT2: Exploration of sugar modifications including C-5 spirocyclization.
AID1075134	Inhibition of full length human SGLT1 assessed as methyl-alpha-D-[U-14C]glucopyranoside uptake after 2 hrs by cell-based topcount scintillation counting analysis	2014	Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4	Design, synthesis, and biological evaluation of deuterated C-aryl glycoside as a potent and long-acting renal sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes.
AID1396976	Antihyperglycemic activity in fasting ICR mouse assessed as decrease in plasma glucose AUC (0 to 120 mins) at 2 mg/kg, po administered 30 mins prior to glucose challenge measured after 120 mins by OGTT relative to control	2018	Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14	Design, synthesis and biological evaluation of nitric oxide releasing derivatives of dapagliflozin as potential anti-diabetic and anti-thrombotic agents.
AID475705	Cmax in dog at 6.6 mg/kg, po and 6.6 mg/kg, iv	2010	Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8	(1S)-1,5-anhydro-1-[5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucitol (TS-071) is a potent, selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment.
AID1075135	Inhibition of full length human SGLT2 assessed as methyl-alpha-D-[U-14C]glucopyranoside uptake after 1.5 hrs by cell-based topcount scintillation counting analysis	2014	Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4	Design, synthesis, and biological evaluation of deuterated C-aryl glycoside as a potent and long-acting renal sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes.
AID670288	Potency index, ratio of IC50 for CYP3A4 (unknown origin) using BFC substrate in which compound added to reaction mixture simultaneously with BFC substrate to IC50 for CYP3A4 using BFC substrate in which compound added to reaction mixture before addition o	2012	Bioorganic & medicinal chemistry, Jul-01, Volume: 20, Issue:13	C-Aryl 5a-carba-β-d-glucopyranosides as novel sodium glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID1570082	Selectivity ratio of IC50 for human full length SGLT1 to IC50 for human full length SGLT2	2019	European journal of medicinal chemistry, Oct-15, Volume: 180	Design, synthesis and biological evaluation of 6-deoxy O-spiroketal C-arylglucosides as novel renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID318036	Inhibition of human SGLT2 expressed in CHO cells assessed as inhibition of [14C]AMG accumulation	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID1075108	Drug metabolism in Sprague-Dawley rat assessed as compound remaining at 50 mg/kg, po after 5 days by HPLC analysis	2014	Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4	Design, synthesis, and biological evaluation of deuterated C-aryl glycoside as a potent and long-acting renal sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes.
AID418696	Antidiabetic activity in diet-induced obese Sprague-Dawley rat assessed as weight loss at 0.5 mg/kg/day, po for 4 week relative to control	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID418961	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in fasting serum glucose level at 100 mg/day, po dosed as multiple ascending dose over 24 hrs on day 13 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1775422	Antiobesity activity in high fat diet-induced obese in Sprague-Dawley rat model assessed as increase in daily food intake at 5 mg/kg, po QD administered via gavage for 10 weeks and measured at week 2 to 7
AID1888503	AUCinfinity in Sprague-Dawley rat at 5 mg/kg, po	2022	Bioorganic & medicinal chemistry letters, 01-15, Volume: 56	Discovery of GCC5694A: A potent and selective sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes.
AID418965	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in fasting serum glucose level at 25 mg/day, po dosed as multiple ascending dose over 24 hrs on day 2 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1348753	Inhibition of human SGLT2 expressed in CHO cells assessed as reduction in [14C]AMG uptake after 1 hr by microbeta counting method	2018	European journal of medicinal chemistry, Jan-01, Volume: 143	Identification of an oxime-containing C-glucosylarene as a potential inhibitor of sodium-dependent glucose co-transporter 2.
AID1775421	Antiobesity activity in high fat diet-induced obese in Sprague-Dawley rat model assessed as increase in daily food intake at 5 mg/kg, po QD administered via gavage for 10 weeks and measured at day 8 to 56
AID554360	Selectivity ratio for EC50 for human SGLT1 to EC50 for human SGLT2 expressed in CHO cells assessed as sodium-dependent [14C]-alpha-methyl-D-glucopyranoside uptake after 2 hrs by liquid scintillation counting	2011	Journal of medicinal chemistry, Jan-13, Volume: 54, Issue:1	Discovery of novel N-β-D-xylosylindole derivatives as sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors for the management of hyperglycemia in diabetes.
AID418688	Inhibition of human kidney SGLT2 assessed as renal glucose reabsorption	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1546902	Inhibition of SGLT1 (unknown origin)	2020	Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10	The Race to Bash NASH: Emerging Targets and Drug Development in a Complex Liver Disease.
AID1888499	AUCinfinity in Sprague-Dawley rat at 1 mg/kg, iv	2022	Bioorganic & medicinal chemistry letters, 01-15, Volume: 56	Discovery of GCC5694A: A potent and selective sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes.
AID418699	Antidiabetic activity in pair-fed obese Sprague-Dawley rat assessed as increase in weight loss at 5 mg/kg, po	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID619653	Inhibition of human SGLT2 expressed in CHO cells assessed as [14C]-alpha-methyl-D-glucopyranoside uptake after 2 hrs by liquid scintillation counting	2011	Bioorganic & medicinal chemistry, Oct-01, Volume: 19, Issue:19	Novel thiophenyl C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents.
AID418972	Antidiabetic activity in type 2 diabetes mellitus patient assessed as reduction in HbA1C level at 2.5 mg, po daily measured after 12 weeks	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1396977	Antidiabetic activity in ICR mouse assessed as increase in urinary glucose excretion by measuring urine glucose levels at 2 mg/kg, po administered 30 mins prior to glucose challenge measured after 15 mins	2018	Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14	Design, synthesis and biological evaluation of nitric oxide releasing derivatives of dapagliflozin as potential anti-diabetic and anti-thrombotic agents.
AID466463	Inhibition of human SGLT1 expressed in CHO cells assessed as inhibition of sodium-dependent methyl-alpha-D-[U-14C]glucopyranoside uptake after 2 hrs	2010	Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5	C-Aryl glycoside inhibitors of SGLT2: Exploration of sugar modifications including C-5 spirocyclization.
AID441054	Inhibition of human SGLT1 expressed in african green monkey COS7 cells assessed as methyl-alpha-D-[U-14C]glucopyranoside uptake at 10 uM by scintillation counting	2009	Bioorganic & medicinal chemistry letters, Oct-01, Volume: 19, Issue:19	O-Spiro C-aryl glucosides as novel sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID318048	Reduction in blood glucose levels in streptozotocin-induced diabetic Sprague-Dawley rat at 0.03 mg/kg, po after 5 hrs	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID1436780	Inhibition of human SGLT1 expressed in HEK293 cells assessed as reduction in 2-deoxyglucose uptake at 100 uM pretreated for 10 mins followed by 2-deoxyglucose addition in presence of sodium buffer measured after 1 hr by resazurin dye based fluorescence as	2017	Journal of medicinal chemistry, 01-26, Volume: 60, Issue:2	Targeting Type 2 Diabetes with C-Glucosyl Dihydrochalcones as Selective Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitors: Synthesis and Biological Evaluation.
AID1396983	Antidiabetic activity in ICR mouse assessed as increase in urinary glucose excretion by measuring urine glucose levels at 2 mg/kg, po administered 30 mins prior to glucose challenge measured after 120 mins	2018	Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14	Design, synthesis and biological evaluation of nitric oxide releasing derivatives of dapagliflozin as potential anti-diabetic and anti-thrombotic agents.
AID1775452	Antidiabetic activity in high fat diet-induced obese Sprague-Dawley rat model assessed as reduction in plasma insulin AUC (0 to 120 mins) at 5 mg/kg, po administered for 10 weeks under HFD condition followed by overnight fasting prior to compound redosing
AID418952	Antidiabetic activity in normal human assessed as urinary glucose output 20 mg, po after 24 hrs	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1396969	Inhibition of SGLT2 (unknown origin)	2018	Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14	Design, synthesis and biological evaluation of nitric oxide releasing derivatives of dapagliflozin as potential anti-diabetic and anti-thrombotic agents.
AID418954	Toxicity in normal human assessed as adverse event incident administered as single ascending dose	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID318053	Volume of distribution at steady state in rat	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID418950	Half life in normal human at 10 to 100 mg/day, po administered as single ascending dose	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1775432	Antiobesity activity in high fat diet-induced obese Sprague-Dawley rat model assessed as reduction in HOMA-IR level at 5 mg/kg, po QD administered via gavage for 10 weeks and measured at day 58/59 relative to control
AID484634	Inhibition of human SGLT2 expressed in CHO cells assessed as [14C]alpha-methyl-D-glucopyranoside uptake after 2 hrs by liquid scintillation counting	2010	Bioorganic & medicinal chemistry letters, Jun-01, Volume: 20, Issue:11	Novel C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents: Pyridazinylmethylphenyl glucoside congeners.
AID1396970	Inhibition of human SGLT2 expressed in HEK293 cells assessed as decrease in [14C]-AMG uptake preincubated for 10 mins followed by [14C]-AMG addition and measured after 2 hrs by liquid scintillation counting method	2018	Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14	Design, synthesis and biological evaluation of nitric oxide releasing derivatives of dapagliflozin as potential anti-diabetic and anti-thrombotic agents.
AID418945	Antidiabetic activity in normal Sprague-Dawley rat assessed as urinary glucose excretion at 10 mg/kg, po after 24 hrs	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID703958	Selectivity ratio of IC50 for human SGLT1 to IC50 for human SGLT2	2012	Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17	Discovery of tofogliflozin, a novel C-arylglucoside with an O-spiroketal ring system, as a highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID1888502	Cmax in Sprague-Dawley rat at 5 mg/kg, po	2022	Bioorganic & medicinal chemistry letters, 01-15, Volume: 56	Discovery of GCC5694A: A potent and selective sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes.
AID1075130	AUC (0 to infinity) in Sprague-Dawley rat at 3 mg/kg, po by LC-MS/MS analysis	2014	Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4	Design, synthesis, and biological evaluation of deuterated C-aryl glycoside as a potent and long-acting renal sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes.
AID674702	Selectivity index, ratio of EC50 for human SGLT1 to EC50 for human SGLT2	2012	European journal of medicinal chemistry, Sep, Volume: 55	Synthesis and biological evaluation of novel C-indolylxylosides as sodium-dependent glucose co-transporter 2 inhibitors.
AID1888501	Tmax in Sprague-Dawley rat at 1 mg/kg, iv	2022	Bioorganic & medicinal chemistry letters, 01-15, Volume: 56	Discovery of GCC5694A: A potent and selective sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes.
AID670285	Selectivity index, ratio of IC50 for human SGLT1 to IC50 for human SGLT2	2012	Bioorganic & medicinal chemistry, Jul-01, Volume: 20, Issue:13	C-Aryl 5a-carba-β-d-glucopyranosides as novel sodium glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID484642	Increase of urinary volume in normal Sprague-Dawley rat at 1 mg/kg, po subsequently dosed orally with 50% aqueous glucose solution measured up to 24 hrs relative to control	2010	Bioorganic & medicinal chemistry letters, Jun-01, Volume: 20, Issue:11	Novel C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents: Pyridazinylmethylphenyl glucoside congeners.
AID318041	Inhibition of human GLUT1-mediated 2-deoxyglucose uptake in human adipocytes at 20 uM	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID475708	Oral bioavailability in dog at 6.6 mg/kg	2010	Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8	(1S)-1,5-anhydro-1-[5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucitol (TS-071) is a potent, selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment.
AID444173	Inhibition of human SGLT1 transfected in COS-7 cells assessed as AMG uptake after 2 hrs by scintillation counting	2009	Bioorganic & medicinal chemistry letters, Dec-15, Volume: 19, Issue:24	Exploration of O-spiroketal C-arylglucosides as novel and selective renal sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID1496228	Inhibition of full-length human SGLT2 expressed in CHO cells assessed as decrease in [14C]-methyl alpha-D-glucopyranoside uptake after 1 hr by liquid scintillation counting method	2018	Bioorganic & medicinal chemistry letters, 07-01, Volume: 28, Issue:12	Synthesis and biological evaluation of 6-hydroxyl C-aryl glucoside derivatives as novel sodium glucose co-transporter 2 (SGLT2) inhibitors.
AID418963	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in fasting serum glucose level at 5 mg/day, po dosed as multiple ascending dose over 24 hrs on day 13 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID418985	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in postprandial plasma glucose level at 100 mg/day, po dosed as multiple ascending dose over 24 hrs on day 13 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID418967	Antidiabetic activity in type 2 diabetes mellitus patient assessed as cumulative glucose excretion at 100 mg/day, po dosed as multiple ascending dose over 24 hrs on day 14	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1775460	Antiobesity activity in high fat diet induced obese Sprague-Dawley rat model assessed as reduction in total hepatic triglycerides concentration at 5 mg/kg, po QD for 10 weeks and measured at day 65/66 by Cobas-C111 clinical analyzer relative to control
AID674701	Inhibition of human SGLT1 expressed in CHO-K1 cells incubated for 120 mins at 37 degC by [14C]-AMG uptake assay	2012	European journal of medicinal chemistry, Sep, Volume: 55	Synthesis and biological evaluation of novel C-indolylxylosides as sodium-dependent glucose co-transporter 2 inhibitors.
AID418975	Antidiabetic activity in type 2 diabetes mellitus patient assessed as reduction in HbA1C level at 20 mg, po daily measured after 12 weeks	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID609738	Inhibition of human SGLT2 expressed in african green monkey COS7 cells assessed as inhibition of [14C]-methyl-alpha-D-glucopyranoside uptake after 2 hrs by scintillation counting in presence of 25 % human plasma	2011	Bioorganic & medicinal chemistry letters, Aug-01, Volume: 21, Issue:15	C-aryl glucosides substituted at the 4'-position as potent and selective renal sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID589967	Inhibition of human SGLT2 expressed in CHO cells assessed as inhibition of [14C]-alpha-methyl-D-glucopyranoside transport after 60 mins by scintillation counting	2011	Bioorganic & medicinal chemistry letters, Apr-15, Volume: 21, Issue:8	Discovery of non-glucoside SGLT2 inhibitors.
AID418964	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in fasting serum glucose level at 100 mg/day, po dosed as multiple ascending dose over 24 hrs on day 2 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID443606	Selectivity for human SGLT2 over human SGLT1	2009	Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20	Novel L-xylose derivatives as selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID441052	Selectivity ratio of IC50 for human SGLT1 to IC50 for human SGLT2	2009	Bioorganic & medicinal chemistry letters, Oct-01, Volume: 19, Issue:19	O-Spiro C-aryl glucosides as novel sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID418974	Antidiabetic activity in type 2 diabetes mellitus patient assessed as reduction in HbA1C level at 10 mg, po daily measured after 12 weeks	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID418957	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in postprandial plasma glucose level at 5 mg/day, po dosed as multiple ascending dose over 24 hrs on day 13 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID418691	Selectivity for rat SGLT1 over rat SGLT2	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1447832	Inhibition of human SGLT1 expressed in CHO cells assessed as decrease in uptake of [14C]AMG after 120 mins by TopCount method	2017	Journal of medicinal chemistry, 05-25, Volume: 60, Issue:10	Discovery of a Potent, Selective Renal Sodium-Dependent Glucose Cotransporter 2 (SGLT2) Inhibitor (HSK0935) for the Treatment of Type 2 Diabetes.
AID1775429	Antiobesity activity in high fat diet-induced obese Sprague-Dawley rat model assessed as plasma insulin level at 5 mg/kg, po QD administered via gavage for 10 weeks and measured at day 51 (Rvb = 54.8 %)
AID466470	Half life in Sprague-Dawley rat at 2 mg/kg, iv	2010	Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5	C-Aryl glycoside inhibitors of SGLT2: Exploration of sugar modifications including C-5 spirocyclization.
AID1775453	Protection in high fat diet induced obese Sprague-Dawley rat model assessed as increase in liver weight at 5 mg/kg, po QD for 10 weeks and measured at day 65/66 by H and E and Masson's trichrome staining based histological analysis
AID318038	Selectivity for human SGLT2 over human SGLT1	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID418983	Antidiabetic activity in normal human assessed as reduction urinary glucose excretion at 5 mg, po after 24 hrs	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1348754	Inhibition of human SGLT1 expressed in CHO cells assessed as reduction in [14C]AMG uptake after 1 hr by microbeta counting method	2018	European journal of medicinal chemistry, Jan-01, Volume: 143	Identification of an oxime-containing C-glucosylarene as a potential inhibitor of sodium-dependent glucose co-transporter 2.
AID674700	Inhibition of human SGLT2 expressed in CHO-K1 cells incubated for 120 mins at 37 degC by [14C]-AMG uptake assay	2012	European journal of medicinal chemistry, Sep, Volume: 55	Synthesis and biological evaluation of novel C-indolylxylosides as sodium-dependent glucose co-transporter 2 inhibitors.
AID318056	Elimination half life in intra arterially dosed rat	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID670287	Inhibition of CYP3A4 using BFC substrate in which compound added to reaction mixture before addition of BFC substrate by fluorometric assay	2012	Bioorganic & medicinal chemistry, Jul-01, Volume: 20, Issue:13	C-Aryl 5a-carba-β-d-glucopyranosides as novel sodium glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID418693	Antidiabetic activity in normal Sprague-Dawley rat assessed as reduction in glucose AUC at 10 mg/kg, po by OGTT	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID614528	Inhibition of human SGLT2 expressed in CHO cells assessed as reduction of [14C]-labeled AMG after 2 hrs by liquid scintillation counting	2011	Bioorganic & medicinal chemistry, Sep-15, Volume: 19, Issue:18	Novel macrocyclic C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents.
AID1075129	Half life in Sprague-Dawley rat at 3 mg/kg, po by LC-MS/MS analysis	2014	Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4	Design, synthesis, and biological evaluation of deuterated C-aryl glycoside as a potent and long-acting renal sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes.
AID418698	Antidiabetic activity in diet-induced obese Sprague-Dawley rat assessed as weight loss at 5 mg/kg/day, po for 4 week relative to control	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID318037	Inhibition of human SGLT1 expressed in CHO cells assessed as inhibition of [14C]AMG accumulation	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID1546223	Inhibition of human SGLT2	2019	European journal of medicinal chemistry, Dec-15, Volume: 184	Synthetic strategy and SAR studies of C-glucoside heteroaryls as SGLT2 inhibitor: A review.
AID1291381	Inhibition of human SGLT2 expressed in CHO cells assessed as reduction in [14C]AMG uptake at 10 uM after 1 hr by liquid scintillation counting method relative to control	2016	European journal of medicinal chemistry, May-23, Volume: 114	Synthesis and biological evaluation of novel tetrahydroisoquinoline-C-aryl glucosides as SGLT2 inhibitors for the treatment of type 2 diabetes.
AID1153750	Inhibition of human SGLT1 expressed in CHOK1 cells assessed as inhibition of [14C]-AMG uptake after 3 hrs by microbeta scintillation counting analysis	2014	Bioorganic & medicinal chemistry, Jul-01, Volume: 22, Issue:13	The design and synthesis of novel SGLT2 inhibitors: C-glycosides with benzyltriazolopyridinone and phenylhydantoin as the aglycone moieties.
AID318059	Induction of glucosuria in Sprague-Dawley rat assessed as glucose loss per 200 gm of body weight at 10 mg/kg after 24 hrs	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID418701	Antidiabetic activity in diet-induced obese Sprague-Dawley rat assessed as increase in 3-butyrate level at 1 mg, po after 28 days	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1570080	Inhibition of human full length SGLT1 expressed in NIH3T3 cells measured after 1 hr in presence of [14C]-methyl-alpha -D-glucopyranoside by scintillation counter method	2019	European journal of medicinal chemistry, Oct-15, Volume: 180	Design, synthesis and biological evaluation of 6-deoxy O-spiroketal C-arylglucosides as novel renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID441053	Inhibition of human SGLT2 expressed in HEK293.ETN cells assessed as methyl-alpha-D-[U-14C]glucopyranoside uptake at 10 nM by scintillation counting	2009	Bioorganic & medicinal chemistry letters, Oct-01, Volume: 19, Issue:19	O-Spiro C-aryl glucosides as novel sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID418959	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in postprandial plasma glucose level at 25 mg/day, po dosed as multiple ascending dose over 24 hrs on day 2 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID318052	Oral bioavailability in rat	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID1775468	Anti-hepatosteatosis activity in high fat diet induced obese Sprague-Dawley rat model assessed as increase in steatosis score at 5 mg/kg, po QD for 10 weeks and measured at day 65/66 by H and E and Masson's trichrome staining based histological analysis
AID1775446	Antidiabetic activity in high fat diet-induced obese Sprague-Dawley rat model assessed as reduction in plasma glucose level at 5 mg/kg, po administered for 10 weeks under HFD condition followed by overnight fasting prior to compound redosing on day 58/59
AID318057	Elimination half life in intra arterially dosed dog	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID1396979	Antidiabetic activity in ICR mouse assessed as increase in urinary glucose excretion by measuring urine glucose levels at 2 mg/kg, po administered 30 mins prior to glucose challenge measured after 30 mins	2018	Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14	Design, synthesis and biological evaluation of nitric oxide releasing derivatives of dapagliflozin as potential anti-diabetic and anti-thrombotic agents.
AID1775418	Antiobesity activity in high fat diet-induced obese in Sprague-Dawley rat model assessed as decrease in body weight at 5 mg/kg, po QD administered via gavage for 10 weeks and measured at week 1
AID418960	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in postprandial plasma glucose level at 5 mg/day, po dosed as multiple ascending dose over 24 hrs on day 2 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1447842	Antidiabetic activity in rhesus monkey assessed as increase in urinary glucose excrection at 25 mg/kg, po administered as single dose 30 mins prior to glucose challenge and subsequent re-feeding after 1 hr of glucose challenge measured after 4 to 5 days	2017	Journal of medicinal chemistry, 05-25, Volume: 60, Issue:10	Discovery of a Potent, Selective Renal Sodium-Dependent Glucose Cotransporter 2 (SGLT2) Inhibitor (HSK0935) for the Treatment of Type 2 Diabetes.
AID1775428	Antiobesity activity in high fat diet-induced obese Sprague-Dawley rat model assessed as plasma glucose level at 5 mg/kg, po QD administered via gavage for 10 weeks and measured at day 51 (Rvb = 17.3 %)
AID466465	Selectivity ratio of IC50 for human SGLT2 over IC50 for human SGLT1	2010	Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5	C-Aryl glycoside inhibitors of SGLT2: Exploration of sugar modifications including C-5 spirocyclization.
AID609769	Selectivity ratio of IC50 for human SGLT1 to IC50 for human SGLT2	2011	Bioorganic & medicinal chemistry letters, Aug-01, Volume: 21, Issue:15	C-aryl glucosides substituted at the 4'-position as potent and selective renal sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID497192	Inhibition of human SGLT2	2010	Bioorganic & medicinal chemistry, Aug-15, Volume: 18, Issue:16	Synthesis of pyridazine and thiazole analogs as SGLT2 inhibitors.
AID614529	Antidiabetic activity in Sprague-Dawley rat assessed as induction of urinary glucose excretion per 200 gram of body weight at 1 mg/kg, po	2011	Bioorganic & medicinal chemistry, Sep-15, Volume: 19, Issue:18	Novel macrocyclic C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents.
AID418703	Antidiabetic activity in normal Sprague-Dawley rat assessed as urinary glucose excretion at 0.1 mg/kg, po after 24 hrs	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1348784	Antihyperglycemic activity in streptozotocin-induced diabetic Sprague-Dawley rat model assessed as reduction in blood glucose level at 10 mg/kg, po administered as single dose measured after 5 hrs	2018	European journal of medicinal chemistry, Jan-01, Volume: 143	Identification of an oxime-containing C-glucosylarene as a potential inhibitor of sodium-dependent glucose co-transporter 2.
AID418968	Antidiabetic activity in type 2 diabetes mellitus patient assessed as cumulative glucose excretion at 25 mg/day, po dosed as multiple ascending dose over 24 hrs on day 14	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID484638	Cmax in Sprague-Dawley rat at 5 mg/kg, po after 0.67 hrs	2010	Bioorganic & medicinal chemistry letters, Jun-01, Volume: 20, Issue:11	Novel C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents: Pyridazinylmethylphenyl glucoside congeners.
AID418953	Antidiabetic activity in normal human assessed as complete glucose output 50 mg, po after 24 hrs	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID318051	Permeability across human Caco-2 cells	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID551417	Inhibition of human SGLT2 expressed in CHO cells assessed as inhibition of [14C]alpha-methyl-D-glucopyranoside uptake after 2 hrs by liquid scintillation counting	2011	Bioorganic & medicinal chemistry letters, Jan-15, Volume: 21, Issue:2	Exploration of SAR regarding glucose moiety in novel C-aryl glucoside inhibitors of SGLT2.
AID318055	Clearance in rat at 1 mg/kg, po after 1.7 hrs	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID484641	Increase of urinary glucose excretion in normal Sprague-Dawley rat assessed per 200 g of body weight at 1 mg/kg, po subsequently dosed orally with 50% aqueous glucose solution measured up to 24 hrs (RVB = 1.90 +/- 228 mg/200 g of body weight)	2010	Bioorganic & medicinal chemistry letters, Jun-01, Volume: 20, Issue:11	Novel C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents: Pyridazinylmethylphenyl glucoside congeners.
AID554361	Inhibition of human SGLT2 expressed in CHO cells assessed as sodium-dependent [14C]-alpha-methyl-D-glucopyranoside uptake after 2 hrs by liquid scintillation counting	2011	Journal of medicinal chemistry, Jan-13, Volume: 54, Issue:1	Discovery of novel N-β-D-xylosylindole derivatives as sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors for the management of hyperglycemia in diabetes.
AID418697	Antidiabetic activity in diet-induced obese Sprague-Dawley rat assessed as weight loss at 1 mg/kg/day, po for 4 week relative to control	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID418702	Antidiabetic activity in diet-induced obese Sprague-Dawley rat assessed as increase in 3-butyrate level at 5 mg, po after 28 days	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1075106	Drug metabolism in Sprague-Dawley rat assessed as (2S,3R,4R,5S,6R)-2-(4-Chloro-3-(4-hydroxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol formation at 50 mg/kg, po after 5 days by HPLC analysis	2014	Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4	Design, synthesis, and biological evaluation of deuterated C-aryl glycoside as a potent and long-acting renal sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes.
AID670286	Inhibition of CYP3A4 using BFC substrate in which compound added to reaction mixture simultaneously with BFC substrate by fluorometric assay	2012	Bioorganic & medicinal chemistry, Jul-01, Volume: 20, Issue:13	C-Aryl 5a-carba-β-d-glucopyranosides as novel sodium glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID589976	Inhibition of SGLT6 expressed in CHO cells assessed as inhibition of [14C]-alpha-methyl-D-glucopyranoside transport after 60 mins by scintillation counting	2011	Bioorganic & medicinal chemistry letters, Apr-15, Volume: 21, Issue:8	Discovery of non-glucoside SGLT2 inhibitors.
AID487640	Inhibition of human SGLT1 expressed in african green monkey COS7 cells assessed as inhibition of [14C]alpha-methyl-D-glucopyranoside uptake after 2 hrs by liquid scintillation counting	2010	Bioorganic & medicinal chemistry, Jun-15, Volume: 18, Issue:12	ortho-Substituted C-aryl glucosides as highly potent and selective renal sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID1396972	Selectivity ratio of IC50 for human SGLT1 expressed in HEK293 cells to IC50 for human SGLT2 expressed in HEK293 cells	2018	Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14	Design, synthesis and biological evaluation of nitric oxide releasing derivatives of dapagliflozin as potential anti-diabetic and anti-thrombotic agents.
AID598854	Inhibition of human SGLT2 expressed in CHO cells assessed as inhibition of [14C]-Glucose uptake using [14C]-methyl glucopyranoside after 60 mins by microbeta plate counting	2011	Bioorganic & medicinal chemistry letters, Jun-15, Volume: 21, Issue:12	Optimization of triazoles as novel and potent nonphlorizin SGLT2 inhibitors.
AID418956	Toxicity in normal human assessed as adverse event incident administered as multiple ascending dose	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID462927	Effect on urine volume in normal fasted Sprague-Dawley rat at 1 mg/kg, po subsequently co-treated with glucose measured up to 24 hrs relative to untreated control	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Novel C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents: 1,3,4-Thiadiazolylmethylphenyl glucoside congeners.
AID475707	Half life in dog at 6.6 mg/kg, po and 6.6 mg/kg, iv	2010	Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8	(1S)-1,5-anhydro-1-[5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucitol (TS-071) is a potent, selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment.
AID318043	Induction of glucosuria in po dosed Sprague-Dawley rat after 24 hrs	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID638440	Antidiabetic activity in fasted Sprague-Dawley rat assessed as increase in urinary glucose excretion at 30 mg/kg, po administered 0.5 hrs before glucose challenge measured after 24 hrs by UV spectrophotometric analysis relative to control	2012	Bioorganic & medicinal chemistry letters, Jan-01, Volume: 22, Issue:1	Facile synthesis of 1,2,3-triazole analogs of SGLT2 inhibitors by 'click chemistry'.
AID475706	Tmax in dog at 6.6 mg/kg, po and 6.6 mg/kg, iv	2010	Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8	(1S)-1,5-anhydro-1-[5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucitol (TS-071) is a potent, selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment.
AID1447833	Selectivity ratio of IC50 for human SGLT1 expressed in CHO cells to IC50 for human SGLT2 expressed in CHO cells	2017	Journal of medicinal chemistry, 05-25, Volume: 60, Issue:10	Discovery of a Potent, Selective Renal Sodium-Dependent Glucose Cotransporter 2 (SGLT2) Inhibitor (HSK0935) for the Treatment of Type 2 Diabetes.
AID570214	Oral bioavailability in Sprague-Dawley rat at 5 mg/kg	2011	ACS medicinal chemistry letters, Feb-10, Volume: 2, Issue:2	Synthesis and SAR of Thiazolylmethylphenyl Glucoside as Novel C-Aryl Glucoside SGLT2 Inhibitors.
AID670283	Inhibition of human SGLT2 expressed in CHO-K1 cells by [14C]AMG uptake assay	2012	Bioorganic & medicinal chemistry, Jul-01, Volume: 20, Issue:13	C-Aryl 5a-carba-β-d-glucopyranosides as novel sodium glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID1775470	Anti-hepatosteatosis activity in high fat diet induced obese Sprague-Dawley rat model assessed as increase in ballooning score at 5 mg/kg, po QD for 10 weeks and measured at day 65/66 by H and E and Masson's trichrome staining based histological analysis
AID570213	Elimination half life in Sprague-Dawley rat at 5 mg/kg, po	2011	ACS medicinal chemistry letters, Feb-10, Volume: 2, Issue:2	Synthesis and SAR of Thiazolylmethylphenyl Glucoside as Novel C-Aryl Glucoside SGLT2 Inhibitors.
AID444174	Selectivity ratio, IC50 for human recombinant SGLT2 to IC50 for human recombinant SGLT1	2009	Bioorganic & medicinal chemistry letters, Dec-15, Volume: 19, Issue:24	Exploration of O-spiroketal C-arylglucosides as novel and selective renal sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID1192797	Competitive inhibition of full-length human SGLT2 expressed in CHO cells assessed as inhibition of sodium-dependent [14C]-alpha-methyl-D-glucopyranoside uptake after 2 hrs by scintillation counting	2015	Bioorganic & medicinal chemistry letters, Mar-01, Volume: 25, Issue:5	Transporter-mediated tissue targeting of therapeutic molecules in drug discovery.
AID538620	Inhibition of human SGLT2 assessed as inhibition of methyl-alpha-D-glucopyranoside uptake by cell based assay	2010	Bioorganic & medicinal chemistry letters, Dec-01, Volume: 20, Issue:23	Pyrimidinylmethylphenyl glucoside as novel C-aryl glucoside SGLT2 inhibitors.
AID1888505	Tmax in Sprague-Dawley rat at 5 mg/kg, po	2022	Bioorganic & medicinal chemistry letters, 01-15, Volume: 56	Discovery of GCC5694A: A potent and selective sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes.
AID1775430	Antiobesity activity in high fat diet-induced obese Sprague-Dawley rat model assessed as HOMA-IR level at 5 mg/kg, po QD administered via gavage for 10 weeks and measured at day 51 (Rvb = 78.4 %)
AID599006	Inhibition of human SGLT2 expressed in CHO cells using methyl-alpha-D-glucopyranoside by liquid scintillation counting	2011	Bioorganic & medicinal chemistry letters, Jun-15, Volume: 21, Issue:12	Glucosides with cyclic diarylpolynoid as novel C-aryl glucoside SGLT2 inhibitors.
AID1153749	Inhibition of human SGLT2 expressed in CHOK1 cells assessed as inhibition of [14C]-AMG uptake after 3 hrs by microbeta scintillation counting analysis	2014	Bioorganic & medicinal chemistry, Jul-01, Volume: 22, Issue:13	The design and synthesis of novel SGLT2 inhibitors: C-glycosides with benzyltriazolopyridinone and phenylhydantoin as the aglycone moieties.
AID418958	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in postprandial plasma glucose level at 100 mg/day, po dosed as multiple ascending dose over 24 hrs on day 2 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID418689	Selectivity for human SGLT2 over human SGLT1	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID418947	Antidiabetic activity in normal Sprague-Dawley rat assessed as urinary glucose excretion at 100 mg/kg, po after 24 hrs	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1436777	Inhibition of human SGLT2 expressed in HEK293 cells assessed as reduction in 2-deoxyglucose uptake pretreated for 10 mins followed by 2-deoxyglucose addition in presence of sodium buffer measured after 1 hr by resazurin dye based fluorescence assay	2017	Journal of medicinal chemistry, 01-26, Volume: 60, Issue:2	Targeting Type 2 Diabetes with C-Glucosyl Dihydrochalcones as Selective Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitors: Synthesis and Biological Evaluation.
AID418984	Antidiabetic activity in normal human assessed as reduction urinary glucose excretion at 20 mg, po after 24 hrs	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID484636	Elimination half life in Sprague-Dawley rat at 5 mg/kg, po	2010	Bioorganic & medicinal chemistry letters, Jun-01, Volume: 20, Issue:11	Novel C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents: Pyridazinylmethylphenyl glucoside congeners.
AID441048	Inhibition of human SGLT2 expressed in HEK293.ETN cells assessed as methyl-alpha-D-[U-14C]glucopyranoside uptake by scintillation counting	2009	Bioorganic & medicinal chemistry letters, Oct-01, Volume: 19, Issue:19	O-Spiro C-aryl glucosides as novel sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID1546903	Inhibition of SGLT2 (unknown origin)	2020	Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10	The Race to Bash NASH: Emerging Targets and Drug Development in a Complex Liver Disease.
AID418955	Antidiabetic activity in normal human assessed as reduction of complete glucose output 2.5 mg, po after 24 hrs	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1546210	Antidiabetic activity in human assessed as reduction in HbA1c level at 5 to 10 mg, po relative to control	2019	European journal of medicinal chemistry, Dec-15, Volume: 184	Synthetic strategy and SAR studies of C-glucoside heteroaryls as SGLT2 inhibitor: A review.
AID418704	Antidiabetic activity in normal Sprague-Dawley rat assessed as urinary glucose excretion at 1 mg/kg, po after 24 hrs	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1888504	Terminal elimination half life in Sprague-Dawley rat at 5 mg/kg, po	2022	Bioorganic & medicinal chemistry letters, 01-15, Volume: 56	Discovery of GCC5694A: A potent and selective sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes.
AID418962	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in fasting serum glucose level at 25 mg/day, po dosed as multiple ascending dose over 24 hrs on day 13 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1888498	Cmax in Sprague-Dawley rat at 1 mg/kg, iv	2022	Bioorganic & medicinal chemistry letters, 01-15, Volume: 56	Discovery of GCC5694A: A potent and selective sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes.
AID418695	Antidiabetic activity in ZDF rat assessed as postprandial plasma glucose level at 1 mg/kg/day, po for 15 days	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID418976	Antidiabetic activity in type 2 diabetes mellitus patient assessed as reduction in HbA1C level at 50 mg, po daily measured after 12 weeks	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID418971	Antidiabetic activity in type 2 diabetes mellitus patient assessed as cumulative glucose excretion at 25 mg/day, po dosed as multiple ascending dose over 24 hrs on day 1	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID601552	Inhibition of human SGLT2 expressed in CHO cells assessed as [14C]-alpha-methyl-D-glucopyranoside uptake after 2 hrs by liquid scintillation counter	2011	European journal of medicinal chemistry, Jul, Volume: 46, Issue:7	Thiazolylmethyl ortho-substituted phenyl glucoside library as novel C-aryl glucoside SGLT2 inhibitors.
AID487637	Inhibition of human SGLT2 expressed in HEK293 cells assessed as inhibition of [14C]alpha-methyl-D-glucopyranoside uptake after 1.5 hrs by liquid scintillation counting	2010	Bioorganic & medicinal chemistry, Jun-15, Volume: 18, Issue:12	ortho-Substituted C-aryl glucosides as highly potent and selective renal sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID1396971	Inhibition of human SGLT1 expressed in HEK293 cells assessed as decrease in [14C]-AMG uptake preincubated for 10 mins followed by [14C]-AMG addition and measured after 2 hrs by liquid scintillation counting method	2018	Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14	Design, synthesis and biological evaluation of nitric oxide releasing derivatives of dapagliflozin as potential anti-diabetic and anti-thrombotic agents.
AID418692	Antidiabetic activity in normal Sprague-Dawley rat assessed as reduction in glucose AUC at 1 mg/kg, po by OGTT	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1396981	Antidiabetic activity in ICR mouse assessed as increase in urinary glucose excretion by measuring urine glucose levels at 2 mg/kg, po administered 30 mins prior to glucose challenge measured after 60 mins	2018	Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14	Design, synthesis and biological evaluation of nitric oxide releasing derivatives of dapagliflozin as potential anti-diabetic and anti-thrombotic agents.
AID1888500	Terminal elimination half life in Sprague-Dawley rat at 1 mg/kg, iv	2022	Bioorganic & medicinal chemistry letters, 01-15, Volume: 56	Discovery of GCC5694A: A potent and selective sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes.
AID1075131	Cmax in Sprague-Dawley rat at 3 mg/kg, po by LC-MS/MS analysis	2014	Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4	Design, synthesis, and biological evaluation of deuterated C-aryl glycoside as a potent and long-acting renal sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes.
AID318046	Reduction in blood glucose levels in streptozotocin-induced diabetic Sprague-Dawley rat at 0.1 mg/kg, po after 5 hrs	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID475710	Clearance in dog at 6.6 mg/kg, po and 6.6 mg/kg, iv	2010	Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8	(1S)-1,5-anhydro-1-[5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucitol (TS-071) is a potent, selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment.
AID418681	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in postprandial plasma glucose level at 25 mg/day, po dosed as multiple ascending dose over 24 hrs on day 13 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID475709	Volume of distribution at steady state in dog at 6.6 mg/kg, po and 6.6 mg/kg, iv	2010	Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8	(1S)-1,5-anhydro-1-[5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl]-1-thio-D-glucitol (TS-071) is a potent, selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes treatment.
AID570210	Antidiabetic activity in Sprague-Dawley rat assessed as increase of urine volume at 1 mg/kg, po relative to control	2011	ACS medicinal chemistry letters, Feb-10, Volume: 2, Issue:2	Synthesis and SAR of Thiazolylmethylphenyl Glucoside as Novel C-Aryl Glucoside SGLT2 Inhibitors.
AID466473	Antidiabetic activity in Sprague-Dawley rat assessed as maximum urinary glucose excretion at 10 mg/kg, po over 24 hrs measured per 200 g body weight	2010	Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5	C-Aryl glycoside inhibitors of SGLT2: Exploration of sugar modifications including C-5 spirocyclization.
AID1888506	Oral bioavailability in Sprague-Dawley rat at 5 mg/kg	2022	Bioorganic & medicinal chemistry letters, 01-15, Volume: 56	Discovery of GCC5694A: A potent and selective sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes.
AID1447831	Inhibition of human SGLT2 expressed in CHO cells assessed as decrease in uptake of [14C]AMG after 120 mins by TopCount method	2017	Journal of medicinal chemistry, 05-25, Volume: 60, Issue:10	Discovery of a Potent, Selective Renal Sodium-Dependent Glucose Cotransporter 2 (SGLT2) Inhibitor (HSK0935) for the Treatment of Type 2 Diabetes.
AID1775431	Antiobesity activity in high fat diet-induced obese Sprague-Dawley rat model assessed as reduction in plasma glucose level at 5 mg/kg, po QD administered via gavage for 10 weeks and measured at day 58/59
AID1546232	Selectivity ratio of IC50 for inhibition of human SGLT1 to IC50 for inhibition of human SGLT2	2019	European journal of medicinal chemistry, Dec-15, Volume: 184	Synthetic strategy and SAR studies of C-glucoside heteroaryls as SGLT2 inhibitor: A review.
AID443605	Inhibition of human SGLT1 expressed in HEK293 cells assessed as inhibition of [14C]alpha-methylglucopyranoside uptake	2009	Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20	Novel L-xylose derivatives as selective sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID318039	Inhibition of rat SGLT2 expressed in CHO cells assessed as inhibition of [14C]AMG accumulation	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID466472	Oral bioavailability in Sprague-Dawley rat at 5 mg/kg	2010	Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5	C-Aryl glycoside inhibitors of SGLT2: Exploration of sugar modifications including C-5 spirocyclization.
AID1546222	Inhibition of human SGLT1	2019	European journal of medicinal chemistry, Dec-15, Volume: 184	Synthetic strategy and SAR studies of C-glucoside heteroaryls as SGLT2 inhibitor: A review.
AID1076412	Inhibition of human SGLT2	2014	Bioorganic & medicinal chemistry letters, Mar-15, Volume: 24, Issue:6	Synthesis of novel l-rhamnose derived acyclic C-nucleosides with substituted 1,2,3-triazole core as potent sodium-glucose co-transporter (SGLT) inhibitors.
AID1075132	Tmax in Sprague-Dawley rat at 3 mg/kg, po by LC-MS/MS analysis	2014	Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4	Design, synthesis, and biological evaluation of deuterated C-aryl glycoside as a potent and long-acting renal sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes.
AID1436776	Inhibition of human SGLT1 expressed in HEK293 cells assessed as reduction in 2-deoxyglucose uptake pretreated for 10 mins followed by 2-deoxyglucose addition in presence of sodium buffer measured after 1 hr by resazurin dye based fluorescence assay	2017	Journal of medicinal chemistry, 01-26, Volume: 60, Issue:2	Targeting Type 2 Diabetes with C-Glucosyl Dihydrochalcones as Selective Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitors: Synthesis and Biological Evaluation.
AID703959	Inhibition of human SGLT1 expressed in CHO cells assessed as inhibition of sodium-dependent [14C]methyl-alpha-D-glucopyranoside uptake after 45 mins	2012	Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17	Discovery of tofogliflozin, a novel C-arylglucoside with an O-spiroketal ring system, as a highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID418973	Antidiabetic activity in type 2 diabetes mellitus patient assessed as reduction in HbA1C level at 5 mg, po daily measured after 12 weeks	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1496229	Inhibition of full-length human SGLT2 expressed in CHO cells assessed as decrease in [14C]-methyl alpha-D-glucopyranoside uptake at 0.5 uM after 1 hr by liquid scintillation counting method	2018	Bioorganic & medicinal chemistry letters, 07-01, Volume: 28, Issue:12	Synthesis and biological evaluation of 6-hydroxyl C-aryl glucoside derivatives as novel sodium glucose co-transporter 2 (SGLT2) inhibitors.
AID318058	Elimination half life in intra arterially dosed monkey	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID554362	Inhibition of human SGLT1 expressed in CHO cells assessed as sodium-dependent [14C]-alpha-methyl-D-glucopyranoside uptake after 2 hrs by liquid scintillation counting	2011	Journal of medicinal chemistry, Jan-13, Volume: 54, Issue:1	Discovery of novel N-β-D-xylosylindole derivatives as sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors for the management of hyperglycemia in diabetes.
AID703960	Inhibition of human SGLT2 expressed in CHO cells assessed as inhibition of sodium-dependent [14C]methyl-alpha-D-glucopyranoside uptake after 45 mins	2012	Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17	Discovery of tofogliflozin, a novel C-arylglucoside with an O-spiroketal ring system, as a highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID1075133	Selectivity ratio of IC50 for human SGLT2 to IC50 for human SGLT1	2014	Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4	Design, synthesis, and biological evaluation of deuterated C-aryl glycoside as a potent and long-acting renal sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes.
AID484645	Increase of urinary volume in normal Sprague-Dawley rat assessed per 200 mg of body weight at 10 mg/kg, po subsequently dosed orally with 50% aqueous glucose solution measured up to 24 hrs (RVB = 3.9 +/- 0.23 ml/200 mg body weight)	2010	Bioorganic & medicinal chemistry letters, Jun-01, Volume: 20, Issue:11	Novel C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents: Pyridazinylmethylphenyl glucoside congeners.
AID462924	Inhibition of human recombinant SGLT2 expressed in CHO cells by liquid scintillation counting	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Novel C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents: 1,3,4-Thiadiazolylmethylphenyl glucoside congeners.
AID1775447	Antidiabetic activity in high fat diet-induced obese Sprague-Dawley rat model assessed as reduction in plasma glucose level at 5 mg/kg, po administered for 10 weeks under HFD condition followed by overnight fasting prior to compound redosing on day 58/59
AID418700	Antidiabetic activity in diet-induced obese Sprague-Dawley rat assessed as increase in 3-butyrate level at 0.5 mg, po after 28 days	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID609739	Inhibition of human SGLT1 expressed in human 293 cells assessed as inhibition of [14C]-methyl-alpha-D-glucopyranoside uptake after 1.5 hrs by scintillation counting in presence of 25 % human plasma	2011	Bioorganic & medicinal chemistry letters, Aug-01, Volume: 21, Issue:15	C-aryl glucosides substituted at the 4'-position as potent and selective renal sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID1075107	Drug metabolism in Sprague-Dawley rat assessed as (2S,3R,4R,5S,6R)-2-(4-chloro-3-((4-ethoxyphenyl)(hydroxy)methyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol formation at 50 mg/kg, po after 5 days by HPLC analysis	2014	Journal of medicinal chemistry, Feb-27, Volume: 57, Issue:4	Design, synthesis, and biological evaluation of deuterated C-aryl glycoside as a potent and long-acting renal sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes.
AID418966	Antidiabetic activity in type 2 diabetes mellitus patient assessed as decrease in fasting serum glucose level at 5 mg/day, po dosed as multiple ascending dose over 24 hrs on day 2 relative to baseline	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID466466	Clearance in Sprague-Dawley rat at 2 mg/kg, iv	2010	Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5	C-Aryl glycoside inhibitors of SGLT2: Exploration of sugar modifications including C-5 spirocyclization.
AID484637	Oral bioavailability in Sprague-Dawley rat at 5 mg/kg	2010	Bioorganic & medicinal chemistry letters, Jun-01, Volume: 20, Issue:11	Novel C-aryl glucoside SGLT2 inhibitors as potential antidiabetic agents: Pyridazinylmethylphenyl glucoside congeners.
AID589968	Inhibition of human SGLT1 expressed in CHO cells assessed as inhibition of [14C]-alpha-methyl-D-glucopyranoside transport after 60 mins by scintillation counting	2011	Bioorganic & medicinal chemistry letters, Apr-15, Volume: 21, Issue:8	Discovery of non-glucoside SGLT2 inhibitors.
AID418951	Clearance in normal human at 10 to 100 mg/day, po administered as single ascending dose	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1775450	Antidiabetic activity in high fat diet-induced obese Sprague-Dawley rat model assessed as reduction in plasma insulin AUC (0 to 60 mins) at 5 mg/kg, po administered for 10 weeks under HFD condition followed by overnight fasting prior to compound redosing
AID418986	Antidiabetic activity in type 2 diabetes mellitus patient assessed as cumulative glucose excretion at 5 mg/day, po dosed as multiple ascending dose over 24 hrs on day 1	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID466468	Volume of distribution at steady state in Sprague-Dawley rat at 2 mg/kg, iv	2010	Bioorganic & medicinal chemistry letters, Mar-01, Volume: 20, Issue:5	C-Aryl glycoside inhibitors of SGLT2: Exploration of sugar modifications including C-5 spirocyclization.
AID318047	Reduction in blood glucose levels in streptozotocin-induced diabetic Sprague-Dawley rat at 0.01 mg/kg, po after 5 hrs	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID318045	Induction of glucosuria in Sprague-Dawley rat assessed as glucose loss per 200 gm of body weight at 1.0 mg/kg after 24 hrs	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID441050	Inhibition of human SGLT1 expressed in african green monkey COS7 cells assessed as methyl-alpha-D-[U-14C]glucopyranoside uptake by scintillation counting	2009	Bioorganic & medicinal chemistry letters, Oct-01, Volume: 19, Issue:19	O-Spiro C-aryl glucosides as novel sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID1775469	Anti-hepatosteatosis activity in high fat diet induced obese Sprague-Dawley rat model assessed as increase in lobular inflammation score at 5 mg/kg, po QD for 10 weeks and measured at day 65/66 by H and E and Masson's trichrome staining based histological
AID418694	Antidiabetic activity in ZDF rat assessed as fasting plasma glucose level at 1 mg/kg/day, po for 15 days	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1436778	Selectivity ratio of IC50 for human SGLT1 to IC50 for human SGLT2	2017	Journal of medicinal chemistry, 01-26, Volume: 60, Issue:2	Targeting Type 2 Diabetes with C-Glucosyl Dihydrochalcones as Selective Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitors: Synthesis and Biological Evaluation.
AID418969	Antidiabetic activity in type 2 diabetes mellitus patient assessed as cumulative glucose excretion at 5 mg/day, po dosed as multiple ascending dose over 24 hrs on day 14	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID318044	Induction of glucosuria in Sprague-Dawley rat assessed as glucose loss per 200 gm of body weight at 0.1 mg/kg after 24 hrs	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID418970	Antidiabetic activity in type 2 diabetes mellitus patient assessed as cumulative glucose excretion at 100 mg/day, po dosed as multiple ascending dose over 24 hrs on day 1	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID1775451	Antidiabetic activity in high fat diet-induced obese Sprague-Dawley rat model assessed as reduction in plasma glucose AUC (0 to 120 mins) at 5 mg/kg, po administered for 10 weeks under HFD condition followed by overnight fasting prior to compound redosing
AID418690	Inhibition of rat SGLT2	2009	Journal of medicinal chemistry, Apr-09, Volume: 52, Issue:7	Development of the renal glucose reabsorption inhibitors: a new mechanism for the pharmacotherapy of diabetes mellitus type 2.
AID318054	Cmax in rat at 1 mg/kg, po after 1.7 hrs	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID318040	Selectivity for rat SGLT2 over rat SGLT1	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID318050	Fraction unbound in human serum at 10 uM	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID318049	Fraction unbound in rat serum at 10 uM	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID670284	Inhibition of human SGLT1 expressed in CHO-K1 cells by [14C]AMG uptake assay	2012	Bioorganic & medicinal chemistry, Jul-01, Volume: 20, Issue:13	C-Aryl 5a-carba-β-d-glucopyranosides as novel sodium glucose cotransporter 2 (SGLT2) inhibitors for the treatment of type 2 diabetes.
AID1888489	Inhibition of human SGLT2 expressed in CHO cells by methyl-alpha-D-glucopyranoside assay	2022	Bioorganic & medicinal chemistry letters, 01-15, Volume: 56	Discovery of GCC5694A: A potent and selective sodium glucose co-transporter 2 inhibitor for the treatment of type 2 diabetes.
AID487644	Selectivity ratio of IC50 for human SGLT1 to IC50 for human SGLT2	2010	Bioorganic & medicinal chemistry, Jun-15, Volume: 18, Issue:12	ortho-Substituted C-aryl glucosides as highly potent and selective renal sodium-dependent glucose co-transporter 2 (SGLT2) inhibitors.
AID589977	Inhibition of human SGLT2 expressed in CHO cells assessed as inhibition of [14C]-alpha-methyl-D-glucopyranoside transport after 60 mins by scintillation counting in presence of 100% plasma	2011	Bioorganic & medicinal chemistry letters, Apr-15, Volume: 21, Issue:8	Discovery of non-glucoside SGLT2 inhibitors.
AID1775448	Antidiabetic activity in high fat diet-induced obese Sprague-Dawley rat model assessed as reduction in plasma insulin level at 5 mg/kg, po administered for 10 weeks under HFD condition followed by overnight fasting prior to compound redosing on day 58/59
AID1346950	Human Sodium/glucose cotransporter 1 (Hexose transporter family)	2011	Bioorganic & medicinal chemistry letters, Apr-15, Volume: 21, Issue:8	Discovery of non-glucoside SGLT2 inhibitors.
AID1346965	Human Sodium/glucose cotransporter 2 (Hexose transporter family)	2010	Bioorganic & medicinal chemistry, Aug-15, Volume: 18, Issue:16	Synthesis of pyridazine and thiazole analogs as SGLT2 inhibitors.
AID1798018	SGLT Binding Assay from Article 10.1021/jm701272q: \\Discovery of Dapagliflozin: A Potent, Selective Renal Sodium-Dependent Glucose Cotransporter 2 (SGLT2) Inhibitor for the Treatment of Type 2 Diabetes.\\	2008	Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5	Discovery of dapagliflozin: a potent, selective renal sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor for the treatment of type 2 diabetes.
AID1347411	qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary	2020	ACS chemical biology, 07-17, Volume: 15, Issue:7	High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	17 (1.18)	29.6817
2010's	627 (43.39)	24.3611
2020's	801 (55.43)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	368 (24.90%)	5.53%
Reviews	251 (16.98%)	6.00%
Case Studies	39 (2.64%)	4.05%
Observational	30 (2.03%)	0.25%
Other	790 (53.45%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (437)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys? [NCT05788276]	Phase 4	330 participants (Anticipated)	Interventional	2023-05-02	Recruiting
A Registry-based, Randomised, Double-blind, Placebo-Controlled Cardiovascular Outcomes Trial to Evaluate the Effect of Dapagliflozin on Cardiometabolic Outcomes in Patients Without Diabetes With Acute Myocardial Infarction at Increased Risk for Subsequent [NCT04564742]	Phase 3	4,017 participants (Actual)	Interventional	2020-12-22	Completed
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus [NCT01165268]	Phase 1	24 participants (Actual)	Interventional	2010-08-31	Completed
Inhibition of Urinary Angiotensinogen and the Reduction of Blood Pressure by SGLT2 Inhibition in Patients With Type 2 Diabetes [NCT02796170]	Phase 4	11 participants (Actual)	Interventional	2016-03-31	Completed
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg After Oral Administration in Healthy Male Adults [NCT03766724]	Phase 1	42 participants (Actual)	Interventional	2018-11-22	Completed
A Two Arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of the Combined Use of Once Daily 10mg Dapagliflozin and Once Weekly 1.0mg Semaglutide in Kidney Transplant Recipients [NCT05938712]	Phase 2	20 participants (Anticipated)	Interventional	2023-10-24	Recruiting
SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardio- and Nephroprotection [NCT03919656]	Phase 4	60 participants (Anticipated)	Interventional	2019-05-31	Not yet recruiting
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects [NCT01135446]	Phase 1	35 participants (Actual)	Interventional	2010-05-31	Completed
A Randomized Study of the Effects of Dapagliflozin+Saxagliptin in Addition to Metformin Versus Single Addition Saxagliptin or Dapagliflozin on Glucose Metabolism in Patients With DM2 Poorly Controlled With Metformin [NCT03714594]	Phase 2	48 participants (Actual)	Interventional	2018-07-24	Completed
Dapagliflozin in Non Alcoholic Fatty Liver Disease Associated Cirrhosis and Its Role in Preventing Development of Chronic Kidney Disease. A Randomized Controlled Trial. [NCT05849220]		144 participants (Anticipated)	Interventional	2023-05-15	Not yet recruiting
Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM): a Multicenter Randomized Controlled Trial [NCT05848102]	Phase 4	166 participants (Anticipated)	Interventional	2022-12-23	Recruiting
A Prospective, Multicenter, Phase -IV Study to Assess the Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) Patients [NCT04445714]	Phase 4	200 participants (Actual)	Interventional	2021-04-07	Completed
Administration of the SGLT-2 Inhibitor Dapagliflozin in the Patients With Amyloid Cardiomyopathy: a Pilot Study [NCT05795400]		40 participants (Anticipated)	Interventional	2022-06-01	Recruiting
Observational Retrospective Cohort Study to Evaluate the Benefits, Documented in Experimental Settings, of Treatment With DAPAGLIFLOZIN in Normal Clinical Practice, in Subjects With Type 2 Diabetes [NCT05418946]		1,400 participants (Anticipated)	Observational	2022-06-30	Not yet recruiting
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure With Reduced Ejection Fraction [NCT03036124]	Phase 3	4,744 participants (Actual)	Interventional	2017-02-08	Completed
Evaluating the Effect of Dapagliflozin, an SGLT-2 Inhibitor, on the Counterregulatory Response to Hypoglycemia in Individuals With Type 1 Diabetes [NCT03704818]	Phase 1	22 participants (Actual)	Interventional	2018-10-08	Active, not recruiting
MaasFlex: Double-Blind, Randomized, Phase IV, Mechanistic, Placebo-Controlled, Cross-Over, Single-Center Study to Evaluate the Effects of 2 Weeks Dapagliflozin Treatment on Nocturnal Substrate Oxidation, Glucose Metabolism and Muscle Mitochondrial Functio [NCT03721874]	Phase 4	16 participants (Actual)	Interventional	2019-04-30	Completed
Early Treatment of Heart Failure: a Non-Interventional Observational Study of Italian Patients With Heart Failure and Initiated on Dapagliflozin [NCT05250011]		252 participants (Actual)	Observational	2022-04-19	Active, not recruiting
Preservation of Beta Cell Function in Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT) [NCT02969798]		700 participants (Anticipated)	Interventional	2014-01-01	Recruiting
Dapagliflozin During Exercise for the Prevention of Hypoglycaemia in Type 1 Diabetes [NCT03537131]	Phase 2	9 participants (Actual)	Interventional	2018-06-02	Terminated(stopped due to Temporary halt due to COVID-19 pandemic)
DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction [NCT05764057]	Phase 3	450 participants (Anticipated)	Interventional	2023-06-12	Recruiting
Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell [NCT02420392]		30 participants (Actual)	Interventional	2015-02-28	Completed
A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants With Chronic Kidney Disease and High Proteinuria [NCT06087835]	Phase 3	1,500 participants (Anticipated)	Interventional	2023-11-07	Recruiting
Does Glycated Hemoglobin Variability in Type 2 Diabetes Differ Depending on the Diabetes Treatment Threshold Used in the Qatari Population: Implication on Diabetes Complication Risk? [NCT02879409]		150 participants (Anticipated)	Interventional	2016-11-30	Active, not recruiting
A Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate Microvascular Disease After 12 Weeks of Therapy With Sodium-glucose Co-transporter 2 Inhibitor Compared to Placebo in Symptomatic Women With Non-obstructive Coronary Artery Di [NCT05762952]	Phase 1	40 participants (Anticipated)	Interventional	2023-05-24	Recruiting
A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients [NCT03387683]	Phase 4	53 participants (Actual)	Interventional	2018-02-28	Completed
Therapeutic Efficacy and Safety of Sitagliptin, Dapagliflozin and Lobeglitazone in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Glimepiride and Metformin. [NCT02338921]	Phase 4	78 participants (Actual)	Interventional	2015-01-31	Completed
DAPAMAAST: A Double-blind, Randomized, Phase IV, Mechanistic, Placebo-controlled, Cross-over, Single-center Study to Evaluate the Effects of 5 Weeks Dapagliflozin Treatment on Insulin Sensitivity in Skeletal Muscle in Type 2 Diabetes Mellitus Patients. [NCT03338855]	Phase 4	26 participants (Actual)	Interventional	2018-03-05	Completed
Pharmacokinetics and Dialyzability of Dapagliflozin in Dialysis Patients: on Behalf of the DARE-ESKD Trial [NCT05343078]	Phase 4	5 participants (Actual)	Interventional	2022-04-25	Completed
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease [NCT03036150]	Phase 3	4,304 participants (Actual)	Interventional	2017-02-02	Completed
A Prospective, Open, Multicenter, Clinical Study of Huangqi Guizhi Wuwu Decoction in Treating Diabetic Nephropathy (Stage CKD2-4) [NCT05418465]		100 participants (Anticipated)	Interventional	2022-01-26	Recruiting
Dapagliflozin Effect on Rheumatic Mitral Stenosis [NCT05618223]	Phase 3	36 participants (Anticipated)	Interventional	2022-12-01	Not yet recruiting
Effect of Glucagon Receptor Antagonism on Ketogenesis in SGLT-2i Treated Subjects With T1D [NCT04545411]	Phase 1/Phase 2	12 participants (Actual)	Interventional	2021-02-22	Completed
Metformin And Cardiovascular Effectiveness vs SGLT2 (MACES) [NCT03627039]		20,000 participants (Anticipated)	Observational	2018-09-01	Active, not recruiting
Hepato-renal Regulation of Water Conservation in Heart Failure Patients With SGLT-2 Inhibitor Treatment [NCT04080518]	Phase 4	40 participants (Actual)	Interventional	2019-11-11	Completed
An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Gemigliptin and Dapagliflozin or Empagliflozin in Healthy Adult Volunteers [NCT03565458]	Phase 1	48 participants (Actual)	Interventional	2018-04-05	Active, not recruiting
Efficacy and Safety of Dapagliflozin in Patients With Chronic Kidney Disease Stage 4-5 Under Integrated CKD Care Program: An Investigator-led, Randomized, Open-label, Blinded-endpoint, Multicenter Study [NCT05196347]	Phase 3	225 participants (Anticipated)	Interventional	2022-03-01	Not yet recruiting
Evaluation of the Safety and Efficacy of SGLT2 Inhibitors in Pre-diabetic Patients: A Randomized Trial [NCT05914857]	Phase 2	120 participants (Anticipated)	Interventional	2023-12-20	Not yet recruiting
A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonyl [NCT00660907]	Phase 3	1,217 participants (Actual)	Interventional	2008-03-31	Completed
Effect of Dapagliflozin on Submaximal Exercise Tolerance in Heart Failure [NCT04956809]	Phase 2	3 participants (Actual)	Interventional	2021-10-22	Completed
A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Contr [NCT01257412]	Phase 3	375 participants (Anticipated)	Interventional	2012-01-31	Suspended(stopped due to FSI delayed until 15 January 2013)
Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes [NCT03887416]	Phase 4	225 participants (Anticipated)	Interventional	2019-04-12	Recruiting
An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/1000 mg) in Healthy Male and Female Volunteers [NCT01156246]	Phase 1	18 participants (Actual)	Interventional	2010-06-30	Completed
A Prospective, Randomized, Open Label, Parallel, 16-week Study to Explore and Evaluate the Therapeutic Effects of Liraglutid, Dapagliflozin and Acarbose on the Cognitive Function, Olfactory Function, and Odor-induced Brain Activation in Overweight/Obese P [NCT03961659]		87 participants (Anticipated)	Interventional	2019-05-31	Recruiting
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Study to Evaluate the Efficacy and Safety of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin [NCT05505994]	Phase 3	298 participants (Anticipated)	Interventional	2022-09-30	Not yet recruiting
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of THP-00101 and THP-00102 in Healthy Adult Volunteers [NCT06063109]	Phase 1	51 participants (Actual)	Interventional	2023-10-09	Completed
A Multicenter, Register-based, Randomized, Controlled Trial Comparing Dapagliflozin With Metformin Treatment in Early Stage Type 2 Diabetes Patients by Assessing Mortality and Macro- and Microvascular Complications [NCT03982381]	Phase 4	2,067 participants (Actual)	Interventional	2019-09-05	Active, not recruiting
A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial With a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients [NCT03199053]	Phase 3	256 participants (Actual)	Interventional	2017-10-11	Active, not recruiting
An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2811 in Healthy Subjects [NCT04473417]	Phase 1	60 participants (Actual)	Interventional	2020-08-04	Completed
Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus [NCT03249506]		25,358 participants (Actual)	Observational	2016-05-12	Completed
A Study to Assess the Renoprotective Effects of the SGLT2 Inhibitor Dapagliflozin in Non-Diabetic Patients With Proteinuria: a Randomized Double Blind 6-Weeks Cross-Over Trial [NCT03190694]	Phase 2	50 participants (Anticipated)	Interventional	2017-11-12	Active, not recruiting
Randomized, Placebo Controlled, Crossover Clinical Study to Analyse the Effect of Dapagliflozin on Microvascular and Macrovascular Circulation and Total Body Sodium Content [NCT02383238]	Phase 3	59 participants (Actual)	Interventional	2014-03-31	Completed
Effect of Dapagliflozin on the Progression From Prediabetes to T2DM in Subjects With Myocardial Infarction [NCT03658031]	Phase 3	576 participants (Anticipated)	Interventional	2019-03-01	Not yet recruiting
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of YYC405-T Added to Metformin and Dapagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control [NCT05226897]	Phase 3	256 participants (Anticipated)	Interventional	2021-07-12	Active, not recruiting
A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in C [NCT02419612]	Phase 3	444 participants (Actual)	Interventional	2015-08-14	Completed
Effects of SGLT2 Inhibitor on Markers of Inflammation, Atherosclerosis and Left Ventricular Strain in Diabetic Patients With Coronary Artery Disease [NCT03398577]	Phase 4	61 participants (Anticipated)	Interventional	2018-02-01	Not yet recruiting
Obesity Treatment to Improve Diabetes [NCT05390307]		60 participants (Anticipated)	Interventional	2023-04-01	Recruiting
Effect of Dapagliflozin on Secondary Mitral Regurgitation in Patients With Left Ventricular Dysfunction [NCT05849766]	Phase 3	150 participants (Anticipated)	Interventional	2023-04-27	Recruiting
Comparative Study of Dapagliflozin Versus Glibenclamide Effect on Endothelial Function of Coronary Artery Disease Patients [NCT02919345]	Phase 4	98 participants (Actual)	Interventional	2017-01-31	Completed
A Randomised Trial Examining Therapy to Maintain Remission in Dilated Cardiomyopathy [NCT06091475]		50 participants (Anticipated)	Interventional	2023-10-20	Not yet recruiting
Sodium-glucose Cotransporter 2 Inhibitor, Aldosterone Antagonist, or Both for Heart Failure With Preserved Ejection Fraction: a Two-centre Randomised Three-treatment Three-period Crossover Trial [NCT05676684]	Phase 2/Phase 3	108 participants (Anticipated)	Interventional	2022-09-15	Recruiting
Efficacy and Safety of Dapagliflozin for the Hospital Management of Patients With Type 2 Diabetes: a Prospective, Open-label, Non-inferiority Randomized Trial [NCT05457933]	Phase 4	250 participants (Actual)	Interventional	2022-07-29	Completed
Effect of Dapagliflozin vs Sitagliptin on Liver Fat Accumulation and Body Composition in Patients With Diabetes Mellitus and Liver Transplantation: a Randomized Controlled Trial [NCT05042505]		100 participants (Anticipated)	Interventional	2022-01-01	Recruiting
Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction. A 35-week, Single-center, Prospective, Double-blind, Controlled, Randomized, 2x2 Crossover, Interventional Phase II Study, Investiga [NCT04475042]	Phase 2	26 participants (Anticipated)	Interventional	2020-07-01	Recruiting
Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet Under Fed and Fasting Conditions in Healthy Volunteers [NCT05105698]	Phase 1	28 participants (Anticipated)	Interventional	2022-01-01	Not yet recruiting
Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D) [NCT02973477]	Phase 4	45 participants (Actual)	Interventional	2017-01-12	Completed
Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects (11038) [NCT02981966]	Phase 4	32 participants (Actual)	Interventional	2019-05-23	Active, not recruiting
Randomized, Double-blind, Placebo-controlled, Single-center Phase 1 Study to Explore the Safety and Pharmacokinetics of DAPAglifozin as Add-on to Intravenous Insulin-infusion in Adolescents and Adults With Type 1 Diabetes [NCT02325206]	Phase 1	36 participants (Actual)	Interventional	2014-12-31	Completed
Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT [NCT05014594]	Phase 2	44 participants (Anticipated)	Interventional	2021-09-03	Recruiting
Effect of Short-term Dapagliflozin on Renal Function After Heart Catheterization or Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease [NCT05225077]	Phase 4	600 participants (Anticipated)	Interventional	2022-01-01	Recruiting
Multicenter Prospective Cohort Study of the Hypoglycemic Efficacy, Weight Control, and Safety in Newly-diagnosed Type 2 Diabetes: Triple Combination Therapy Using Metformin, Saxagliptin Plus Dapagliflozin Versus Premixed Insulin [NCT03700801]	Phase 4	130 participants (Anticipated)	Interventional	2018-10-31	Not yet recruiting
A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of Dapagliflozin/Metformin XR Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese [NCT04856007]	Phase 1	80 participants (Actual)	Interventional	2021-04-12	Completed
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Ha [NCT04170998]	Phase 3	283 participants (Actual)	Interventional	2020-01-02	Completed
A Multicenter, Randomized, Double-Blind, Parallel, Active-Controlled Phase III Study on Metformin Combined With THR-1442 or Dapagliflozin in T2DM [NCT05159882]	Phase 3	390 participants (Anticipated)	Interventional	2021-04-15	Recruiting
Effects of SGLT-2 Inhibition With Dapagliflozin on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI With T1- and T2-mapping in Patients With Type-2 Diabetes [NCT03782259]	Phase 4	62 participants (Actual)	Interventional	2019-02-26	Completed
Impact of Dapagliflozin on Intestinal Microbiota Composition and on the Metabolites Derived From the Intestinal Microbiota in Non-diabetic Chronic Renal Failure Patients [NCT05965440]		50 participants (Anticipated)	Interventional	2023-10-02	Recruiting
Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV) [NCT05816733]	Phase 4	348 participants (Anticipated)	Interventional	2023-09-01	Recruiting
Intraclass Safety and Efficacy Comparison Among SGLT-2 Inhibitors in Elderly Patients With Type 2 Diabetes. A Pragmatic, Phase IV, Multicenter, Open-label, Randomised Controlled Trial. [NCT04796428]	Phase 4	1,167 participants (Anticipated)	Interventional	2021-06-30	Not yet recruiting
A 28-week, Multi-center Randomized, Double-blind, Placebo-controlled Study to Evaluate the Potential of Dapagliflozin Plus Exenatide in Combination With High-dose Intensive Insulin Therapy Compared to Placebo in Obese Insulin-resistant Patients With Type [NCT03419624]	Phase 3	13 participants (Actual)	Interventional	2018-02-19	Terminated(stopped due to Delay in patient enrolment)
Comparative Study of Dapagliflozin Versus Glimepiride Effect on Insulin Regulated Aminopeptidase (IRAP) and Interleukin-34 (IL-34) in Patient With Type 2 Diabetes Mellitus [NCT04240171]		60 participants (Actual)	Observational [Patient Registry]	2020-12-01	Completed
Assessment of the Renin-angiotensin-aldosterone System (RAAS) and Antidiuretic Function in Patients With Type 2 Diabetes Before and During Treatment With Sodium-glucose Co-transporter 2 Inhibitors (SGLT2i): the GliRACo 1 Study [NCT03917758]		30 participants (Anticipated)	Interventional	2018-10-10	Recruiting
DOUBLE PRO-TECT Alport: A Confirmatory, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Dapagliflozin on the Progression of Chronic Kidney Disease in Adolescents and Young Adult Patients With Alport Syndrom [NCT05944016]	Phase 3	102 participants (Anticipated)	Interventional	2023-12-31	Not yet recruiting
Reduction of Peritoneal Glucose Uptake With Use of SGLT2 in Humans Undergoing Peritoneal Dialysis Treatment. A Proof of Concept Phase 2a Clinical Trial. [NCT05250752]	Phase 2	10 participants (Anticipated)	Interventional	2021-11-18	Enrolling by invitation
TreatIng Microalbuminuria Over 24 Weeks in Subjects With or Without Type 2 Diabetes or HYpertension [NCT05268926]	Phase 2	9 participants (Actual)	Interventional	2022-02-03	Terminated(stopped due to Due to a delayed start-up and delayed patient inclusion in combination with new available scientific data, continuation of the clinical study no longer serves a scientific purpose.)
Effect of Dapagliflozin at Discharge on Hospital Re-Admissions in Patients With Acutely Decompensated Heart Failure: A Randomized Controlled Study [NCT04249778]	Phase 4	105 participants (Actual)	Interventional	2020-07-29	Completed
The Potential Beneficial Effects of SGLT2 Inhibitors in Patients With Acute Decompensated Heart Failure During Ventilator Weaning: a Prospective Multicenter Cohort Study. [NCT06142474]	Phase 3	450 participants (Anticipated)	Interventional	2022-10-10	Recruiting
Adolescent Type 1 Diabetes Treatment With SGLT2i for hyperglycEMia & hyPerfilTration Trial [NCT04333823]	Phase 3	100 participants (Anticipated)	Interventional	2020-12-11	Active, not recruiting
A 24-week, Single Centre, Randomized, Parallel-group, Double-blind, Placebo Controlled Phase II Study With an Optional 28-week Open-label Extension to Evaluate the Efficacy on Body Weight of Dapagliflozin 10 mg Once Daily in Combination With Exenatide 2 m [NCT02313220]	Phase 2	50 participants (Actual)	Interventional	2014-12-31	Completed
Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Patients With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease [NCT03492580]		714,582 participants (Actual)	Observational	2018-02-22	Completed
The Effect of Early Inpatient Initiation of Dapagliflozin on the Health-related Quality of Life of Patients With Heart Failure With All Range of Ejection Fraction: a Local Registry [NCT05759000]		100 participants (Anticipated)	Observational [Patient Registry]	2023-04-09	Not yet recruiting
A Pilot Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy for Patient With HER2-negative Early-stage Breast Cancer and Hyperinsulinemia [NCT05989347]	Phase 1	20 participants (Anticipated)	Interventional	2023-12-31	Not yet recruiting
Efficacy and Safety of Dapagliflozin in Polycystic Ovary Syndrome: a Multicentre, Randomized, Placebo-controlled Trial [NCT04213677]	Phase 3	165 participants (Actual)	Interventional	2020-03-20	Completed
Quantifying Uric Acid Excretion With RDEA3170, Febuxostat and Dapagliflozin [NCT03316131]	Phase 2	36 participants (Actual)	Interventional	2017-10-25	Completed
A Randomized Controlled Clinical Trial to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe Chronic Kidney Disease [NCT05374291]	Phase 3	1,500 participants (Anticipated)	Interventional	2022-11-08	Enrolling by invitation
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects [NCT00842556]	Phase 1	18 participants (Actual)	Interventional	2009-03-31	Completed
Value of SGLT2 Inhibitor (Dapagliflozin) as an Added Therapy in Diabetic Patients With Heart Failure With Reduced Ejection Fraction; Randomized Controlled Clinical Trial [NCT04304560]	Phase 2	60 participants (Anticipated)	Interventional	2020-03-31	Not yet recruiting
A 24-week, Multicentre, Randomised, Double-blind, Age-stratified, Placebo Controlled, Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Pts With T2DM, CV Disease and Hypertension Who E [NCT01031680]	Phase 3	922 participants (Actual)	Interventional	2010-02-28	Completed
SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes - a Randomized, Placebo Controlled, Multi-center Trial [NCT06054035]	Phase 4	182 participants (Anticipated)	Interventional	2023-10-15	Not yet recruiting
A Long Term Open Label Study to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy or Combination Therapies With Anti-diabetic Drugs in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control [NCT01294436]	Phase 3	728 participants (Actual)	Interventional	2011-02-28	Completed
A Study of the Effects of Dapagliflozin on Ambulatory Aortic Pressure, Arterial Stiffness and Urine Albumin Excretion in Patients With Type 2 Diabetes [NCT02887677]	Phase 4	85 participants (Actual)	Interventional	2016-10-31	Terminated(stopped due to On February 2019 Astra-Zeneca Greece decided to stop the financial support of the study.)
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus [NCT00726505]	Phase 1	1 participants (Actual)	Interventional	2009-06-30	Terminated
The Effect of Sodium Glucose Co-transporter 2 (SGLT2)-Inhibitors on Sleep Disordered Breathing in Heart Failure Patients [NCT04640493]	Phase 2	20 participants (Anticipated)	Interventional	2023-12-31	Not yet recruiting
The Safety of Dapagliflozin in Hemodialysis Patients With Heart Failure [NCT05141552]		20 participants (Anticipated)	Interventional	2022-01-03	Recruiting
A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes W [NCT00673231]	Phase 3	1,240 participants (Actual)	Interventional	2008-04-30	Completed
A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group, Phase 3 Trial to Evaluate the Efficacy and Safety of Dual add-on Therapy With Gemigliptin 50 mg and Dapagliflozin 10 mg Added to Metformin Compared to add-on Therapy [NCT04255238]	Phase 3	468 participants (Anticipated)	Interventional	2020-06-30	Not yet recruiting
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects [NCT00839683]	Phase 1	24 participants (Actual)	Interventional	2009-02-28	Completed
Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List: a Multicenter, Double-blind, Randomized Clinical Trial. [NCT04782245]	Phase 2	0 participants (Actual)	Interventional	2022-09-30	Withdrawn(stopped due to New recommandations)
EPIK-B4: A Phase II, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR During Treatment With Alpelisib (BYL719) in Combination With Fulvestrant in Participant [NCT04899349]	Phase 2	2 participants (Actual)	Interventional	2022-04-06	Terminated(stopped due to Study was early terminated due to slow recruitment and emerging data showing that prophylactic use of metformin may prevent or reduce the incidence of all-grades alpelisib-related hyperglycemia. The decision was not driven by safety concerns)
A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in [NCT02551874]	Phase 3	650 participants (Actual)	Interventional	2015-10-20	Completed
A Randomised, 3-Period, 3-Treatment, Single-dose, Open-label, Single-center, Crossover Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxag [NCT03169959]	Phase 1	85 participants (Actual)	Interventional	2017-05-29	Completed
Efficacy and Safety of Dapagliflozin Compared to Pioglitazone in Diabetic and Non-diabetic Patients With Non-alcoholic Steatohepatitis [NCT05254626]	Phase 4	100 participants (Anticipated)	Interventional	2022-08-01	Recruiting
A Randomized, Single-dose, Open-label, Single-center, Crossover Study to Assess the Fed- and Fasted State Bioequivalence of Fixed-Dose Combination Tablets of Saxagliptin / Dapagliflozin / Metformin XR and Dapagliflozin / Metformin XR Relative to Individua [NCT03138356]	Phase 1	126 participants (Actual)	Interventional	2017-05-25	Completed
Effect of the Administration of the Combination of Dapagliflozin Plus Metformin XR Versus Monotherapies on Anthropometric Indicators in Patients With Grade 1 Obesity. [NCT03710460]	Phase 4	33 participants (Anticipated)	Interventional	2019-07-30	Recruiting
A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformi [NCT02471404]	Phase 4	939 participants (Actual)	Interventional	2015-09-21	Completed
Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) Inhibition [NCT04542291]	Phase 1	15 participants (Actual)	Interventional	2021-02-25	Completed
The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes [NCT06127433]	Phase 4	210 participants (Anticipated)	Interventional	2023-03-07	Recruiting
Bioequivalence Study of Dapagliflozin 10 mg Film-coated Tablet Produced by PT Dexa Medica in Comparison With the Comparator Drug (Forxiga® 10 mg Film-Coated Tablet, Manufactured by AstraZeneca Pharmaceuticals LP, USA for AstraZeneca Pharmaceuticals Co. Lt [NCT06127212]		24 participants (Actual)	Interventional	2023-03-08	Completed
Dapagliflozin Cardiovascular Effects on Patients at End-stage Renal Disease [NCT05685394]	Phase 4	80 participants (Anticipated)	Interventional	2023-01-24	Recruiting
Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients - DACAMI (a Randomized Controlled Clinical Trial) [NCT05424315]	Phase 2/Phase 3	100 participants (Actual)	Interventional	2021-10-01	Completed
Effect of the SGLT-2 Inhibitor Dapagliflozin on Impaired Awareness of Hypoglycemia in Type 1 Diabetes [NCT03556033]	Phase 2	15 participants (Actual)	Interventional	2018-11-23	Completed
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects [NCT05066516]	Phase 1	48 participants (Actual)	Interventional	2020-06-25	Completed
Randomized, Double-blind, Placebo-controlled Trial on the Effectiveness and Safety of Dapagliflozin for Blood Glucose Control During Glucocorticoid Treatment for Acute Exacerbation COPD [NCT02253121]	Phase 4	46 participants (Actual)	Interventional	2015-02-28	Completed
Alfapump® DSR Feasibility Study in Subjects With Persistent Congestion Due to Heart Failure, Resistant to Loop Diuretic Treatment [NCT04882358]		24 participants (Anticipated)	Interventional	2021-05-27	Active, not recruiting
A Bioequivalence Study of 2.5-mg Saxagliptin/5-mg Dapagliflozin and 5-mg Saxagliptin/10-mg Dapagliflozin Fixed Dose Combination Tablets Relative to Coadministration of Their Respective Individual Components in Healthy Subjects and a Characterization of th [NCT02060201]	Phase 1	72 participants (Actual)	Interventional	2014-02-28	Completed
A Multicenter, Randomized, Active-controlled, Parallel Group, Open-label, Phase 4 Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin 50mg q.d., Versus Dapagliflozin 10mg q.d. Added to Subjects With Type 2 Diabetes Who Have In [NCT03202563]	Phase 4	71 participants (Actual)	Interventional	2017-08-09	Completed
Effects of DAPAgliflozin on Cardiopulmonary Exercise Capacity and Hemodynamics in Pulmonary Arterial Hypertension: A Double Blind Randomized Trial. (DAPAH-trial) [NCT05179356]	Phase 2	52 participants (Anticipated)	Interventional	2023-01-01	Recruiting
Dapagliflozin After Transcatheter Aortic Valve Implantation [NCT04696185]	Phase 4	1,020 participants (Anticipated)	Interventional	2021-01-27	Recruiting
Polypill Versus Metformin in New Onset Type 2 Diabetes: a Low Dose Triple Therapy Polypill Versus Metformin for Glycaemic Control in Newly Diagnosed Type 2 Diabetes [NCT05833958]	Phase 2	334 participants (Anticipated)	Interventional	2024-01-31	Not yet recruiting
Dapagliflozin in Patients With Critical Illness: A Randomized Controlled Trial [NCT05558098]	Phase 3	507 participants (Actual)	Interventional	2022-11-01	Completed
Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction [NCT06009874]		80 participants (Anticipated)	Interventional	2023-10-31	Recruiting
SGLT2 Inhibitors As First Line Therapy to Prevent Renal Decline in Type 2 Diabetes [NCT05345327]	Phase 3	994 participants (Anticipated)	Interventional	2023-01-01	Recruiting
Effect of Adjuvant Dapagliflozin on Improving the Treatment of Congestion in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF) [NCT05406505]	Phase 2/Phase 3	87 participants (Actual)	Interventional	2022-04-25	Completed
Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome [NCT06026787]	Phase 4	60 participants (Actual)	Interventional	2022-08-01	Completed
Sodium-glucose Transport 2 Inhibitors (SGLT2i) in Heart Failure Reduced Ejection Fraction (HFrEF) Patients [NCT06065280]		80 participants (Anticipated)	Interventional	2022-09-01	Recruiting
Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease [NCT05719714]	Phase 1/Phase 2	60 participants (Anticipated)	Interventional	2023-11-01	Recruiting
Dapagliflozin Effects on Mayor Adverse Cardiovascular Events in Patients With Acute Myocardial Infarction (DAPA-AMI). Randomized Clinical Trial [NCT04717986]		188 participants (Actual)	Interventional	2021-01-26	Completed
Efficacy of Dapagliflozin in Diabetes Associated Peripheral Neuropathy: A Randomized Placebo Controlled Trial [NCT05162690]	Phase 2/Phase 3	40 participants (Anticipated)	Interventional	2022-05-01	Recruiting
Study of the Effect of Dapagliflozin on the Pharmacokinetics of Warfarin or Digoxin in Healthy Subjects [NCT00904176]	Phase 1	30 participants (Actual)	Interventional	2009-06-30	Completed
A Randomized, Double-Blinded, Placebo-controlled, Single-center Phase 1 Pilot Study to Explore the Effect of DAPAglifozin and Stress ( i.v. ACTH) on the Development of DKA After Insulin Withdrawal in Adolescent and Adult Subjects With T1D [NCT04234867]	Phase 1	2 participants (Actual)	Interventional	2022-05-18	Terminated(stopped due to slow recruitment)
Cardio-Protective of Effect of Saxagliptin and Dapagliflozin Combination on Endothelial Progenitor Cells in Patients With Type 2 Diabetes [NCT03660683]	Phase 4	15 participants (Actual)	Interventional	2018-10-22	Terminated(stopped due to Sponsor did not want to continue funding the study)
Mechanistic Study of the Systolic Blood Pressure Lowering Effect of Dapagliflozin in Type 2 Diabetes [NCT02372955]	Phase 4	21 participants (Anticipated)	Interventional	2015-02-28	Recruiting
Exploring the Association Between Phthalates Exposure, Measured Through Their Urinary Metabolites, and Renal Function Impairment in Individuals With TYpe 2 Diabetes - SGLT2 Subprotocol [NCT04242758]	Phase 4	30 participants (Actual)	Interventional	2019-06-04	Active, not recruiting
A Randomized, Open-Label, Parallel-group, Multiple-Dose Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects [NCT00930865]	Phase 1	42 participants (Actual)	Interventional	2009-07-31	Completed
A Single-dose Cross-over Study to Assess Direct and Indirect Effects of Dapagliflozin on Pancreatic Alpha and Beta Cells in Patients With Type 2 Diabetes [NCT02765204]	Phase 4	15 participants (Actual)	Interventional	2016-03-31	Completed
The Effect of a SGLT2 Inhibitor on Glucose Flux, Lipolysis and Exercise in Type 2 Diabetes [NCT04219124]	Phase 4	9 participants (Actual)	Interventional	2018-09-20	Completed
Impact of Dapagliflozin on DIAstolic Dysfunction in Type 2 Diabetic Patients: The IDDIA Study [NCT02751398]	Phase 4	60 participants (Actual)	Interventional	2016-08-18	Completed
Clinical Efficacy of SGLT-2 Inhibitor After Stent Implantation in Patients With Coronary Heart Disease and Diabetes Mellitus：a Prospective Cohort Study [NCT05333159]		1,424 participants (Anticipated)	Observational	2021-09-01	Recruiting
Dapagliflozin and Hydrochlorothiazide Treatment in Recurring Kidney Stone Patients - a Randomised Single Center Cross-over Study [NCT05443932]	Phase 4	32 participants (Anticipated)	Interventional	2024-03-04	Not yet recruiting
A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects With Type 2 Diabetes Treated Aggressively But Not Controlled on Combination Antihyperglycemic Therapy With Metformin and/or Thiazolidinedione (TZD) and Insulin. [NCT00357370]	Phase 2/Phase 3	163 participants (Actual)	Interventional	2006-10-31	Completed
International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients With Preserved Ejection Fraction [NCT03877224]	Phase 3	504 participants (Actual)	Interventional	2019-04-04	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise [NCT00528372]	Phase 3	1,067 participants (Actual)	Interventional	2007-09-30	Completed
Effect of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in Infertile Women With Polycystic Ovary Syndrome [NCT05601336]	Phase 3	200 participants (Anticipated)	Interventional	2022-01-15	Recruiting
A Phase 2b, Randomised, Double-Blind, Active Controlled, Multi Centre Study to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 and Dapagliflozin Treatment in Patients With Heart Failure and Chronic Kidney Disease [NCT04595370]	Phase 2	153 participants (Actual)	Interventional	2021-01-26	Completed
Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes [NCT05139914]	Phase 4	50 participants (Anticipated)	Interventional	2022-05-31	Recruiting
A Two Part Phase IIa/b Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose-ranging Study to Assess Efficacy, Safety, and Tolerability of the Combination of Zibotentan and Dapagliflozin, and Dapagliflozin Monotherapy Versus Place [NCT05516498]	Phase 2	195 participants (Anticipated)	Interventional	2022-10-31	Recruiting
A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Voluntee [NCT01055691]	Phase 1	120 participants (Actual)	Interventional	2010-01-31	Completed
Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology [NCT04451837]	Phase 2	200 participants (Anticipated)	Interventional	2020-09-10	Active, not recruiting
Evaluation and Intervention of Cognitive Function in Patients With Diabetes Mellitus. [NCT05262257]	Early Phase 1	120 participants (Anticipated)	Interventional	2022-04-01	Not yet recruiting
A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients (DECIDE Study) [NCT02616666]	Phase 4	632 participants (Actual)	Interventional	2016-08-25	Active, not recruiting
Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure . [NCT04707352]	Phase 3	162 participants (Actual)	Interventional	2021-02-08	Completed
A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients With Chronic Kidney Disease [NCT05359263]	Phase 2	222 participants (Anticipated)	Interventional	2022-06-08	Recruiting
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin 10 mg Monotherapy and Metf [NCT00859898]	Phase 3	1,093 participants (Actual)	Interventional	2009-04-30	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes [NCT00831779]	Phase 2	116 participants (Actual)	Interventional	2009-04-30	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Con [NCT00683878]	Phase 3	972 participants (Actual)	Interventional	2008-07-31	Completed
Short and Intermediate Term Effect of Dapagliflozin on Left Ventricular Remodeling in Anterior STEMI Patients [NCT05957887]	Phase 3	120 participants (Anticipated)	Interventional	2022-04-15	Recruiting
SGLT2 INHIBITION AND STIMULATION OF ENDOGENOUS GLUCOSE PRODUCTION [EGP]: Can the Glucagon-like Peptide-1 [GLP-1] Receptor Agonist, Exenatide, Prevent the Increase in EGP in Response to Dapagliflozin-induced Increase in Glucosuria [NCT03331289]	Phase 4	107 participants (Actual)	Interventional	2018-02-28	Completed
A Double-blind, Randomized, Four-period Crossover Study to Assess the Effects of Single Oral Dose Dapagliflozin Administration on QTc Interval Compared to Placebo, Using AVELOX™ (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Age 18 to 45 [NCT00688493]	Phase 1	36 participants (Actual)	Interventional	2007-07-31	Completed
Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS Study) [NCT02577159]	Phase 4	50 participants (Anticipated)	Interventional	2015-07-01	Active, not recruiting
A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. G [NCT00680745]	Phase 3	597 participants (Actual)	Interventional	2008-04-30	Completed
"Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects: The TRANSLATE Study" [NCT02585804]	Phase 4	10 participants (Actual)	Interventional	2015-09-30	Completed
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney Disease [NCT04170543]	Phase 2	609 participants (Actual)	Interventional	2019-11-18	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme [NCT01137474]	Phase 3	2,996 participants (Actual)	Interventional	2010-07-31	Completed
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin Monotherapy and Metformin Monoth [NCT00643851]	Phase 3	994 participants (Actual)	Interventional	2008-06-30	Completed
Efficacy of Exenatide-LAR Alone and in Combination With Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Uncontrolled Type 2 Diabetes [NCT02811484]	Phase 4	0 participants (Actual)	Interventional	2016-06-30	Withdrawn(stopped due to Inability to enroll due to the widespread use of both classes of drugs in patients with T2DM, including those on concomitant insulin therapy.)
The Effects of SGLT Inhibition on Diabetic Cardiomyopathy [NCT04200586]	Phase 4	30 participants (Anticipated)	Interventional	2020-04-09	Active, not recruiting
Effect of Dapagliflozin, Metformin and Physical Activity on Glucose Variability, Body Composition and Cardiovascular Risk in Pre-diabetes [NCT02695810]	Phase 2	120 participants (Actual)	Interventional	2016-02-24	Completed
Comparative Effectiveness of Dapagliflozin Versus DPP-4 Inhibitors on a Composite Endpoint of HbA1c, Body Weight, and Blood Pressure Reduction: A Nationwide Real World Italian Multicentric Study [NCT04304430]		11,206 participants (Actual)	Observational	2018-10-18	Completed
Randomized, Open Prospective Study of the Effect of SGLT-2 Inhibitor Dapagliflozin on Glycemic Variability in Patients With Diabetes Mellitus Type 2 [NCT02719756]	Phase 4	100 participants (Anticipated)	Interventional	2016-04-30	Not yet recruiting
DAPAgliflozin Sodium Water glucosE EffecTs in Patients at High Cardiovascular Risk [NCT04258371]	Phase 2	50 participants (Anticipated)	Interventional	2020-02-10	Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exerci [NCT01095653]	Phase 3	1,179 participants (Actual)	Interventional	2010-06-30	Completed
Effects of SGLT-2 Inhibitor Dapagliflozin on Hormonal Glucose Regulation and Ketogenesis in Patients With Type 1 Diabetes - a Randomised, Placebo-controlled, Open-label, Cross-over Intervention Study [NCT04035031]	Phase 3	13 participants (Actual)	Interventional	2020-01-09	Completed
Effect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in Type 2 Diabetes Mellitus (T2DM) [NCT02981069]	Phase 4	90 participants (Actual)	Interventional	2017-12-15	Completed
Effects of SGLT2 Inhibitors on Islet Cell Function and Insulin Sensitivity in Patients of Type 2 Diabetes Mellitus [NCT04014192]	Phase 4	40 participants (Anticipated)	Interventional	2019-09-01	Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformi [NCT00528879]	Phase 3	915 participants (Actual)	Interventional	2007-09-30	Completed
Safety and Efficacy of Adding Dapagliflozin and Furosemide in Diabetic Patients (Type 2) With Decompensated Heart Failure With Reduced Ejection Fraction (HFrEF) [NCT04385589]	Phase 4	100 participants (Actual)	Interventional	2020-05-01	Completed
Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects [NCT00908271]	Phase 1	7 participants (Actual)	Interventional	2009-07-31	Completed
Evaluation of the Tubular Effects of Dapagliflozin Using 1HNMR Spectroscopy [NCT02798757]	Phase 4	50 participants (Actual)	Interventional	2016-06-30	Completed
A Randomized, Double - Blind, Placebo - Controlled Trial to Investigate the Effect of Dapagliflozin on Ischemia Reperfusion Induced Endothelial Dysfunction of the Forearm Vasculature in Healthy Male Subjects [NCT05217654]	Phase 1	32 participants (Anticipated)	Interventional	2022-02-18	Recruiting
A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy [NCT03762850]	Phase 3	380 participants (Anticipated)	Interventional	2018-12-11	Active, not recruiting
Effect of Dapagliflozin on the Recurrence of Atrial Tachyarrhythmia in Patients Undergoing Catheter Ablation of Atrial Fibrillation - A Randomized Open-Label Phase III Trial [NCT06111443]	Phase 2/Phase 3	196 participants (Anticipated)	Interventional	2023-12-01	Active, not recruiting
Acute Effects of Sodium GlucOse Co-Transporter 2 (SGLT2) Inhibition on Hepatic Glucose and Energy Metabolism [NCT02558270]	Phase 2	20 participants (Anticipated)	Interventional	2016-06-30	Recruiting
Effect of Dapagliflozin, a Sodium Glucose Co-transporter 2 Inhibitor, on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide [NCT02610088]	Phase 4	32 participants (Actual)	Interventional	2015-11-30	Completed
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise [NCT00736879]	Phase 3	497 participants (Actual)	Interventional	2008-09-22	Completed
Effects of Single Doses of Liraglutide and Dapagliflozin on Hyperglycemia and Ketogenesis in Type 1 Diabetes [NCT02777073]	Phase 3	2 participants (Actual)	Interventional	2016-03-31	Completed
Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes [NCT05194592]	Phase 4	122 participants (Anticipated)	Interventional	2022-01-07	Recruiting
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Re [NCT00663260]	Phase 2/Phase 3	631 participants (Actual)	Interventional	2008-06-30	Completed
Effect of Anti-diabetic Drugs on Glycemic Variability. A Comparison Between Gliclazide MR (Modified Release) and Dapagliflozin on Glycemic Variability Measured by Continuous Glucose Monitoring (CGM) in Patients With Uncontrolled Type 2 Diabetes [NCT02925559]	Phase 4	135 participants (Actual)	Interventional	2016-10-31	Completed
A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects [NCT00538174]	Phase 1	36 participants (Actual)	Interventional	2007-11-30	Completed
An Open-label, Multi-centre, Drug-drug Interaction Study to Assess the Effect of Voglibose (0.2 mg Tid) on the Pharmacokinetics, Safety and Tolerability of Single Oral Administration of Dapagliflozin (10 mg) in Japanese Patients With Type 2 Diabetes [NCT01055652]	Phase 1	28 participants (Actual)	Interventional	2010-01-31	Completed
Effectiveness of the Treatment With Dapagliflozin and Metformin Compared to Metformin Monotherapy for Weight Loss on Diabetic and Prediabetic Patients With Obesity Class III [NCT03968224]	Phase 2/Phase 3	90 participants (Anticipated)	Interventional	2018-07-07	Recruiting
Effect of Rifampin on the Pharmacokinetics of Dapagliflozin in Healthy Subjects [NCT01068756]	Phase 1	14 participants (Actual)	Interventional	2010-03-31	Terminated
Effects of Continuous Subcutaneous Insulin Infusion and Oral Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients [NCT03982238]	Phase 4	74 participants (Actual)	Interventional	2019-06-15	Completed
An Open-label, Randomised, Two-period Crossover Study to Assess the Effect of Dapagliflozin on Percent Inhibition of Glucose Re-absorption When Administered Once a Day (10 mg OD) Versus Twice a Day (5 mg BID) in Healthy Male and Female Volunteers [NCT01072578]	Phase 1	16 participants (Actual)	Interventional	2010-02-28	Completed
Effectiveness of Once-weekly Exenatide (BCise) Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept. [NCT03970044]	Phase 4	67 participants (Actual)	Interventional	2019-07-02	Completed
A Double-Blind, Randomized, 2-Way Crossover Study to Compare the Pharmacodynamics of Canagliflozin 300 mg Versus Dapagliflozin 10 mg in Healthy Subjects [NCT01877889]	Phase 1	60 participants (Actual)	Interventional	2013-07-31	Completed
forREAL: FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) PRESCRIPTION EVENT MONITORING PROGRAM [NCT01944618]		5,000 participants (Anticipated)	Observational	2013-10-31	Terminated(stopped due to "Participant Data obtained to 30Sep2015:~Baseline data: 447 6 month data: 253 Program terminated: recruitment target not met. No analysis will be provided.")
Evaluation of the Effect of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors on Diabetic Retinopathy in Patients With Type 2 Diabetes Mellitus [NCT05310916]	Phase 3	60 participants (Anticipated)	Interventional	2022-06-06	Recruiting
An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Dapagliflozin in Respiratory Failure in Patients With COVID-19 [NCT04350593]	Phase 3	1,250 participants (Actual)	Interventional	2020-04-22	Completed
An Observational Cross-sectional Study and a Double-blind Placebo Controlled Randomised Controlled Trial to Assess the Effect of Dapagliflozin on Myocardial Calcium-handling in Patients With Heart Failure- The DAPA-MEMRI Trial. [NCT04591639]		160 participants (Anticipated)	Interventional	2020-08-19	Recruiting
Assessment of the Renoprotective Effect of Dapagliflozin in Non-Diabetic Patients With Nephrotic Syndrome. [NCT05966818]	Phase 4	90 participants (Anticipated)	Interventional	2023-08-01	Not yet recruiting
An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic and Blood Pressure (BP) Control [NCT00976495]	Phase 2	154 participants (Actual)	Interventional	2009-10-31	Completed
Effects of Dapagliflozin, an SGLT2 Inhibitor, on Hemodynamic Parameters, Target Organ Damage and Obesity Profile in Resistant Hypertensive Subjects [NCT03089333]	Phase 4	16 participants (Actual)	Interventional	2016-07-31	Completed
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects [NCT00562250]	Phase 1	11 participants (Actual)	Interventional	2008-05-31	Completed
DAPASALT: An Open Label, Phase IV, Mechanistic, Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Impaired Renal Function [NCT04620590]	Phase 4	17 participants (Anticipated)	Interventional	2021-04-20	Recruiting
Effects of Dapagliflozin on Hypotensive Patients With Depressed Left Ventricular Ejection Fraction After Sacubitril/Valsartan Therapy [NCT04575675]	Phase 4	78 participants (Actual)	Interventional	2020-05-29	Completed
Dapagliflozin And Pulmonary Artery Hemodynamics in Heart Failure With Reduced Ejection Fraction Patients With CardioMEMS® [NCT04570865]	Phase 4	100 participants (Anticipated)	Interventional	2020-12-01	Not yet recruiting
Clinical Trial to Compare the Pharmacokinetics, Safety and Tolerability of the FDC of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg [NCT04544319]	Phase 1	44 participants (Anticipated)	Interventional	2020-10-31	Not yet recruiting
Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease : a Prospective, Randomized, Placebo-controlled Trial [NCT04531397]	Phase 4	0 participants (Actual)	Interventional	2021-01-01	Withdrawn(stopped due to lack of funding)
A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial With a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients Aged 10-24 Years [NCT02725593]	Phase 3	72 participants (Actual)	Interventional	2016-06-22	Completed
Long Term Clinical Efficacy of Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitor in Cystinurics [NCT05058859]	Phase 2	10 participants (Anticipated)	Interventional	2024-08-01	Not yet recruiting
The Effect of Dapagliflozin on the Short-term Prognosis of Patients With Acute Myocardial Infarction [NCT05050500]	Phase 4	300 participants (Anticipated)	Interventional	2023-05-08	Recruiting
Evaluation of the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction (CAMEO-DAPA): A Phase II, Prospective, Double-Blind Study [NCT04730947]	Phase 2	38 participants (Actual)	Interventional	2021-02-24	Completed
The Effect of SGLT-2 Inhibitors on Epicardial Adipose Tissue and Cardiac Function in T2DM Patients With CAD (EpiCAD) [NCT06128096]		360 participants (Anticipated)	Observational	2022-06-01	Recruiting
Preoperative Sodium Glucose Cotransporter 2 Inhibitors for Prevention of Postoperative Acute Kidney Injury in Cardiac Surgery Patients - a Randomized, Placebo-controlled, Multi-centre, Phase IV Clinical Trial [NCT05590143]	Phase 4	784 participants (Anticipated)	Interventional	2023-06-09	Recruiting
International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the Effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients With Reduced Ejection Fraction [NCT03877237]	Phase 3	313 participants (Actual)	Interventional	2019-04-09	Completed
Cardiometabolic Effects of Dapagliflozin in Heart Failure With Reduced or Mildly Reduced Ejection Fraction: an Exploratory Study [NCT05420285]	Phase 2	40 participants (Anticipated)	Interventional	2022-06-26	Recruiting
Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents [NCT04287387]	Phase 4	180 participants (Anticipated)	Interventional	2020-03-02	Not yet recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Me [NCT01095666]	Phase 3	1,484 participants (Actual)	Interventional	2010-06-30	Completed
Acute Effects of Sodium-glucose Cotransporter-2 Inhibition on Renal Oxygenation and Autonomic Function in Type 1 Diabetes [NCT04193566]	Phase 4	30 participants (Actual)	Interventional	2020-02-01	Completed
A Multicentre Randomised Open-Label Crossover 2-Period 2 Treatment Clinical Trial to Evaluate Effect of Dapagliflozin 10 mg Once Daily on the Quality of Life in Patients With Type 2 Diabetes [NCT02719132]	Phase 4	0 participants (Actual)	Interventional	2016-07-31	Withdrawn
The Echocardiographic Left Ventricular Functional Changes of Uncontrolled Diabetes by the Intervention of Dapagliflozin Treatment Trial (ELUCIDATE) [NCT03871621]	Phase 4	76 participants (Actual)	Interventional	2019-04-01	Completed
Impact of Sodium-glucose Cotransporter Type 2 Inhibitors on the Course of Cardiorenal Syndrome in Acute Decompensation of Chronic Heart Failure [NCT04778787]	Phase 4	370 participants (Actual)	Interventional	2021-01-01	Completed
A 24 Week Monocentric Prospective Randomized, Placebo-controlled Trial to Evaluate Efficacy of Combination of Exenatide and Dapagliflozin Compared to Dapagliflozin and Placebo and Its Effects on Hepatic, Myocardial and Pancreatic Fat Distribution in Patie [NCT03007329]	Phase 4	34 participants (Actual)	Interventional	2017-03-08	Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control [NCT00972244]	Phase 2	417 participants (Actual)	Interventional	2009-08-31	Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme [NCT01195662]	Phase 3	2,245 participants (Actual)	Interventional	2010-10-31	Completed
A Double-blind, Placebo-controlled, Randomized, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Bms-512148 in Diabetic Subjects [NCT00162305]	Phase 2	47 participants (Actual)	Interventional	2005-04-30	Completed
A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults With COVID-19 [NCT04505774]	Phase 4	880 participants (Actual)	Interventional	2020-09-04	Active, not recruiting
Efficacy and Safety of Dapagliflozin in Non-diabetic Children With Proteinuria [NCT04534270]	Phase 4	23 participants (Actual)	Interventional	2020-07-06	Completed
Bioavailability Study of Two Prototype Fixed Dose Combination (FDC) Formulations of 10 mg Dapagliflozin and 1000 mg Metformin Extended Release (XR) Tablet Relative to Dapagliflozin 10 mg Tablet and Glucophage® XR 2 X 500 mg Tablets Coadministered to Healt [NCT01002807]	Phase 1	15 participants (Actual)	Interventional	2009-11-30	Completed
A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have I [NCT00855166]	Phase 3	182 participants (Actual)	Interventional	2009-02-28	Completed
Effects of Sodium-glucose Co-transporter-2 Inhibitors on the Cognitive Function in Type 2 Diabetic Patient [NCT04304261]	Phase 3	100 participants (Anticipated)	Interventional	2020-04-01	Recruiting
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone [NCT04634500]	Phase 3	200 participants (Actual)	Interventional	2020-11-18	Completed
The Impact Of Sodium-Glucose Cotransporter 2 Inhibitors on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus [NCT06117137]	Phase 3	150 participants (Anticipated)	Interventional	2023-11-15	Not yet recruiting
Randomized Controlled Pilot Trial Of Dapagliflozin In Alzheimer's Disease [NCT03801642]	Phase 1/Phase 2	48 participants (Actual)	Interventional	2019-01-29	Completed
Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease [NCT05986136]	Phase 2/Phase 3	50 participants (Anticipated)	Interventional	2023-08-20	Recruiting
A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Di [NCT01294423]	Phase 3	261 participants (Actual)	Interventional	2011-02-28	Completed
The Pharmacodynamics, Pharmacokinetics, and Safety of Dapagliflozin in Type 2 Diabetic Subjects With Mild, Moderate, and Severe Renal Impairment [NCT00554450]	Phase 1	40 participants (Actual)	Interventional	2006-03-31	Completed
A 24-week, Multicentre, Randomised, Double-blind,Age-stratified, Placebo Controlled Phase III Study With an 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin 10 mg Once Daily in Patients With T2DM and Cardiovascular Disease, Wh [NCT01042977]	Phase 3	964 participants (Actual)	Interventional	2010-03-31	Completed
Comparison of Dapagliflozin (DAPA) and Once-weekly Exenatide (EQW), Co-administered or Alone, DAPA/ Glucophage (DAPA/MET ER) and Phentermine/Topiramate (PHEN/TPM) ER on Metabolic Profiles and Body Composition in Obese PCOS Women [NCT02635386]	Phase 3	119 participants (Actual)	Interventional	2016-03-22	Completed
Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients [NCT06140537]	Phase 4	80 participants (Anticipated)	Interventional	2023-12-01	Not yet recruiting
Effectiveness and Tolerability of Novel, Initial Triple Combination Therapy With Xigduo (Dapagliflozin Plus Metformin) and Saxagliptin vs. Conventional Stepwise add-on Therapy in Drug-naïve Patients With Type 2 Diabetes [NCT02946632]	Phase 3	104 participants (Anticipated)	Interventional	2016-12-31	Not yet recruiting
A Randomized, Unicenter, Parallel Study of the Effect of Dapagliflozin on Central Blood Pressure Reduction Compared to Glimepiride in Adult Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control. [NCT02919059]	Phase 4	159 participants (Anticipated)	Interventional	2016-12-13	Recruiting
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects [NCT00546741]	Phase 1	18 participants (Actual)	Interventional	2007-11-30	Completed
A Phase 2b Multicentre, Randomised, Double-Blind, Active-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety and Tolerability of Zibotentan and Dapagliflozin in Patients With Chronic Kidney Disease With Estimated Glomerular Filtra [NCT04724837]	Phase 2	542 participants (Actual)	Interventional	2021-04-28	Completed
DAPA-LVH - Does Dapagliflozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes? [NCT02956811]	Phase 4	66 participants (Actual)	Interventional	2017-02-14	Completed
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate G [NCT01392677]	Phase 3	311 participants (Actual)	Interventional	2011-10-31	Completed
The Effect of Early Administration of Dapagliflozin in ST Elevation Myocardial Infarction Patients Presenting With Left Ventricular Systolic Dysfunction [NCT05045274]		300 participants (Anticipated)	Interventional	2021-12-31	Not yet recruiting
Effect of Dapagliflozin on the Blood Pressure Variability and the Ambulatory Arterial Stiffness Index in Individuals With Stage I Hypertension Without Diabetes Mellitus [NCT03592667]	Phase 4	20 participants (Anticipated)	Interventional	2019-02-14	Recruiting
SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative Atrial Fibrillation and Kidney Injury (STENOTYPE Trial) [NCT05852704]	Phase 4	800 participants (Anticipated)	Interventional	2023-10-02	Not yet recruiting
Dapagliflozin in Type 2 Diabetes Patients in Routine Internal Medicine and Endocrinology Outpatient Clinical Care; a Retrospective Cohort Study From Turkey [NCT03407196]		1,683 participants (Actual)	Observational	2017-05-24	Completed
An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes [NCT02962492]	Phase 4	80 participants (Anticipated)	Interventional	2016-11-30	Not yet recruiting
Effects Of Sodium Glucose Cotranspoter 2 Inhibitors On Heart And Kidneys In Fabry Disease Patients; A Prospective, Randomized, Double-Blind, Placebo- Controlled Study. [NCT05710367]	Phase 2	46 participants (Anticipated)	Interventional	2023-08-31	Not yet recruiting
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III Study to Evaluate the Glycemic Efficacy and Renal Safety of Dapagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) Who Have Inad [NCT02413398]	Phase 3	321 participants (Actual)	Interventional	2015-06-15	Completed
Dapagliflozin Effects on Coronary Calcium and Epicardial Fat Assessed by Cardiotomography [NCT05998525]	Phase 3	54 participants (Actual)	Interventional	2021-06-21	Completed
Pilot Clinical Trial of Neoadjuvant SGLT2 Inhibition in High-Risk Localized Prostate Cancer [NCT04887935]	Phase 1	24 participants (Anticipated)	Interventional	2023-12-31	Not yet recruiting
A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of SID1903 (Fixed-dose Combination of Dapagliflozin and Sitagliptin) or Loose Combination in Healthy Adult Volunteers [NCT05236998]	Phase 1	45 participants (Actual)	Interventional	2021-11-03	Completed
Clinical Outcomes of Dapagliflozin in Acute Heart Failure, a Randomized Controlled Trial [NCT06012279]	Phase 4	110 participants (Anticipated)	Interventional	2023-08-01	Recruiting
A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants With Proteinuric Chronic Kidney Disease [NCT04492722]	Phase 2	613 participants (Actual)	Interventional	2020-10-01	Terminated(stopped due to The Sponsor decided to terminate the study early due to lack of efficacy. There were no safety concerns related to the study.)
Effect of Dapagliflozin for Remission of Type 2 Diabetes Mellitus: A Multicenter, Randomized, Placebo-Controlled Trial [NCT04004793]	Phase 4	328 participants (Actual)	Interventional	2020-08-15	Active, not recruiting
SGLT2 Inhibition (Dapagliflozin) in Diabetic and Non-diabetic Hemodialysis Patients With and Without Residual Urine Volume: a Prospective Randomized, Placebo-controlled, Double-blinded Phase II Trial [NCT05179668]	Phase 2	108 participants (Anticipated)	Interventional	2022-10-01	Recruiting
Assessment of Safety and Efficacy of Sodium Glucose Co-transporter 2 Inhibitors Among Lupus Nephritis Patients [NCT06113900]	Phase 1/Phase 2	50 participants (Anticipated)	Interventional	2023-12-01	Not yet recruiting
An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF) [NCT03619213]	Phase 3	6,263 participants (Actual)	Interventional	2018-08-27	Completed
Head-to-head Comparison of Quadruple Combination Therapy With Empagliflozin and Dapagliflozin in Patients With Poorly Controlled Type 2 Diabetes (T2D) Despite Three Existing Oral Antidiabetic Drugs (OAD) [NCT03748810]		600 participants (Actual)	Observational [Patient Registry]	2016-01-01	Completed
Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Remodeling [NCT05606718]	Phase 4	98 participants (Anticipated)	Interventional	2022-04-01	Recruiting
Dapagliflozin in the Prevention of Post-Coronary Intervention Acute Kidney Injury [NCT05435235]	Phase 4	250 participants (Anticipated)	Interventional	2023-08-31	Suspended(stopped due to Laboratory UNGAL)
A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on [NCT01217892]	Phase 3	400 participants (Actual)	Interventional	2010-11-30	Completed
A Randomized Controlled Trial on SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease [NCT06155604]	Phase 2	150 participants (Anticipated)	Interventional	2023-12-01	Not yet recruiting
An 8-week, Single Centre, Randomized, Parallel-group, Double-blind, Placebo Controlled Phase IV Study to Evaluate Dapagliflozin 10 mg Once Daily Effects on Insulin Resistance in Subjects With Type 2 Diabetes Mellitus [NCT02426541]	Phase 4	55 participants (Actual)	Interventional	2015-03-23	Completed
A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/850 mg) Relative to a 5 mg Dapagliflozin Tablet and an 850 mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects [NCT01535677]	Phase 1	71 participants (Actual)	Interventional	2013-04-30	Completed
A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Da [NCT02229396]	Phase 3	695 participants (Actual)	Interventional	2014-09-04	Completed
A Randomized Study to Evaluate the Metabolic Responses of Adding Dapagliflozin Versus Sitagliptin to Chinese Patients With Type 2 Diabetes Inadequately Controlled With Insulin Therapy (DISTINCTION Study) [NCT03959501]	Phase 4	60 participants (Actual)	Interventional	2017-08-16	Completed
DAPASALT: An Open Label, Phase IV, Mechanistic, Three-Arm Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin Treatment in Type 2 Diabetes Mellitus Patients With Either Preserved or Impaired Renal Function and Non-Diabetics With Impaired Rena [NCT03152084]	Phase 4	24 participants (Actual)	Interventional	2017-07-12	Terminated(stopped due to Poor recruitment.)
Pilot Study to Evaluate the Effect of Inflammation in Heart Failure [NCT05330013]	Phase 2	0 participants (Actual)	Interventional	2022-06-23	Withdrawn(stopped due to PI left NIH)
Real World Observation of SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients With Acute Myocardial Infarction, a Prospective, Multi-center Registry Study [NCT05770687]		1,000 participants (Anticipated)	Observational	2020-08-01	Recruiting
Short-term Effects of Dapagliflozin on Fasting and Postprandial Glucose Homeostasis in Male Type 1 Diabetes Patients. [NCT02211742]	Phase 4	12 participants (Actual)	Interventional	2014-08-31	Completed
Multicenter, Randomized, Controlled Trial to Assess the Efficacy of Sodium Glucose Cotransporter-2 Inhibitor add-on Treatment in Patients With Severe Tricuspid Regurgitation [NCT05686616]		72 participants (Anticipated)	Interventional	2022-04-13	Recruiting
Effectiveness of Dapagliflozin + Saxagliptin to Revert From a Basal-bolus Insulin Treatment (BBIT) Regimen to a Basal Supported Oral Therapy (BOT) in Patients With Type 2 Diabetes [NCT02965443]	Phase 4	4 participants (Actual)	Interventional	2018-02-02	Terminated(stopped due to Low patient recruitment)
A Prospective, Randomized Study of Infusate 2.0 Direct Sodium Removal (DSR) Treatment in Subjects With Chronic Heart Failure (CHF) Induced Persistent Congestion, Resistant to Loop Diuretic Treatment. [NCT05965934]	Phase 1/Phase 2	33 participants (Anticipated)	Interventional	2023-07-07	Recruiting
Replication of the DAPA-CKD (Chronic Kidney Disease) Trial in Healthcare Claims Data [NCT04882813]		87,727 participants (Actual)	Observational	2020-12-13	Completed
Effect of SGLT2 Inhibition on Aging-related Biomarkers in Older Obese Adults With Pre-diabetes [NCT04401904]	Phase 1/Phase 2	20 participants (Actual)	Interventional	2020-06-25	Active, not recruiting
Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion [NCT02113241]	Phase 2/Phase 3	24 participants (Actual)	Interventional	2014-04-30	Completed
Effects of Perioperative Dapagliflozin on Type 2 Diabetic Patients Undergoing Cardiac Surgery [NCT05621551]	Phase 4	178 participants (Anticipated)	Interventional	2022-11-11	Recruiting
Triple Therapy for Type 1 Diabetes With Insulin, Semaglutide, and Dapagliflozin [NCT03899402]	Phase 2/Phase 3	114 participants (Anticipated)	Interventional	2019-05-01	Recruiting
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study [NCT05220917]		781,430 participants (Anticipated)	Observational	2021-08-01	Active, not recruiting
A Multi-centre, Randomised, Double-blind, Placebo-controlled Trial to Determine the Effect of Dapagliflozin 10mg Once Daily on Cardiovascular Outcomes in Haemodialysis for Patients With End Stage Renal Disease (ESRD) [NCT04764097]	Phase 2/Phase 3	0 participants (Actual)	Interventional	2021-06-30	Withdrawn(stopped due to Lack of funding and similar competing study being conducted in Europe.)
Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients: The INFINITI Study [NCT04965935]	Phase 3	52 participants (Anticipated)	Interventional	2021-07-15	Recruiting
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control [NCT05743907]	Phase 4	232 participants (Anticipated)	Interventional	2023-02-28	Not yet recruiting
Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes [NCT02700334]	Phase 4	24 participants (Actual)	Interventional	2016-10-31	Completed
Effect of Sodium-Glucose Co-transporter 2 Inhibitors on Kidney Disease Progression and Bone Mineral Metabolism in Non-diabetic Patients With Chronic Kidney Disease [NCT05735197]	Phase 4	100 participants (Actual)	Interventional	2022-11-10	Active, not recruiting
SGLT-2 Inhibition Using Dapagliflozin During and After Physical Exercise - Effects on Glycemic Variability, Hormonal Regulators of Glucose Homeostasis and Ketone Body in Type 1 Diabetes - a Randomized, Placebo-controlled, Open-label, Cross-over Interventi [NCT04049110]	Phase 3	39 participants (Actual)	Interventional	2020-08-25	Completed
Study of the Effect of Vildagliptin Versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects With Type 2 Diabetes [NCT02475070]	Phase 4	28 participants (Actual)	Interventional	2016-01-31	Completed
Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Forxiga [NCT02561130]	Phase 4	154 participants (Actual)	Interventional	2015-12-31	Completed
mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms (TACTIC-E) [NCT04393246]	Phase 2/Phase 3	454 participants (Actual)	Interventional	2020-07-03	Completed
A Randomized, 2-period, 2-treatment, Single-dose, Crossover Study to Assess the Bioequivalence of the Fixed Dose Combination (FDC) of Dapagliflozin 10 mg and Sitagliptin 100 mg, and Dapagliflozin 10 mg and Sitagliptin 100 mg Administered as Individual Tab [NCT05266404]	Phase 1	46 participants (Actual)	Interventional	2022-03-21	Completed
A Randomized, Open-label Study of Dapagliflozin in Patients With or Without Type 2 Diabetes Admitted With Acute Heart Failure [NCT04298229]	Phase 3	240 participants (Actual)	Interventional	2020-04-01	Completed
A 16-wk, Uni-center, Randomized, Double-blind, Parallel, Phase 3b Trial to Evaluate Efficacy of Saxagliptin + Dapagliflozin vs.Dapagliflozin With Regard to EGP in T2DM With Insufficient Glycemic Control on Metformin+/-Sulfonylurea Therapy [NCT02613897]		56 participants (Actual)	Interventional	2016-01-31	Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Cont [NCT00263276]	Phase 2	389 participants (Actual)	Interventional	2005-12-31	Completed
Natriuretic-ureothelic Adaptation of Body Fluid Homeostasis During SGLT-2 Inhibition and/or Mineralocorticoid Receptor Modulation in Patients With Chronic Kidney Disease. A 4-arm, Double-blind, Double-dummy, Parallel-group, Phase 2 Study to Investigate th [NCT05884866]	Phase 2	150 participants (Anticipated)	Interventional	2023-05-08	Recruiting
Ketone Monitoring in T1D: Effect of SGLT2i During Usual Care and With Insulin Deficiency [NCT05541484]	Phase 4	20 participants (Anticipated)	Interventional	2022-10-14	Recruiting
An Open Label Randomized Control Trial to Compare the Safety and Efficacy of Dapagliflozin Plus Metformin Versus Sitagliptin Plus Metformin for Treatment of Diabetes in Patients With Compensated and Stable Decompensated Cirrhosis [NCT06147518]		240 participants (Anticipated)	Interventional	2023-12-20	Not yet recruiting
A Bioequivalence Study of Fixed-dose Combination Tablet of 5 Milligrams Saxagliptin/10 Milligrams Dapagliflozin Relative to Their Respective Individual Components Coadministered to Healthy Subjects in the Fasted State [NCT02223065]	Phase 1	36 participants (Actual)	Interventional	2014-09-30	Completed
Study of the Cardio Renal Effects of SGLT2 Inhibitors Among Diabetic and Non-diabetic Lupus Nephritis Patients [NCT05748925]	Phase 4	100 participants (Actual)	Interventional	2022-10-01	Active, not recruiting
A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Ha [NCT04356742]	Phase 3	198 participants (Actual)	Interventional	2020-05-26	Completed
Targeting Pediatric Brain Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i) [NCT05521984]	Phase 1	20 participants (Anticipated)	Interventional	2023-04-03	Recruiting
Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders [NCT05792540]	Phase 2	75 participants (Anticipated)	Interventional	2023-06-06	Recruiting
Evaluating the Short-term Renal and Systemic Effects of Dapagliflozin in Non-diabetic Patients With Stage IV CKD at Risk of ESKD Because of Severe Renal Insufficiency and Persistent Proteinuria: A Prospective, Randomized, Double-blind, Placebo-controlled, [NCT04794517]	Phase 2	32 participants (Anticipated)	Interventional	2021-11-08	Recruiting
A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease [NCT05308160]	Phase 3	75 participants (Anticipated)	Interventional	2021-06-28	Recruiting
An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin [NCT02433678]	Phase 4	52 participants (Actual)	Interventional	2015-11-30	Completed
EFFECT OF ADDING DAPAGLIFLOZIN TO ALLOGRAFT DYSFUNCTION OF RENAL TRANSPLANTED PATIENTS: A Prospective, Randomized, Single-blinded, Placebo- Controlled Study. [NCT04743453]	Phase 4	220 participants (Anticipated)	Interventional	2021-08-17	Recruiting
Dapagliflozin to Prevent Atrial Fibrillation Recurrence After Transcatheter Pulmonary Venous Isolation. [NCT04780438]	Early Phase 1	350 participants (Anticipated)	Interventional	2021-09-01	Not yet recruiting
An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin Modified Release Film-coated Tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) Versus the Combined Use of Forxiga™ (Dapagliflozin), [NCT02722239]	Phase 1	40 participants (Actual)	Interventional	2016-03-30	Completed
Effect of Dapagliflozin on Blood Pressure Variability in Patients With Prediabetes and Prehypertension Without Pharmacological Treatment [NCT03006471]	Phase 4	30 participants (Actual)	Interventional	2016-03-30	Completed
Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss? [NCT03180489]	Phase 2	62 participants (Actual)	Interventional	2017-05-03	Completed
A Multicenter Randomized Exploratory Clinical Trial to Evaluate the Effect of Bone Metabolism and the Efficacy of Evogliptin and Dapagliflozin for Blood Sugar in the Menopause Female Patients With Osteopenia and Type 2 Diabetes [NCT04706637]	Phase 4	120 participants (Anticipated)	Interventional	2021-02-01	Not yet recruiting
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training? [NCT02371187]	Phase 2	37 participants (Actual)	Interventional	2015-06-30	Completed
A Randomized, Double-Blind, Placebo-controlled, Single-center, Phase 1 Inpatient Pilot Study to Explore the Safety and Efficacy of DAPAglifozin as Add-on to Day and Night Closed-loop Control in Patients Type 1 Diabetes (T1D) [NCT02987738]	Phase 1	30 participants (Actual)	Interventional	2017-02-09	Completed
The Effect of Dapagliflozin on Inflammation and Endothelial Function [NCT02608905]	Phase 4	17 participants (Actual)	Interventional	2015-11-30	Terminated(stopped due to Due to difficulty with enrollment of subjects)
THE UNIVERSITY of OTTAWA DAPAGLIFLOZIN in STEMI RANDOMIZED CLINICAL TRIAL [NCT06174753]	Phase 3	256 participants (Anticipated)	Interventional	2024-02-29	Not yet recruiting
Dapagliflozin in Patients With Atrial Fibrillation [NCT05174052]	Phase 3	28 participants (Anticipated)	Interventional	2022-06-01	Recruiting
Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy [NCT05797935]	Phase 4	50 participants (Actual)	Interventional	2021-08-01	Completed
Sodium Glucose Cotransporter-2 Inhibitor DAPAgliflozin Versus Thiazide Diuretic in Patients With Heart Failure and Diuretic RESISTance: a Multi-centre, Open-label, Randomised Controlled Clinical Trial [NCT04860011]	Phase 3	61 participants (Actual)	Interventional	2021-04-27	Active, not recruiting
Potential Use of Dapaglifozin to Avoid Acute Kindey Injury (AKI) to Chronic Kidney Disease (CKD) Transition: DAKI-CKD Study [NCT05713851]	Phase 2/Phase 3	100 participants (Anticipated)	Interventional	2023-01-01	Recruiting
PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care [NCT05468203]	Phase 3	3,000 participants (Anticipated)	Interventional	2023-11-29	Recruiting
Replication of the Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Diabetes Trial in Healthcare Claims [NCT04215523]		49,790 participants (Actual)	Observational	2019-07-08	Completed
A Clinical Pharmacology and Long Term Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With Type 1 Diabetes Who Have Inadequate Glycemic Control [NCT02582840]	Phase 1	42 participants (Actual)	Interventional	2015-10-31	Completed
Paradoxical Stimulation of Hepatic Glucose Production With Dapagliflozin (P2) [NCT02984644]	Phase 3	30 participants (Actual)	Interventional	2017-09-06	Completed
Use of Combination Empagliflozin/Linagliptin or Dapagliflozin/Saxagliptin vs Empagliflozin or Dapagliflozin Alone, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections. [NCT04735042]		60 participants (Anticipated)	Observational	2020-10-07	Recruiting
Dapagliflozin Effect on Erythropoiesis and Physical Fitness in Patients With Type 2 Diabetes - a Randomized, Partly Double-blinded, Controlled, Three Armed, Parallel Group, Exploratory Study [NCT03423355]	Phase 4	0 participants (Actual)	Interventional	2021-09-30	Withdrawn(stopped due to change in sponsor)
DAPARHT: DAPAgliflozin for Renal Protection in Heart Transplant Recipients [NCT05321706]	Phase 3	430 participants (Anticipated)	Interventional	2022-06-08	Recruiting
Empagliflozin and Dapagliflozin in Patients Hospitalized for Acute Decompensated Heart Failure (EMPATHY) - a Phase III Trial. [NCT05776043]	Phase 3	1,364 participants (Anticipated)	Interventional	2022-03-15	Recruiting
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial to Evaluate the Effect of In-Hospital Initiation of Dapagliflozin on Clinical Outcomes in Patients Who Have Been Stabilized During Hospitalization for Acute Heart Failure DA [NCT04363697]	Phase 4	2,400 participants (Anticipated)	Interventional	2020-09-24	Recruiting
Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes. A Randomized Clinical Trial [NCT02518945]	Phase 3	30 participants (Anticipated)	Interventional	2015-08-31	Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or Pioglitazone 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapaglif [NCT04885712]	Phase 3	378 participants (Actual)	Interventional	2021-05-28	Completed
A Single-Dose, Bioequivalence, Pivotal Study of Two Formulations of Dapagliflozin 10 mg Tablets Under Fed Conditions [NCT04881006]	Phase 1	30 participants (Actual)	Interventional	2020-12-10	Completed
Effects of Dapagliflozin on Biomarkers, Symptoms and Functional Status in Patients With PRESERVED Ejection Fraction Heart Failure [NCT03030235]	Phase 4	324 participants (Actual)	Interventional	2017-03-01	Completed
A Clinical Pharmacology and Long Term Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With Type 1 Diabetes Who Have Inadequate Glycemic Control [NCT02582814]	Phase 3	151 participants (Actual)	Interventional	2015-10-26	Completed
Effects of Dapagliflozin Compared With Glimepiride on Body Composition in Patients With Type 2 Diabetes Inadequately Controlled With Metformin [NCT02564926]	Phase 4	125 participants (Actual)	Interventional	2016-01-05	Completed
Effects of dapaglifloziN Therapy on Myocardial Perfusion Reserve in Prediabetic Patients With Stable coronarY Artery Disease (ENTRY Trial) [NCT04330079]	Phase 4	2 participants (Actual)	Interventional	2020-05-21	Terminated(stopped due to Slow enrollment. (Difficulty in selecting subjects))
Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery [NCT04340908]	Phase 4	500 participants (Anticipated)	Interventional	2021-01-01	Recruiting
An Exploratory Phase II/III, Randomized, Double-blind, Placebo Controlled, Parallel Design Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Dapagliflozin and Dapagliflozin in Combination With Saxagliptin in CKD Patients With Type 2 Diabetes [NCT02547935]	Phase 2/Phase 3	459 participants (Actual)	Interventional	2015-09-21	Completed
A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination (FDC) Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants (Humacao, Puerto Rico and Mount Vernon, US) in Healthy Subject [NCT03216278]	Phase 1	284 participants (Actual)	Interventional	2017-09-26	Completed
SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Diabetic and Non- Diabetic Lupus Nephritis Patients [NCT05704088]	Phase 4	100 participants (Actual)	Interventional	2022-10-08	Active, not recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Asian Subjects With T2DM and Inadequate Glycemic Control on Metformin and Saxagliptin (DS Navigation) [NCT03608358]	Phase 3	41 participants (Actual)	Interventional	2019-02-27	Terminated(stopped due to Sponsor decided to stop commercialization of QTERNMet/Qtrilmet and to stop all related ongoing activities/studies for business reasons.)
A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Co [NCT02284893]	Phase 3	461 participants (Actual)	Interventional	2014-09-09	Completed
Regulation of Hepatic and Peripheral Glucose Metabolism: Protocol IVA. Effect of Plasma Glucose Reduction by Selective SLGT2 Inhibition on Mitochondrial Dysfunction and Impaired Insulin Signaling/Sensitivity in T2DM [NCT01439854]		18 participants (Actual)	Interventional	2011-03-31	Completed
Effects of Dapagliflozin and Metformin on Vascular Function in Newly-Diagnosed Treatment-Naive Type 2 Diabetes- A Randomised Controlled Trial (DMVascular Study) [NCT05440591]	Phase 4	150 participants (Anticipated)	Interventional	2019-04-01	Recruiting
A Comparison of Postprandial Glucose After a Mixed Meal Tolerance Test, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study of the Dual Systemic SGLT1 and SGLT2 Inhibitor YG1699, and the Selective SGLT2 Inhibitor Dapagliflozin in Subjects [NCT04956263]	Phase 2	19 participants (Actual)	Interventional	2021-06-17	Completed
Single-center, Randomized, Controlled Study to Evaluate the Effects of a Six-month Treatment With Renal Glucose Transport Inhibitor (SGLT2i) Drugs on Markers of Senescence, Inflammation and Tubulointerstitial Damage in the Kidney of Patients With Chronic [NCT05998837]	Phase 2/Phase 3	34 participants (Anticipated)	Interventional	2021-04-13	Recruiting
A Randomized, Double-blind, Comparator-controlled Trial to Assess the Effect of 12-week Treatment With Dapagliflozin Versus Gliclazide on Renal Physiology and Biomarkers in Metformin-treated Patients With Type 2 Diabetes Mellitus [NCT02682563]	Phase 4	44 participants (Actual)	Interventional	2016-02-29	Completed
Safety and Efficacy of Dapagliflozin in Adult Patients With a Systemic Right Ventricle [NCT05717257]	Phase 4	50 participants (Anticipated)	Interventional	2022-08-01	Recruiting
Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss? [NCT02520518]	Phase 2	9 participants (Actual)	Interventional	2015-08-31	Terminated(stopped due to Designed a new modified/simplified protocol see NCT 03180489)
Protocol 2: Elucidation of Mechanisms Responsible for the Increase in EGP Following SGLT2 Inhibition: Decrease in Plasma Glucose Conc or Change in Islet Hormone (Glucagon/Insulin) Secretion [NCT02592421]	Phase 3	30 participants (Actual)	Interventional	2015-10-23	Completed
Effects of Sodium-Glucose Cotransporter 2 Inhibition on the Mechanisms of Cardiac Damage in the Diabetic Patient With Heart Failure With Preserved Ejection Fraction [NCT04739215]	Phase 4	62 participants (Anticipated)	Interventional	2021-01-15	Recruiting
Dapagliflozin on Cholesterol Metabolism in DM2: Dissecting Its Effect on Dyslipidemia by Using Stable Isotope Based Cholesterol and Glucose Fluxes [NCT03074630]	Phase 4	12 participants (Actual)	Interventional	2016-05-31	Completed
SGLT2 INHIBITION AND STIMULATIION OF ENDOGENOUS GLUCOSE PRODUCTION Significance - PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria [NCT03168295]	Phase 4	34 participants (Actual)	Interventional	2016-10-31	Completed
A Multi-Center, Randomized, Double-Blind, Active-Controlled , Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered With Dapagliflozin 5mg Compared to Saxagliptin 5mg or Dapagliflozin 5mg All Given as Add-o [NCT02681094]	Phase 3	905 participants (Actual)	Interventional	2016-02-26	Completed
Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients [NCT05347459]		100 participants (Anticipated)	Observational	2022-03-02	Recruiting
A 16-week Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diab [NCT02157298]	Phase 4	266 participants (Actual)	Interventional	2014-06-30	Completed
Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention [NCT04806633]	Early Phase 1	1,722 participants (Anticipated)	Interventional	2021-04-01	Not yet recruiting
A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus [NCT02597049]	Phase 3	424 participants (Actual)	Interventional	2015-11-30	Completed
Effect of Sodium-dependent Glucose Transporters 2 Inhibitor Dapagliflozin on Ventricular Arrhythmia in Patients With Heart Failure. [NCT05550441]	Phase 4	120 participants (Anticipated)	Interventional	2022-11-15	Not yet recruiting
Effect of Metformin, Dapagliflozin, Fixed Combination of Metformin and Pioglitazone in Overweighted Patients With Newly Diagnosed Type 2 Diabetes [NCT05591235]	Phase 3	60 participants (Anticipated)	Interventional	2022-11-30	Not yet recruiting
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate [NCT00984867]	Phase 3	833 participants (Actual)	Interventional	2009-10-31	Completed
A Single-dose, Open-label, Randomized, 3 Period, 3 Treatment Crossover Study to Evaluate the Pharmacokinetics of Saxagliptin 5 mg and Dapagliflozin 10 mg When Coadministered to Fasted Healthy Subjects [NCT01662999]	Phase 1	42 participants (Actual)	Interventional	2012-08-31	Completed
A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Mild [NCT02532855]	Phase 3	614 participants (Actual)	Interventional	2015-10-20	Completed
The Effects of Dapagliflozin on HDL Particles Subtypes and Reverse Cholesterol Transport in Type 2 Diabetic Patients. A 12 Weeks Randomized Placebo-controlled Phase IV Study [NCT02327039]	Phase 4	33 participants (Actual)	Interventional	2015-03-31	Completed
Effects of DPP4 Inhibitor Versus SGLT2 Inhibitor on Ischemic Burden in Stable Ischemic Heart Disease Patients [NCT03178591]	Phase 4	43 participants (Actual)	Interventional	2014-10-31	Completed
Research Into the Effect of SGLT2 Inhibition on Left Ventricular Remodeling in Patients With Heart Failure and Diabetes Mellitus [NCT02397421]	Phase 4	56 participants (Actual)	Interventional	2015-03-31	Completed
A Phase 1 Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination of DW6012 and Loose-combination of Each Component in Healthy Adult Volunteers [NCT05403281]	Phase 1	41 participants (Actual)	Interventional	2021-11-05	Completed
Evaluation of the Efficacy of Combination of Dapagliflozin and Lobeglitazone on Glucose Concentrations and Body Fat in Patients With Type 2 Diabetes [NCT05915949]	Phase 4	99 participants (Anticipated)	Interventional	2022-01-01	Recruiting
The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study [NCT04818034]	Phase 2	10 participants (Anticipated)	Interventional	2025-05-02	Recruiting
Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation (DAPA-AF) Prospective, Randomized, Multicenter, Placebo-Controlled Trial [NCT04792190]	Phase 4	25 participants (Actual)	Interventional	2021-07-27	Completed
Impact of Dapagliflozin on Vascular Function in Chronic Kidney Disease Patients [NCT04930549]	Phase 2	54 participants (Anticipated)	Interventional	2021-12-31	Not yet recruiting
A Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus [NCT01525238]	Phase 1	53 participants (Actual)	Interventional	2012-07-01	Completed
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus - Study Two [NCT02460978]	Phase 3	815 participants (Actual)	Interventional	2015-07-08	Completed
Alpelisib, Fulvestrant and Dapagliflozin for the Treatment of HR+, HER2 -, PIK3CA Mutant Metastatic Breast Cancer [NCT05025735]	Phase 2	25 participants (Anticipated)	Interventional	2021-08-25	Recruiting
Randomized, Double-blind, Multicenter, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus [NCT03766750]	Phase 3	0 participants (Actual)	Interventional	2021-12-31	Withdrawn(stopped due to Sponsor decision)
Effect of Dapagliflozin on Left Ventricular Remodeling in Patients With Acute Myocardial Infarction [NCT04783870]	Phase 4	60 participants (Anticipated)	Interventional	2021-03-03	Recruiting
A Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Explore the Safety, Pharmacokinetics and Pharmacodynamics of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus [NCT01498185]	Phase 2	171 participants (Actual)	Interventional	2012-02-29	Completed
A Multicenter, Randomized, Open-label, Two-arm, Phase 4 Study to Evaluate the Effect of Add-on Pioglitazone or Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled by Dipeptidyl Peptidase-4 Inhibitor and Metformin Therapy [NCT03499704]	Phase 4	133 participants (Actual)	Interventional	2020-02-11	Active, not recruiting
Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in [NCT01730534]	Phase 3	17,190 participants (Actual)	Interventional	2013-04-25	Completed
A Study to Assess the Effects of the Endothelin Receptor Antagonist Zibotentan and the SGLT2 Inhibitor Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria: a Randomized Double Blind Cross-Over Trial [NCT05570305]	Phase 2	38 participants (Anticipated)	Interventional	2022-10-06	Enrolling by invitation
The Hepato-protective Effect of Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD) [NCT05459701]	Phase 4	50 participants (Anticipated)	Interventional	2022-05-01	Recruiting
Acute Effect of Dapagliflozin vs Empagliflozin Administration on Flow Mediated Dilation in Patients With Type 2 Diabetes Mellitus [NCT04195243]	Phase 3	24 participants (Anticipated)	Interventional	2019-12-02	Not yet recruiting
Efficacy and Safety of Dapagliflozin in Non-alcoholic Steatohepatitis: a Multicentre, Randomized, Placebo-controlled Trial [NCT03723252]	Phase 3	148 participants (Anticipated)	Interventional	2019-03-20	Active, not recruiting
Acute Effect of Empagliflozin vs Dapagliflozin vs Placebo Administration Over Pulse Wave Velocity in Patients With Type Two Diabetes [NCT05109949]	Phase 3	72 participants (Actual)	Interventional	2020-03-30	Active, not recruiting
A Single-Dose, Bioequivalence, Pivotal Study of Two Formulations of Dapagliflozin 10 mg Tablets Under Fasting Conditions [NCT04880993]	Phase 1	30 participants (Actual)	Interventional	2020-12-14	Completed
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Cross-over Design Clinical Trial to Evaluate the Safety and Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers [NCT04856969]	Phase 1	38 participants (Actual)	Interventional	2021-03-30	Completed
Effect of the Antidiabetic Drug DAPAgliflozin on the Coronary Macrovascular and MICROvascular Function in Type 2 Diabetic Patients [NCT05392959]	Phase 4	100 participants (Anticipated)	Interventional	2022-06-06	Recruiting
A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants in Healthy Subjects Under Fasting and Fed Conditions [NCT02637037]	Phase 1	80 participants (Actual)	Interventional	2015-12-21	Completed
Sodium Glucose Co-Transporter 2 (SGLT2) Inhibition Improves Left Ventricular Function and Reduces Adverse Left-Ventricular Remodeling in High-Risk Patients With Microvascular Obstruction (MVO) Following ST-elevation Myocardial Infarction (STEMI). [NCT05305911]	Phase 2	80 participants (Anticipated)	Interventional	2022-08-03	Recruiting
Evaluation of the Effect of Dapagliflozin on Cardiac Remodeling in Post Myocardial Infarction Patients [NCT05335629]		60 participants (Anticipated)	Interventional	2022-09-01	Recruiting
A 24-week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate Efficacy and Safety of Dapagliflozin Added to Therapy of Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin [NCT02096705]	Phase 3	477 participants (Actual)	Interventional	2014-03-31	Completed
Dapagliflozin Effect in Cognitive Impairment in Stroke Trial [NCT05565976]	Phase 2/Phase 3	270 participants (Anticipated)	Interventional	2020-08-01	Recruiting
Combined Effects of SGLT2 Inhibition and GLP-1 Receptor Agonism on Food Intake, Body Weight and Central Satiety and Reward Circuits in Obese T2DM Patients [NCT03361098]	Phase 4	65 participants (Actual)	Interventional	2017-09-18	Completed
Effect of Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor on Systemic and Renal Endothelial Function in Patients With Type 2 Diabetes Mellitus Without History of Coronary Artery Disease (SOCCER Trial) [NCT02501616]	Phase 4	22 participants (Anticipated)	Interventional	2014-12-31	Recruiting
The Effect of Sodium Glucose Co-transporter 2 Inhibitor (Dapagliflozin) on Weight Loss in Non-diabetic Adults With Obesity: Triple-blinded, Randomized, Placebo-controlled Trial. [NCT06000462]	Phase 2/Phase 3	150 participants (Anticipated)	Interventional	2023-12-31	Not yet recruiting
Study on the Effect of Dapagliflozin on Myocardial Insulin Sensitivity and Perfusion [NCT03313752]	Phase 3	52 participants (Anticipated)	Interventional	2017-12-01	Recruiting
Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus With Continuous Glucose Monitoring System [NCT04120623]	Phase 4	100 participants (Anticipated)	Interventional	2019-10-01	Not yet recruiting
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combinatio [NCT01606007]	Phase 3	1,282 participants (Actual)	Interventional	2012-07-31	Completed
Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes [NCT03269058]	Phase 4	28 participants (Anticipated)	Interventional	2017-12-20	Recruiting
Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility Study [NCT06111768]	Phase 2	60 participants (Anticipated)	Interventional	2023-12-31	Not yet recruiting
Multicentre Prospective Open Label Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy. [NCT04662723]	Phase 4	878 participants (Anticipated)	Interventional	2023-05-01	Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxag [NCT01646320]	Phase 3	320 participants (Actual)	Interventional	2012-09-30	Completed
Effects of Dapagliflozin on Blood Volume Status and Vascular Function in Clinically Compensated Heart Failure Patients After an Acute Heart Failure Event. [NCT04869124]	Phase 4	80 participants (Anticipated)	Interventional	2021-02-15	Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus [NCT02268214]	Phase 3	833 participants (Actual)	Interventional	2014-11-11	Completed
A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy and Safety of Dapagliflozin as Monotherapy Compared With Acarbose in Drug-Naive Patients With Type 2 Diabetes Mellitus (T2DM) in China [NCT03344341]	Phase 4	304 participants (Actual)	Interventional	2017-12-15	Terminated(stopped due to Study overall progress behind of scheduled timeline. Study was terminated early due to company decision.)
Therapeutic Response of Sodium-glucose Co-transporter Type-2 Inhibitor in Non-diabetic MAFLD Patients: a Pilot Study [NCT05782972]	Phase 4	50 participants (Anticipated)	Interventional	2023-03-11	Recruiting
A Study Comparing Exposure of Semaglutide and Dapagliflozin Dosed Orally as Mono-components Versus in a Fixed-dose Combination [NCT05429593]	Phase 1	152 participants (Actual)	Interventional	2022-06-22	Completed
Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes [NCT02235298]	Phase 4	100 participants (Actual)	Interventional	2015-09-30	Completed
A Prospective, Randomized, Double-blind, Multicenter Study on the Association Between Dapagliflozin-induced Improvement and Anemia in Heart Failure Patients (ADIDAS) [NCT04707261]	Phase 4	1,990 participants (Anticipated)	Interventional	2021-08-06	Recruiting
The Effect of Dapagliflozin on Ultrafiltration Among Peritoneal Dialysis Patients [NCT04923295]		20 participants (Actual)	Interventional	2021-06-02	Completed
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin [NCT02429258]	Phase 4	226 participants (Actual)	Interventional	2015-05-31	Completed
Effect of Dapagliflozin on Cardio-Metabolic Risk Factors in Patients With Type-2 Diabetes [NCT03377335]	Phase 4	186 participants (Anticipated)	Interventional	2017-12-22	Active, not recruiting
A Phase 1, Open-label Study With Two Independent Parts: Collecting Samples for Metabolites in Safety Testing Analysis of Zibotentan After Repeated Administration (Part 1); and a Randomised, Cross-over, Three Period, Three-treatment, Single Dose Study to A [NCT04991571]	Phase 1	27 participants (Actual)	Interventional	2021-07-29	Completed
Dose Rationale for Dapagliflozin and Empagliflozin in Paediatric Heart Failure: a Phase II.a Pharmacokinetics, Ease-of-swallow, Safety and Proof-of-concept Study Among Children 6-18 Years of Age [NCT06012266]	Phase 2	12 participants (Anticipated)	Interventional	2024-01-31	Not yet recruiting
Retrospective and Multicenter Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain [NCT04149067]		1,080 participants (Actual)	Observational	2017-06-05	Completed
Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure [NCT02653482]	Phase 4	263 participants (Actual)	Interventional	2016-03-03	Completed
National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus [NCT05886088]	Phase 3	597 participants (Anticipated)	Interventional	2024-02-29	Not yet recruiting
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added t [NCT01619059]	Phase 3	315 participants (Actual)	Interventional	2012-06-30	Completed
An Open-Label, Non-randomized, Multi-center Pilot Study to Evaluate the Safety and Efficacy of 4-week, Daily Oral Use of Dapagliflozin 10mg Tablet in Adults With a Fontan Circulation [NCT05741658]	Phase 4	29 participants (Anticipated)	Interventional	2023-11-08	Enrolling by invitation
Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration [NCT02911792]	Phase 4	72 participants (Actual)	Interventional	2016-12-20	Completed
A Phase I, Randomized, Double-blind, Placebo- and Active-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of DWP16001 Following Oral Administration in Healthy Male V [NCT03364985]	Phase 1	123 participants (Actual)	Interventional	2017-12-03	Completed
Effect of Dapagliflozin on Glycemic Variability as an add-on Therapy in Subjects With Type 2 Diabetes Mellitus With in Inadequate Glycemic Control in Insulin: a Multicenter, Placebo-controlled, Double-blind, Randomized Study [NCT02459353]	Phase 4	86 participants (Actual)	Interventional	2015-08-31	Completed
"A Randomized, Open-label, Single Dose, Two-way Crossover Phase 1 Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR3003 and Co-administration of BR3003B and BR3003C in Healthy Volunteers." [NCT05411965]	Phase 1	48 participants (Actual)	Interventional	2022-04-28	Completed
A Double-blind Randomized Placebo-controlled, Parallel-group 12 Week Study to Investigate the Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Type 2 Diabetic Patients; EFFECT II [NCT02279407]	Phase 2	223 participants (Actual)	Interventional	2015-01-31	Completed
A Randomized Study Evaluating Dapagliflozin and Metformin, Alone and in Combination, in Overweight Women With a Recent History of Gestational Diabetes Mellitus: Effects on Anthropometric Measurements and Cardiometabolic Abnormalities [NCT02338193]	Phase 3	69 participants (Actual)	Interventional	2015-09-22	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00357370 (6) [back to overview]	Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
NCT00357370 (6) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
NCT00357370 (6) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
NCT00357370 (6) [back to overview]	Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2
NCT00357370 (6) [back to overview]	Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
NCT00357370 (6) [back to overview]	Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2
NCT00528372 (17) [back to overview]	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)
NCT00528372 (17) [back to overview]	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2
NCT00528372 (17) [back to overview]	Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00528372 (17) [back to overview]	Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])
NCT00528372 (17) [back to overview]	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)
NCT00528372 (17) [back to overview]	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1
NCT00528372 (17) [back to overview]	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)
NCT00528372 (17) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1
NCT00528372 (17) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2
NCT00528372 (17) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
NCT00528372 (17) [back to overview]	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2
NCT00528372 (17) [back to overview]	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])
NCT00528372 (17) [back to overview]	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1
NCT00528372 (17) [back to overview]	Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)
NCT00528372 (17) [back to overview]	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1
NCT00528372 (17) [back to overview]	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])
NCT00528372 (17) [back to overview]	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2
NCT00528879 (15) [back to overview]	Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])
NCT00528879 (15) [back to overview]	Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality
NCT00528879 (15) [back to overview]	Number of Participants With Orthostatic Hypotension
NCT00528879 (15) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])
NCT00528879 (15) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
NCT00528879 (15) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
NCT00528879 (15) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
NCT00528879 (15) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])
NCT00528879 (15) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
NCT00528879 (15) [back to overview]	Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])
NCT00528879 (15) [back to overview]	Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
NCT00528879 (15) [back to overview]	Mean Changes From Baseline in Seated Diastolic Blood Pressure
NCT00528879 (15) [back to overview]	Mean Changes From Baseline in Seated Systolic Blood Pressure
NCT00528879 (15) [back to overview]	Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation
NCT00528879 (15) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00643851 (6) [back to overview]	Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
NCT00643851 (6) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
NCT00643851 (6) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF])
NCT00643851 (6) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00643851 (6) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00643851 (6) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00660907 (4) [back to overview]	Adjusted Mean Change in Body Weight
NCT00660907 (4) [back to overview]	Adjusted Mean Change in HbA1c Levels
NCT00660907 (4) [back to overview]	Proportion of Participants With Body Weight Reduction of at Least 5%
NCT00660907 (4) [back to overview]	Proportion of Participants With at Least One Episode of Hypoglycemia
NCT00663260 (3) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00663260 (3) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]
NCT00663260 (3) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00673231 (6) [back to overview]	Proportion of Participants With Lack of Glycemic Control
NCT00673231 (6) [back to overview]	Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction
NCT00673231 (6) [back to overview]	Adjusted Mean Change in HbA1c Levels
NCT00673231 (6) [back to overview]	Adjusted Mean Change in Fasting Plasma Glucose (FPG)
NCT00673231 (6) [back to overview]	Adjusted Mean Change in Calculated Mean Daily Insulin Dose
NCT00673231 (6) [back to overview]	Adjusted Mean Change in Body Weight
NCT00680745 (6) [back to overview]	Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
NCT00680745 (6) [back to overview]	Adjusted Mean Change in HbA1c Levels
NCT00680745 (6) [back to overview]	Adjusted Mean Change in Fasting Plasma Glucose (FPG)
NCT00680745 (6) [back to overview]	Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2
NCT00680745 (6) [back to overview]	Adjusted Mean Change in Body Weight
NCT00680745 (6) [back to overview]	Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise
NCT00683878 (7) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00683878 (7) [back to overview]	Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
NCT00683878 (7) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00683878 (7) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
NCT00683878 (7) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00683878 (7) [back to overview]	Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00683878 (7) [back to overview]	Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF])
NCT00736879 (12) [back to overview]	Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants
NCT00736879 (12) [back to overview]	Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
NCT00736879 (12) [back to overview]	Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
NCT00736879 (12) [back to overview]	Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
NCT00736879 (12) [back to overview]	Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants
NCT00736879 (12) [back to overview]	Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants
NCT00736879 (12) [back to overview]	Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants
NCT00736879 (12) [back to overview]	Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants
NCT00736879 (12) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
NCT00736879 (12) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants
NCT00736879 (12) [back to overview]	Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants
NCT00736879 (12) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
NCT00831779 (2) [back to overview]	Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])
NCT00831779 (2) [back to overview]	Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])
NCT00855166 (7) [back to overview]	Adjusted Mean Change in Body Fat Mass
NCT00855166 (7) [back to overview]	Adjusted Mean Change in Total Body Weight
NCT00855166 (7) [back to overview]	Adjusted Mean Change in Waist Circumference
NCT00855166 (7) [back to overview]	Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck
NCT00855166 (7) [back to overview]	Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)
NCT00855166 (7) [back to overview]	Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip
NCT00855166 (7) [back to overview]	Proportion of Participants With Body Weight Decrease ≥5%
NCT00859898 (12) [back to overview]	Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
NCT00859898 (12) [back to overview]	Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants
NCT00859898 (12) [back to overview]	Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants
NCT00859898 (12) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants
NCT00859898 (12) [back to overview]	Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
NCT00859898 (12) [back to overview]	Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants
NCT00859898 (12) [back to overview]	The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants
NCT00859898 (12) [back to overview]	Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants
NCT00859898 (12) [back to overview]	Mean Change From Baseline in Seated Heart Rate at Week 24 - Randomized, Treated Participants
NCT00859898 (12) [back to overview]	Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0%
NCT00859898 (12) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants
NCT00859898 (12) [back to overview]	Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
NCT00972244 (3) [back to overview]	Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
NCT00972244 (3) [back to overview]	Adjusted Mean Change in Fasting Plasma Glucose
NCT00972244 (3) [back to overview]	Adjusted Mean Change in HbA1c Levels
NCT00976495 (4) [back to overview]	Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])
NCT00976495 (4) [back to overview]	Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
NCT00976495 (4) [back to overview]	Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
NCT00976495 (4) [back to overview]	Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])
NCT00984867 (7) [back to overview]	Adjusted Mean Change in Body Weight
NCT00984867 (7) [back to overview]	Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline
NCT00984867 (7) [back to overview]	Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg
NCT00984867 (7) [back to overview]	Adjusted Mean Change in HbA1c Levels
NCT00984867 (7) [back to overview]	Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%
NCT00984867 (7) [back to overview]	Adjusted Mean Change in Fasting Plasma Glucose (FPG)
NCT00984867 (7) [back to overview]	Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise
NCT01031680 (6) [back to overview]	Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²
NCT01031680 (6) [back to overview]	Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
NCT01031680 (6) [back to overview]	Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)
NCT01031680 (6) [back to overview]	Adjusted Mean Change in HbA1c Levels
NCT01031680 (6) [back to overview]	Adjusted Mean Percent Change in Body Weight
NCT01031680 (6) [back to overview]	Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)
NCT01042977 (7) [back to overview]	Adjusted Mean Change in HbA1c Levels
NCT01042977 (7) [back to overview]	Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit
NCT01042977 (7) [back to overview]	Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²
NCT01042977 (7) [back to overview]	Adjusted Mean Percent Change in Body Weight
NCT01042977 (7) [back to overview]	Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)
NCT01042977 (7) [back to overview]	Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)
NCT01042977 (7) [back to overview]	Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg
NCT01095653 (5) [back to overview]	Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])
NCT01095653 (5) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
NCT01095653 (5) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
NCT01095653 (5) [back to overview]	Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
NCT01095653 (5) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
NCT01095666 (5) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
NCT01095666 (5) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
NCT01095666 (5) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
NCT01095666 (5) [back to overview]	Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])
NCT01095666 (5) [back to overview]	Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
NCT01137474 (6) [back to overview]	Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12
NCT01137474 (6) [back to overview]	Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12
NCT01137474 (6) [back to overview]	Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])
NCT01137474 (6) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12
NCT01137474 (6) [back to overview]	Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)
NCT01137474 (6) [back to overview]	Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12
NCT01195662 (11) [back to overview]	Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants
NCT01195662 (11) [back to overview]	Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue
NCT01195662 (11) [back to overview]	Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue
NCT01195662 (11) [back to overview]	Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue
NCT01195662 (11) [back to overview]	Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue
NCT01195662 (11) [back to overview]	Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue
NCT01195662 (11) [back to overview]	Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants
NCT01195662 (11) [back to overview]	Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants
NCT01195662 (11) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants
NCT01195662 (11) [back to overview]	Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)
NCT01195662 (11) [back to overview]	Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)
NCT01217892 (5) [back to overview]	Adjusted Mean Change in HbA1c Levels
NCT01217892 (5) [back to overview]	Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
NCT01217892 (5) [back to overview]	Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1
NCT01217892 (5) [back to overview]	Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.
NCT01217892 (5) [back to overview]	Adjusted Percent Change in Body Weight
NCT01294423 (3) [back to overview]	Adjusted Mean Change in Body Weight
NCT01294423 (3) [back to overview]	Adjusted Mean Change in Fasting Plasma Glucose (FPG)
NCT01294423 (3) [back to overview]	Adjusted Mean Change in HbA1c Levels
NCT01294436 (14) [back to overview]	Mean Change in Magnesium
NCT01294436 (14) [back to overview]	Mean Change in Seated Diastolic Blood Pressure
NCT01294436 (14) [back to overview]	Mean Change in Seated Heart Rate
NCT01294436 (14) [back to overview]	Mean Change in Blood Urea Nitrogen (BUN)
NCT01294436 (14) [back to overview]	Mean Change in Alanine Aminotransferase (ALT)
NCT01294436 (14) [back to overview]	Mean Change in Body Weight
NCT01294436 (14) [back to overview]	Mean Change in Aspartate Aminotransferase (AST)
NCT01294436 (14) [back to overview]	Mean Change in HbA1c Levels
NCT01294436 (14) [back to overview]	Mean Change in Serum Uric Acid
NCT01294436 (14) [back to overview]	Mean Change in Seated Systolic Blood Pressure
NCT01294436 (14) [back to overview]	Mean Change in Hematocrit
NCT01294436 (14) [back to overview]	Proportion of Participants With At Least One Episode of Hypoglycemia
NCT01294436 (14) [back to overview]	Proportion of Participants With Adverse Events
NCT01294436 (14) [back to overview]	Proportion of Participants With Serious Adverse Events
NCT01392677 (5) [back to overview]	Adjusted Mean Change From Baseline in FPG
NCT01392677 (5) [back to overview]	Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure
NCT01392677 (5) [back to overview]	Adjusted Mean Change From Baseline in HbA1c Levels
NCT01392677 (5) [back to overview]	Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)
NCT01392677 (5) [back to overview]	Adjusted Mean Change From Baseline in Total Body Weight
NCT01439854 (2) [back to overview]	Change in Mitochondrial Function
NCT01439854 (2) [back to overview]	Change in Insulin Sensitivity
NCT01498185 (8) [back to overview]	Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)
NCT01498185 (8) [back to overview]	Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)
NCT01498185 (8) [back to overview]	Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU]
NCT01498185 (8) [back to overview]	Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7
NCT01498185 (8) [back to overview]	Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])
NCT01498185 (8) [back to overview]	Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)
NCT01498185 (8) [back to overview]	Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)
NCT01498185 (8) [back to overview]	Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])
NCT01525238 (20) [back to overview]	Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin
NCT01525238 (20) [back to overview]	Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide
NCT01525238 (20) [back to overview]	Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin
NCT01525238 (20) [back to overview]	Mean Plasma Half-life (T-HALF) of Dapagliflozin
NCT01525238 (20) [back to overview]	Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide
NCT01525238 (20) [back to overview]	Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin
NCT01525238 (20) [back to overview]	Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide
NCT01525238 (20) [back to overview]	Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.
NCT01525238 (20) [back to overview]	Number of Participants With Marked Urinalysis Abnormalities
NCT01525238 (20) [back to overview]	Number of Participants With Marked Hematology Laboratory Abnormalities
NCT01525238 (20) [back to overview]	Number of Participants With Marked Abnormalities in Other Chemistry Testing
NCT01525238 (20) [back to overview]	Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting
NCT01525238 (20) [back to overview]	Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide
NCT01525238 (20) [back to overview]	Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin
NCT01525238 (20) [back to overview]	Mean Total Amount of Glucose Excreted in Urine Over 24 Hours
NCT01525238 (20) [back to overview]	Mean Change in Fasting Plasma Glucose From Baseline Until Day 2
NCT01525238 (20) [back to overview]	Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide
NCT01525238 (20) [back to overview]	Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin
NCT01525238 (20) [back to overview]	Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin
NCT01525238 (20) [back to overview]	Number of Participants With Marked Serum Chemistry Abnormalities
NCT01606007 (5) [back to overview]	Adjusted Mean Change From Baseline in Body Weight at Week 24
NCT01606007 (5) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
NCT01606007 (5) [back to overview]	Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
NCT01606007 (5) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24
NCT01606007 (5) [back to overview]	Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])
NCT01619059 (4) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24
NCT01619059 (4) [back to overview]	Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24
NCT01619059 (4) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24
NCT01619059 (4) [back to overview]	Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
NCT01646320 (5) [back to overview]	Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
NCT01646320 (5) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24
NCT01646320 (5) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24
NCT01646320 (5) [back to overview]	Adjusted Mean Change From Baseline in Body Weight at Week 24
NCT01646320 (5) [back to overview]	Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24
NCT01662999 (26) [back to overview]	Plasma Apparent Clearance (CLT/F) of a Single Dose of Dapagliflozin Versus CLT/F of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population
NCT01662999 (26) [back to overview]	Mean Change From Baseline in Temperature - Safety Population
NCT01662999 (26) [back to overview]	Mean Change From Baseline in Respiration Rate - Safety Population
NCT01662999 (26) [back to overview]	Mean Change From Baseline in Heart Rate - Safety Population
NCT01662999 (26) [back to overview]	Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin From a Single Dose of Dapagliflozin Versus Cmax of Dapagliflozin From Co-administered Saxagliptin Plus Dapagliflozin - Pharmacokinetic Evaluable Population
NCT01662999 (26) [back to overview]	Maximum Observed Concentration (Cmax) of a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population
NCT01662999 (26) [back to overview]	Half-life (T-HALF) of Dapagliflozin From a Single Dose of Dapagliflozin Versus T-Half of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population
NCT01662999 (26) [back to overview]	Cmax of the Saxagliptin Total Active Moiety From a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population
NCT01662999 (26) [back to overview]	Cmax of 5-Hydroxy (5-OH) Saxagliptin From a Single Dose Saxagliptin Versus Cmax of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population
NCT01662999 (26) [back to overview]	AUC(INF) of Saxagliptin From a Single Dose of 5 mg Saxagliptin Versus AUC(INF) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population
NCT01662999 (26) [back to overview]	AUC(INF) of 5-OH Saxagliptin From a Single Dose Saxagliptin Versus AUC(INF) of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population
NCT01662999 (26) [back to overview]	AUC(0-T) of Saxagliptin From Single Dose 5 mg Saxagliptin Versus AUC(0-T) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population
NCT01662999 (26) [back to overview]	AUC(0-T) of 5-OH Saxagliptin From Single Dose Saxagliptin Versus AUC(0-T) of 5-OH From Saxagliptin Co-administered With Dapagliflozin - PK Evaluable Population
NCT01662999 (26) [back to overview]	Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus AUC(0-T) for Dapagliflozin When Co-administered With 5 mg Saxagliptin
NCT01662999 (26) [back to overview]	Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity [AUC(INF)] of Dapagliflozin From a Single Dose of Dapagliflozin Versus AUC (INF) of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population
NCT01662999 (26) [back to overview]	Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus Tmax of Dapagliflozin When Co-administered With 5 mg Saxagliptin - PK Evaluable Population
NCT01662999 (26) [back to overview]	AUC(INF) and AUC(0-T) of the Saxagliptin Total Active Moiety From a Single Dose 5 mg Saxagliptin Versus AUC(INF) and AUC(0-T) of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population
NCT01662999 (26) [back to overview]	Tmax of Saxagliptin, 5-OH Saxagliptin, Saxagliptin Total Active Moiety From a Single Dose of Saxagliptin Versus Tmax of Saxagliptin, 5-OH, Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population
NCT01662999 (26) [back to overview]	Number of Participants With Marked Urinalysis Laboratory Abnormalities - Safety Population
NCT01662999 (26) [back to overview]	Number of Participants With Marked Hematology Laboratory Abnormalities - Safety Population
NCT01662999 (26) [back to overview]	Number of Participants With Marked Chemistry Laboratory Abnormalities - Safety Population
NCT01662999 (26) [back to overview]	Number of Participants With Deaths, Serious Adverse Events, Adverse Events, or Discontinuations Due to Adverse Events - Safety Population
NCT01662999 (26) [back to overview]	Number of Participants With Change From Baseline in ECG Interval - Safety Population
NCT01662999 (26) [back to overview]	Metabolite to Parent Molar Ratios (MR) of Cmax, AUC(INF), and AUC(0-T) of 5-OH Saxagliptin and Saxagliptin From a Single Dose 5 mg Saxagliptin Versus MR of Saxagliptin and 5-OH When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable
NCT01662999 (26) [back to overview]	Mean Change From Baseline in Systolic and Diastolic Blood Pressure - Safety Population
NCT01662999 (26) [back to overview]	Half-life (T-HALF) of Saxagliptin, and 5-OH Saxagliptin From Single Dose 5 mg Saxagliptin Versus T-HALF of Saxagliptin and 5-OH From Co-administered Saxagliptin With 10 mg Dapagliflozin - PK Evaluable Population
NCT02096705 (4) [back to overview]	Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24
NCT02096705 (4) [back to overview]	Adjusted Mean Change in Body Weight From Baseline to Week 24
NCT02096705 (4) [back to overview]	Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
NCT02096705 (4) [back to overview]	Adjusted Mean Change in HbA1c From Baseline to Week 24
NCT02113241 (24) [back to overview]	Alanine Aminotransferase (ALT) at Week 12.
NCT02113241 (24) [back to overview]	Waist Circumference at Week 12.
NCT02113241 (24) [back to overview]	Glucose at Minute 90 at Week 12.
NCT02113241 (24) [back to overview]	Triglycerides Levels at Week 12.
NCT02113241 (24) [back to overview]	Insulinogenic Index (Total Insulin Secretion) at Week 12.
NCT02113241 (24) [back to overview]	Fat Mass at Week 12.
NCT02113241 (24) [back to overview]	Glucose at Minute 120 at Week 12.
NCT02113241 (24) [back to overview]	Glucose Levels at Minute 0 at Week 12.
NCT02113241 (24) [back to overview]	Glucose at Minute 30 at Week 12.
NCT02113241 (24) [back to overview]	Glucose at Minute 60 at Week 12.
NCT02113241 (24) [back to overview]	AUC of Insulin at Week 12.
NCT02113241 (24) [back to overview]	AUC of Glucose at Week 12.
NCT02113241 (24) [back to overview]	Low Density Lipoproteins (c-LDL) at Week 12
NCT02113241 (24) [back to overview]	Aspartate Aminotransferase (AST) at Week 12.
NCT02113241 (24) [back to overview]	High Density Lipoprotein (c-HDL) Levels at Week 12.
NCT02113241 (24) [back to overview]	Matsuda Index (Total Insulin Sensitivity) at Week 12.
NCT02113241 (24) [back to overview]	Stumvoll Index (First Phase of Insulin Secretion) at Week 12.
NCT02113241 (24) [back to overview]	Systolic Blood Pressure at Week 12.
NCT02113241 (24) [back to overview]	Total Cholesterol at Week 12
NCT02113241 (24) [back to overview]	Body Weight at Week 12.
NCT02113241 (24) [back to overview]	Creatinine at Week 12.
NCT02113241 (24) [back to overview]	Diastolic Blood Pressure at Week 12.
NCT02113241 (24) [back to overview]	Body Mass Index at Week 12
NCT02113241 (24) [back to overview]	Uric Acid at Week 12.
NCT02157298 (5) [back to overview]	Total Body Weight
NCT02157298 (5) [back to overview]	Total Mean Daily Insulin Dose
NCT02157298 (5) [back to overview]	Proportion of Participants With Mean Daily Insulin Dose Reduction of Greater Than or Equal 10%
NCT02157298 (5) [back to overview]	Adjusted Mean Change in HbA1c Levels
NCT02157298 (5) [back to overview]	Fasting Plasma Glucose
NCT02223065 (6) [back to overview]	Dapagliflozin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])
NCT02223065 (6) [back to overview]	Dapagliflozin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])
NCT02223065 (6) [back to overview]	Dapagliflozin Maximum Observed Concentrations (Cmax)
NCT02223065 (6) [back to overview]	Saxagliptin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])
NCT02223065 (6) [back to overview]	Saxagliptin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])
NCT02223065 (6) [back to overview]	Saxagliptin Maximum Observed Concentrations (Cmax)
NCT02229396 (8) [back to overview]	Change in Body Weight From Baseline to Week 28
NCT02229396 (8) [back to overview]	Change in Fasting Plasma Glucose From Baseline to Week 2
NCT02229396 (8) [back to overview]	Change in Fasting Plasma Glucose From Baseline to Week 28
NCT02229396 (8) [back to overview]	Change in HbA1c From Baseline to Week 28
NCT02229396 (8) [back to overview]	Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test
NCT02229396 (8) [back to overview]	Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28
NCT02229396 (8) [back to overview]	Percentage of Patients Achieving HbA1c <7% at Week 28
NCT02229396 (8) [back to overview]	Change in Systolic Blood Pressure From Baseline to Week 28
NCT02235298 (2) [back to overview]	Left Ventricular Mass (LVM)
NCT02235298 (2) [back to overview]	Epicardial Fat Thickness
NCT02268214 (6) [back to overview]	Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24
NCT02268214 (6) [back to overview]	Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24
NCT02268214 (6) [back to overview]	Adjusted Mean Change in HbA1c From Baseline at Week 24
NCT02268214 (6) [back to overview]	Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24
NCT02268214 (6) [back to overview]	Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24
NCT02268214 (6) [back to overview]	Adjusted Mean Percent Change in Body Weight From Baseline at Week 24
NCT02279407 (2) [back to overview]	Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)
NCT02279407 (2) [back to overview]	Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)
NCT02284893 (4) [back to overview]	Mean Change in HbA1c
NCT02284893 (4) [back to overview]	Mean Change in Total Body Weight
NCT02284893 (4) [back to overview]	Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%
NCT02284893 (4) [back to overview]	Mean Change in Fasting Plasma Glucose (FPG)
NCT02338193 (16) [back to overview]	Waist Circumference (WC)
NCT02338193 (16) [back to overview]	Waist- to -Hip Ratio (WHR; Measure of Central Adiposity)
NCT02338193 (16) [back to overview]	Waist-to-height Ratio (WHtR)
NCT02338193 (16) [back to overview]	Body Mass Index (BMI)
NCT02338193 (16) [back to overview]	Change in Body Weight
NCT02338193 (16) [back to overview]	Change in Percent Body Weight
NCT02338193 (16) [back to overview]	Diastolic Blood Pressure (DBP)
NCT02338193 (16) [back to overview]	Fasting Blood Glucose (FBG)
NCT02338193 (16) [back to overview]	Fasting Insulin Sensitivity (HOMA-IR)
NCT02338193 (16) [back to overview]	First Phase Insulin Secretion (IGI/HOMA-IR)
NCT02338193 (16) [back to overview]	Liver Enzymes
NCT02338193 (16) [back to overview]	Matsuda Sensitivity Index (SI OGTT)
NCT02338193 (16) [back to overview]	Mean Blood Glucose (MBG) During an OGTT
NCT02338193 (16) [back to overview]	Systolic Blood Pressure (SBP)
NCT02338193 (16) [back to overview]	Total Cholesterol Levels (CHOL)
NCT02338193 (16) [back to overview]	Triglyceride (TRG) Levels
NCT02371187 (5) [back to overview]	Change From Baseline of Insulin Sensitivity at Week 12
NCT02371187 (5) [back to overview]	Change From Baseline of Fat Free Mass at Week 12
NCT02371187 (5) [back to overview]	Change From Baseline of Respiratory Exchange Ratio at Week 12
NCT02371187 (5) [back to overview]	Change From Baseline of Maximal Oxygen Uptake at Week 12
NCT02371187 (5) [back to overview]	Change From Baseline of Maximal Aerobic Enzyme Activities in Skeletal Muscle at Week 12
NCT02413398 (4) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.
NCT02413398 (4) [back to overview]	Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.
NCT02413398 (4) [back to overview]	Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.
NCT02413398 (4) [back to overview]	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
NCT02419612 (8) [back to overview]	Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.
NCT02419612 (8) [back to overview]	Change From Baseline in Total Body Weight at Week 52
NCT02419612 (8) [back to overview]	Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52
NCT02419612 (8) [back to overview]	Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
NCT02419612 (8) [back to overview]	Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.
NCT02419612 (8) [back to overview]	Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period
NCT02419612 (8) [back to overview]	Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52
NCT02419612 (8) [back to overview]	Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156
NCT02426541 (3) [back to overview]	Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake
NCT02426541 (3) [back to overview]	Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8
NCT02426541 (3) [back to overview]	Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake
NCT02429258 (11) [back to overview]	Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4
NCT02429258 (11) [back to overview]	Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
NCT02429258 (11) [back to overview]	Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4
NCT02429258 (11) [back to overview]	Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4
NCT02429258 (11) [back to overview]	Change in Fructosamine From Baseline to Week 4
NCT02429258 (11) [back to overview]	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4
NCT02429258 (11) [back to overview]	Change in HbA1c From Baseline to Week 4
NCT02429258 (11) [back to overview]	Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population
NCT02429258 (11) [back to overview]	Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population
NCT02429258 (11) [back to overview]	Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population
NCT02429258 (11) [back to overview]	Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population
NCT02433678 (14) [back to overview]	Changes in Expression of Inflammatory Mediators
NCT02433678 (14) [back to overview]	Change in Hypertension Mediators
NCT02433678 (14) [back to overview]	Change in Hypertension Mediators
NCT02433678 (14) [back to overview]	Change in Hypertension Mediators
NCT02433678 (14) [back to overview]	Change in Hypertension Mediators
NCT02433678 (14) [back to overview]	Difference in the Percent Change in Fasting Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Activation (DNA Binding Activity) in Mononuclear Cells Before and After Dapagliflozin Use
NCT02433678 (14) [back to overview]	Changes in Expression of Inflammatory Mediators
NCT02433678 (14) [back to overview]	Changes in Expression of Inflammatory Mediators
NCT02433678 (14) [back to overview]	Change in Hypertension Mediators
NCT02433678 (14) [back to overview]	Changes in Expression of Inflammatory Mediators
NCT02433678 (14) [back to overview]	Changes in Expression of Inflammatory Mediators
NCT02433678 (14) [back to overview]	Changes in Expression of Inflammatory Mediators
NCT02433678 (14) [back to overview]	Change in Hypertension Mediators
NCT02433678 (14) [back to overview]	Change in Hypertension Mediators
NCT02460978 (6) [back to overview]	Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24
NCT02460978 (6) [back to overview]	Change From Baseline in the Percent of 24-hour Glucose Readings Obtained From CGM That Falls Within the Target Range of > 70 mg/dL and <= 180 mg/dL (%) at Week 24
NCT02460978 (6) [back to overview]	Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24
NCT02460978 (6) [back to overview]	Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24
NCT02460978 (6) [back to overview]	Adjusted Mean Change From Baseline in HbA1c at Week 24
NCT02460978 (6) [back to overview]	Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24
NCT02471404 (6) [back to overview]	Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
NCT02471404 (6) [back to overview]	Time to Rescue
NCT02471404 (6) [back to overview]	Patients With at Least One Episode of Confirmed Hypoglycaemia
NCT02471404 (6) [back to overview]	Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52
NCT02471404 (6) [back to overview]	Number of Patients Rescued
NCT02471404 (6) [back to overview]	Change in Total Body Weight From Baseline at Week 52
NCT02475070 (2) [back to overview]	Incretin Hormones
NCT02475070 (2) [back to overview]	Glucagon Response to Meal
NCT02520518 (3) [back to overview]	Change From Baseline in Perception of Satiety at Week 12
NCT02520518 (3) [back to overview]	Change From Baseline in Perception of Hunger at Week 12
NCT02520518 (3) [back to overview]	Change From Baseline in Blood Pressure at Week 12
NCT02532855 (10) [back to overview]	Change From Baseline in A1C at Week 24
NCT02532855 (10) [back to overview]	Change From Baseline in 2-hr Postprandial Glucose (PPG) at Week 24
NCT02532855 (10) [back to overview]	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
NCT02532855 (10) [back to overview]	Change From Baseline in Glucagon Area Under the Curve (AUC0-120 Minutes) at Week 24
NCT02532855 (10) [back to overview]	Percentage of Participants Who Experienced One or More Adverse Events
NCT02532855 (10) [back to overview]	Change From Baseline in Incremental 2-hour (2-hr) Postprandial Glucose Excursion (PPGE) at Week 24
NCT02532855 (10) [back to overview]	Change From Baseline in Insulin AUC0-120 Minutes at Week 24
NCT02532855 (10) [back to overview]	Change From Baseline in Postprandial Insulin AUC0-120 Minutes to Glucagon AUC0-120 Minutes Ratio at Week 24
NCT02532855 (10) [back to overview]	Percentage of Participants Who Discontinued Study Drug Due to an AE
NCT02532855 (10) [back to overview]	Percentage of Participants With A1C <7% (53 mmol/Mol) at Week 24
NCT02547935 (8) [back to overview]	Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24
NCT02547935 (8) [back to overview]	Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
NCT02547935 (8) [back to overview]	Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24
NCT02547935 (8) [back to overview]	Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24
NCT02547935 (8) [back to overview]	Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24
NCT02547935 (8) [back to overview]	Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24
NCT02547935 (8) [back to overview]	Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24
NCT02547935 (8) [back to overview]	Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24
NCT02551874 (6) [back to overview]	Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24
NCT02551874 (6) [back to overview]	Percentage of Subjects With Confirmed Hypoglycaemia at Week 24
NCT02551874 (6) [back to overview]	Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24
NCT02551874 (6) [back to overview]	Change From Baseline in the Mean Value of 24-hour Glucose at Week 2
NCT02551874 (6) [back to overview]	Mean Change From Baseline in HbA1c at Week 24
NCT02551874 (6) [back to overview]	Mean Change From Baseline in Total Body Weight at Week 24
NCT02561130 (9) [back to overview]	Glycated Hemoglobin (HbA1C)
NCT02561130 (9) [back to overview]	Number of Participants Achieving Diabetes Relapse Without Overt Hyperglycemia Off Diabetes Drugs
NCT02561130 (9) [back to overview]	Number of Participants Achieving Drug-free Diabetes Remission in the Experimental Group Compared to the Control Group
NCT02561130 (9) [back to overview]	Number of Participants With Non-severe Symptomatic Hypoglycemic Episodes
NCT02561130 (9) [back to overview]	Number of Participants With Severe Hypoglycemic Episodes
NCT02561130 (9) [back to overview]	Percentage of Weight Loss From Baseline
NCT02561130 (9) [back to overview]	Number of Participants Achieving Drug-free HbA1C < 6.0%
NCT02561130 (9) [back to overview]	Change in Waist Circumference From Baseline
NCT02561130 (9) [back to overview]	Number of Participants Achieving Drug-free Diabetes Remission
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Body Mass Index (BMI) at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Adinopectin at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan
NCT02564926 (15) [back to overview]	Adjusted Mean Change in HbA1c at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Waist Circumference at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Total Body Weight at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52
NCT02564926 (15) [back to overview]	Adjusted Mean Change in Lean Body Mass at Week 52
NCT02582814 (17) [back to overview]	Adjusted Percent Change From Baseline in Body Weight
NCT02582814 (17) [back to overview]	Adjusted Change From Baseline in Post-prandial Glucose Measured by 6-point SMBG
NCT02582814 (17) [back to overview]	Adjusted Change From Baseline in HbA1c
NCT02582814 (17) [back to overview]	Adjusted Change From Baseline in Glycoalbumin
NCT02582814 (17) [back to overview]	Adjusted Change From Baseline in Average Daily Glucose Measured by 6-point SMBG
NCT02582814 (17) [back to overview]	Vital Signs (Heart Rate)
NCT02582814 (17) [back to overview]	Overall Adverse Event Summary
NCT02582814 (17) [back to overview]	Adjusted Change From Baseline in SBP in Subjects With Baseline SBP/DBP >= 140/90 mmHg
NCT02582814 (17) [back to overview]	Proportion of Subjects Achieving HbA1c Reduction of 0.5 Percent
NCT02582814 (17) [back to overview]	Hypoglycemia
NCT02582814 (17) [back to overview]	Clinical Laboratory Measures, Urine Test Results (Any Marked Abnormality)
NCT02582814 (17) [back to overview]	ECGs
NCT02582814 (17) [back to overview]	Diabetic Ketoacidosis (DKA)
NCT02582814 (17) [back to overview]	Vital Signs (Blood Pressure)
NCT02582814 (17) [back to overview]	Adjusted Percent Change From Baseline in Total Daily Insulin Dose
NCT02582814 (17) [back to overview]	Proportion of Subjects Achieving HbA1c < 7.0 Percent
NCT02582814 (17) [back to overview]	Proportion of Subjects Achieving HbA1c Reduction of 0.5 Percent Without Severe Hypoglycemia
NCT02582840 (15) [back to overview]	Daily Basal Insulin (IU) Percent Change From Baseline to Day 7 - Pharmacodynamic (PD) Set
NCT02582840 (15) [back to overview]	Daily Bolus Insulin (IU) Percent Change From Baseline to Day 7 - Pharmacodynamic (PD) Set
NCT02582840 (15) [back to overview]	Dapagliflozin 3-O-Glucuronide Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set
NCT02582840 (15) [back to overview]	Dapagliflozin 3-O-Glucuronide Maximum Observed Plasma Concentration (Cmax) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set
NCT02582840 (15) [back to overview]	Dapagliflozin 3-O-Glucuronide Minimum Observed Plasma Concentration (Cmin) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set
NCT02582840 (15) [back to overview]	Dapagliflozin Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set
NCT02582840 (15) [back to overview]	Dapagliflozin Maximum Observed Plasma Concentration (Cmax) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set
NCT02582840 (15) [back to overview]	Dapagliflozin Minimum Observed Plasma Concentration (Cmin) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set
NCT02582840 (15) [back to overview]	Dapagliflozin Ratio of Metabolite to Parent AUC of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set
NCT02582840 (15) [back to overview]	Dapagliflozin Time of Maximum Observed Plasma Concentration (Tmax) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set
NCT02582840 (15) [back to overview]	Fasting Plasma Glucose (FPG) (mg/dL) Change From Baseline to Day 7 - Pharmacodynamic (PD) Set
NCT02582840 (15) [back to overview]	Seated Systolic Blood Pressure (mmHG) Change From Baseline to Day 7 - Pharmacodynamic (PD) Set
NCT02582840 (15) [back to overview]	Total Daily Insulin (IU) Percent Change From Baseline to Day 7 - Pharmacodynamic (PD) Set
NCT02582840 (15) [back to overview]	Dapagliflozin 3-O-Glucuronide Time of Maximum Observed Plasma Concentration (Tmax) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set
NCT02582840 (15) [back to overview]	24-hour Urinary Glucose (g/24h) Mean Change From Baseline on Day 7 - Pharmacodynamic (PD) Set
NCT02592421 (4) [back to overview]	Change in Plasma Insulin During Measurement of EGP
NCT02592421 (4) [back to overview]	Change in Plasma Glucose Concentration
NCT02592421 (4) [back to overview]	Change in Glucagon During EGP Measurement
NCT02592421 (4) [back to overview]	Change in Endogenous Glucose Production (EGP)
NCT02597049 (11) [back to overview]	Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks
NCT02597049 (11) [back to overview]	Rate of Hypoglycemic Events Adjusted Per 30 Days
NCT02597049 (11) [back to overview]	Percentage of Participants With HbA1c <7%
NCT02597049 (11) [back to overview]	Number of Participants With Adjudicated Cardiovascular (CV) Events
NCT02597049 (11) [back to overview]	Change From Baseline in Fasting Glucagon at 24 Weeks
NCT02597049 (11) [back to overview]	Change From Baseline in Body Weight at 24 Weeks
NCT02597049 (11) [back to overview]	Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks
NCT02597049 (11) [back to overview]	Number of Participants With Adjudicated Acute Pancreatitis Events
NCT02597049 (11) [back to overview]	Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia
NCT02597049 (11) [back to overview]	Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)
NCT02597049 (11) [back to overview]	Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)
NCT02613897 (9) [back to overview]	Change in Lipid Oxidation
NCT02613897 (9) [back to overview]	HBA1c
NCT02613897 (9) [back to overview]	Mean Oral Glucose Tolerance Test (OGTT)
NCT02613897 (9) [back to overview]	Change in BMI
NCT02613897 (9) [back to overview]	Change in Free Fatty Acids (FFA)
NCT02613897 (9) [back to overview]	Change in Body Weight
NCT02613897 (9) [back to overview]	Change in Fasting Plasma Glucagon (FPG)
NCT02613897 (9) [back to overview]	Change in Endogenous Glucose Production (EGP)
NCT02613897 (9) [back to overview]	Change in Glucose Oxidation
NCT02635386 (23) [back to overview]	Matsuda Sensitivity Index Derived From the OGTT(SI OGTT)
NCT02635386 (23) [back to overview]	OGTT Mean Blood Glucose (MBG)
NCT02635386 (23) [back to overview]	Oral Disposition (Insulin Sensitivity-insulin Secretion) Index
NCT02635386 (23) [back to overview]	Total Body Fat (%) by DEXA
NCT02635386 (23) [back to overview]	Total Cholesterol Levels
NCT02635386 (23) [back to overview]	Total Fat Mass (kg) Evaluated by DEXA
NCT02635386 (23) [back to overview]	Total Testosterone Concentrations
NCT02635386 (23) [back to overview]	Triglyceride (TRG) Levels
NCT02635386 (23) [back to overview]	Trunk/Leg Fat Ratio by DEXA
NCT02635386 (23) [back to overview]	Waist-to-Height Ratio (WHtR)
NCT02635386 (23) [back to overview]	Waist-to-Hip Ratio (WHR)
NCT02635386 (23) [back to overview]	Corrected First Phase Insulin Secretion (IGI/HOMA-IR)
NCT02635386 (23) [back to overview]	Dehydroepiandrosterone Sulfate (DHEA-S) Levels
NCT02635386 (23) [back to overview]	Diastolic Blood Pressure (DBP)
NCT02635386 (23) [back to overview]	Fasting Blood Glucose
NCT02635386 (23) [back to overview]	Fasting Insulin Sensitivity (HOMA-IR)
NCT02635386 (23) [back to overview]	Free Androgen Index (FAI)
NCT02635386 (23) [back to overview]	Change in Percent Body Weight
NCT02635386 (23) [back to overview]	Central Adiposity (Waist Circumference)
NCT02635386 (23) [back to overview]	Body Mass Index (BMI)
NCT02635386 (23) [back to overview]	Android-Gynoid Ratio (AGR) as Determined by DEXA
NCT02635386 (23) [back to overview]	Absolute Body Weight
NCT02635386 (23) [back to overview]	Systolic Blood Pressure (SBP)
NCT02637037 (7) [back to overview]	Time to Reach Maximum Plasma Concentration (t Max)
NCT02637037 (7) [back to overview]	Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration [Vz/F]
NCT02637037 (7) [back to overview]	Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC [CL/F]
NCT02637037 (7) [back to overview]	Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State
NCT02637037 (7) [back to overview]	AUC From Time Zero to Time of Last Quantifiable Concentration [AUC (0-t)] Under Fasted or Fed State.
NCT02637037 (7) [back to overview]	Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve [t½λz]
NCT02637037 (7) [back to overview]	Observed Maximum Plasma Concentration [Cmax] Under Fasted or Fed State
NCT02653482 (11) [back to overview]	Difference in the Average of the 6- and 12-week Mean N-terminal Pro B-type Natriuretic Peptide (NTproBNP).
NCT02653482 (11) [back to overview]	Percentage of Patients That Achieve a ≥ 5-point Increase in Heart Failure Disease Specific Quality of Life (Assessed Using Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)) or a ≥ 20% Decrease in NTproBNP Over 12 Weeks
NCT02653482 (11) [back to overview]	Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OS) and a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
NCT02653482 (11) [back to overview]	Change in 6 Minute Walk Score Over 12 Weeks.
NCT02653482 (11) [back to overview]	Change in Brain Natriuretic Peptide (BNP) Over 12 Weeks.
NCT02653482 (11) [back to overview]	Change in Hemoglobin A1c (HbA1c) Over 12 Weeks.
NCT02653482 (11) [back to overview]	Change in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) Over 12 Weeks.
NCT02653482 (11) [back to overview]	Percentage of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
NCT02653482 (11) [back to overview]	Change in Weight Over 12 Weeks
NCT02653482 (11) [back to overview]	Change in Systolic Blood Pressure Over 12 Weeks
NCT02653482 (11) [back to overview]	Percentage of Patients With a ≥ 5-point Increase in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)
NCT02681094 (4) [back to overview]	Change in Total Body Weight at 24 Weeks
NCT02681094 (4) [back to overview]	Change in Fasting Plasma Glucose at 24 Weeks
NCT02681094 (4) [back to overview]	Change From Baseline in HbA1c at Week 24
NCT02681094 (4) [back to overview]	Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks
NCT02682563 (10) [back to overview]	Fractional Excretion of Glucose in % of Filtered Glucose
NCT02682563 (10) [back to overview]	Body Weight
NCT02682563 (10) [back to overview]	Effective Renal Plasma Flow (ERPF) in ml/Min
NCT02682563 (10) [back to overview]	Fractional Excretion of Potassium in % of Filtered Potassium
NCT02682563 (10) [back to overview]	Fractional Excretion of Sodium in % of Filtered Sodium
NCT02682563 (10) [back to overview]	Glomerular Filtration Rate (GFR) in ml/Min
NCT02682563 (10) [back to overview]	Kidney Injury Molecule-1 (KIM-1) in ng/mmol
NCT02682563 (10) [back to overview]	Neutrophil Gelatinase-associated Lipocalin (NGAL)
NCT02682563 (10) [back to overview]	Systolic Blood Pressure
NCT02682563 (10) [back to overview]	Urinary Albumin-Creatinine Ratio in mg/mmol
NCT02700334 (17) [back to overview]	Insulin Sensitivity
NCT02700334 (17) [back to overview]	Postprandial Glucose
NCT02700334 (17) [back to overview]	Systolic Blood Pressure
NCT02700334 (17) [back to overview]	Total Cholesterol
NCT02700334 (17) [back to overview]	Total Insulin Secretion
NCT02700334 (17) [back to overview]	Uric Acid
NCT02700334 (17) [back to overview]	First Phase of Insulin Secretion
NCT02700334 (17) [back to overview]	Fasting Glucose
NCT02700334 (17) [back to overview]	Diastolic Blood Pressure
NCT02700334 (17) [back to overview]	Creatinine
NCT02700334 (17) [back to overview]	Body Weight
NCT02700334 (17) [back to overview]	Body Mass Index
NCT02700334 (17) [back to overview]	Aspartate Aminotransferase (AST)
NCT02700334 (17) [back to overview]	Alanine Aminotransferase (ALT)
NCT02700334 (17) [back to overview]	Triglycerides
NCT02700334 (17) [back to overview]	Glycosylated Hemoglobin
NCT02700334 (17) [back to overview]	High Density Lipoprotein Cholesterol (HDL-c)
NCT02722239 (5) [back to overview]	Maximum Concentration (Cmax).
NCT02722239 (5) [back to overview]	Bioequivalence Consideration: 90% Confidence Intervals for the Test:Reference Geometric Least Squares Mean Ratios
NCT02722239 (5) [back to overview]	"Area Under the Concentration - Time Curve (AUC0-t)"
NCT02722239 (5) [back to overview]	"Area Under the Concentration - Time Curve (AUC0-∞)"
NCT02722239 (5) [back to overview]	Adverse Events
NCT02725593 (4) [back to overview]	Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24
NCT02725593 (4) [back to overview]	Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24
NCT02725593 (4) [back to overview]	Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control
NCT02725593 (4) [back to overview]	Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
NCT02796170 (2) [back to overview]	Change in Blood Pressure From Baseline to 6 Weeks Measured by ABPM
NCT02796170 (2) [back to overview]	Change in Urinary AGT Levels From Baseline to 6 Weeks
NCT02911792 (1) [back to overview]	GFR (Glomerular Filtration Rate) Change After Treatment
NCT02973477 (4) [back to overview]	Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.
NCT02973477 (4) [back to overview]	Changes in Measures of Cardiac Autonomic Reflex Testing (CARTs)
NCT02973477 (4) [back to overview]	Changes in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.
NCT02973477 (4) [back to overview]	Change in B-type Natriuretic Peptide With Each Intervention as a Measure of Left Ventricular Function
NCT02981069 (5) [back to overview]	Change in Endogenous Glucose Production (EGP) After 16 Weeks of Treatment With Each Study Drug.
NCT02981069 (5) [back to overview]	Change in Endogenous Glucose Production (EGP) After Acute Exposure to a Single Dose and Again After 16 Weeks of Treatment
NCT02981069 (5) [back to overview]	Change in Fasting Plasma Glucose (FPG) Concentration
NCT02981069 (5) [back to overview]	Change in Plasma Glucagon Concentration
NCT02981069 (5) [back to overview]	Change in Plasma Insulin Concentration
NCT02981966 (2) [back to overview]	Renal Glucose Production Measurement of Change
NCT02981966 (2) [back to overview]	Endogenous Glucose Production Measurement
NCT02984644 (12) [back to overview]	Change in Plasma Insulin Concentrations: Study 1
NCT02984644 (12) [back to overview]	Change in Plasma Glucose Using a Pancreatic Clamp: Study 3
NCT02984644 (12) [back to overview]	Change in Plasma Glucose Measurement Using a Glucose Clamp: Study 2
NCT02984644 (12) [back to overview]	Change in Glucagon: Study 1
NCT02984644 (12) [back to overview]	Change in Glucagon Using Pancreatic Clamp: Study 3
NCT02984644 (12) [back to overview]	Change in EGP: Study 1
NCT02984644 (12) [back to overview]	Change in EGP With Pancreatic Clamp: Study 3
NCT02984644 (12) [back to overview]	Change in EGP With Glucose Clamp: Study 2
NCT02984644 (12) [back to overview]	Change in Glucagon Using Glucose Clamp: Study 2
NCT02984644 (12) [back to overview]	Plasma Insulin Concentrations During Measurement of EGP Plus Glucose Clamp: Study 2
NCT02984644 (12) [back to overview]	Measurement of the Change in Plasma Glucose (mg/dL): Study 1
NCT02984644 (12) [back to overview]	Change in Plasma Insulin While Using Pancreatic Clamp: Study 3
NCT03006471 (33) [back to overview]	24-hours Systolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Coefficient of Variation of 24-hours, Diastolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Number of Participants With a Dipper Reverse Circadian Blood Pattern at Week 12
NCT03006471 (33) [back to overview]	Number of Participants With a Nondipper Circadian Blood Pressure Pattern at Week 12
NCT03006471 (33) [back to overview]	Number of Participants With Prediabetes at Week 12
NCT03006471 (33) [back to overview]	Number of Participants With Prediabetes Plus Prehypertension at Week 12
NCT03006471 (33) [back to overview]	24-hours Diastolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Coefficient of Variation Nighttime, Systolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Average Real Variability of Diastolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Average Real Variability of Systolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Body Mass Index at Week 12
NCT03006471 (33) [back to overview]	Fasting Plasma Glucose Levels at Week 12
NCT03006471 (33) [back to overview]	Body Weight at Week 12
NCT03006471 (33) [back to overview]	Coefficient of Variation Daytime, Diastolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Number of Participants With Prehypertension at Week 12
NCT03006471 (33) [back to overview]	Coefficient of Variation Daytime, Systolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Office of Diastolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Office Systolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Systolic Blood Pressure Weighted Standard Deviation at Week 12
NCT03006471 (33) [back to overview]	Glycated Hemoglobin A1c (A1C) at Week 12
NCT03006471 (33) [back to overview]	Nighttime Diastolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Coefficient of Variation Nighttime, Diastolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Nighttime Systolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Nighttime Mean Arterial Pressure at Week 12
NCT03006471 (33) [back to overview]	Nocturnal Hypertensive Load at Week 12
NCT03006471 (33) [back to overview]	Number of Participants With a Dipper Circadian Blood Pressure Pattern at Week 12
NCT03006471 (33) [back to overview]	2-hours Plasma Glucose After a Oral Glucose Tolerance Test at Week 12
NCT03006471 (33) [back to overview]	Coefficient of Variation of 24-hours, Systolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Daytime Diastolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Daytime Hypertensive Load at Week 12
NCT03006471 (33) [back to overview]	Daytime Mean Arterial Pressure at Week 12
NCT03006471 (33) [back to overview]	Daytime Systolic Blood Pressure at Week 12
NCT03006471 (33) [back to overview]	Diastolic Blood Pressure Weighted Standard Deviation at Week 12
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on Proportion of Patients With ≥ 5 Point Increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) and ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide(NTproBNP)
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on Hemoglobin A1c
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on Brain Natriuretic Peptide (BNP)
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on Weight
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 5 Point Increase in KCCQ Clinical Summary Score (KCCQ-CS) and KCCQ Overall Summary Score (KCCQ-OS)
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on the Proportion of Patients With a ≥ 20% Decrease in N-terminal Pro B-type Natriuretic Peptide (NTproBNP)
NCT03030235 (11) [back to overview]	Effect of Dapagliflozin, as Compared With Placebo, on Systolic Blood Pressure
NCT03036124 (6) [back to overview]	Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
NCT03036124 (6) [back to overview]	Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.
NCT03036124 (6) [back to overview]	Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.
NCT03036124 (6) [back to overview]	Change From Baseline in the KCCQ Total Symptom Score
NCT03036124 (6) [back to overview]	Subjects Included in the Endpoint of All-cause Mortality.
NCT03036124 (6) [back to overview]	Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
NCT03036150 (4) [back to overview]	Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.
NCT03036150 (4) [back to overview]	Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.
NCT03036150 (4) [back to overview]	Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.
NCT03036150 (4) [back to overview]	Time to Death From Any Cause.
NCT03074630 (7) [back to overview]	Change in Peripheral Insulin Sensitivity
NCT03074630 (7) [back to overview]	Change in Plasma HDL Cholesterol
NCT03074630 (7) [back to overview]	Change in Plasma LDL Cholesterol
NCT03074630 (7) [back to overview]	Change in Plasma Triglycerides
NCT03074630 (7) [back to overview]	Change in Total Cholesterol
NCT03074630 (7) [back to overview]	Urinary Glucose Excretion
NCT03074630 (7) [back to overview]	Change in Plasma FFA
NCT03152084 (17) [back to overview]	Change in Extracellular Volume From End of Treatment to End of Follow-up
NCT03152084 (17) [back to overview]	Change in 24-hour Sodium Excretion From Baseline to Start of Treatment
NCT03152084 (17) [back to overview]	Change in 24-hour Glucose Excretion From Baseline to Start of Treatment
NCT03152084 (17) [back to overview]	Pharmacokinetics of Dapagliflozin on Day 4 and Day 14
NCT03152084 (17) [back to overview]	Number of Patients With AEs and SAEs
NCT03152084 (17) [back to overview]	Change in 24-hour Urine Albumin:Creatinine Ratio (UACR)
NCT03152084 (17) [back to overview]	Change in 24-hour Sodium Excretion From Baseline to End of Treatment and From End of Treatment to Follow-up
NCT03152084 (17) [back to overview]	Change in Plasma Volume From End of Treatment to End of Follow-up
NCT03152084 (17) [back to overview]	Change in Plasma Volume From Baseline to Start of Treatment
NCT03152084 (17) [back to overview]	Change in Plasma Volume From Baseline to End of Treatment
NCT03152084 (17) [back to overview]	Change in 24-hour Glucose Excretion From Baseline to End of Treatment
NCT03152084 (17) [back to overview]	Change in 24-hour Glucose Excretion From End of Treatment to Follow-up
NCT03152084 (17) [back to overview]	Change in Mean 24-hour Systolic Blood Pressure From End of Treatment to End of Follow-up
NCT03152084 (17) [back to overview]	Change in Mean 24-hour Systolic Blood Pressure From Baseline to Start of Treatment
NCT03152084 (17) [back to overview]	Change in Mean 24-hour Systolic Blood Pressure From Baseline to End of Treatment
NCT03152084 (17) [back to overview]	Change in Extracellular Volume From Baseline to Start of Treatment
NCT03152084 (17) [back to overview]	Change in Extracellular Volume From Baseline to End of Treatment
NCT03168295 (6) [back to overview]	Change in Endogenous Glucose Production (EGP)
NCT03168295 (6) [back to overview]	Change in Endogenous Glucose Production (EGP)
NCT03168295 (6) [back to overview]	Change in Fasting Plasma Glucose
NCT03168295 (6) [back to overview]	Change in Fasting Plasma Glucose
NCT03168295 (6) [back to overview]	Change in Fasting Plasma Insulin
NCT03168295 (6) [back to overview]	Change in Fasting Plasma Insulin
NCT03180489 (4) [back to overview]	Change From Baseline in Perception of Satiety at Week 12
NCT03180489 (4) [back to overview]	Change From Baseline in Perception of Hunger at Week 12
NCT03180489 (4) [back to overview]	Change From Baseline in Insulin Sensitivity at Week 12 Via Oral Glucose Tolerance Test
NCT03180489 (4) [back to overview]	Change From Baseline in Blood Pressure at Week 12
NCT03316131 (7) [back to overview]	Change From Baseline in Urinary Excretion of Serum UA (sUA) on Day 7
NCT03316131 (7) [back to overview]	Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7
NCT03316131 (7) [back to overview]	Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7
NCT03316131 (7) [back to overview]	Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7
NCT03316131 (7) [back to overview]	Change From Baseline in Plasma Concentration (Cmax) on Day 7
NCT03316131 (7) [back to overview]	Change From Baseline in Time of Last Measurable Concentration (Tlast) on Day 7
NCT03316131 (7) [back to overview]	Change From Baseline in Time to Reach Maximum Observed Concentration (Tmax) on Day 7
NCT03331289 (1) [back to overview]	Change in EGP From Baseline to Post-oral Glucose Load.
NCT03338855 (8) [back to overview]	Body Composition (Fat Mass and Lean Mass) After 5 Weeks of Treatment
NCT03338855 (8) [back to overview]	24-Hour Energy Expenditure After 5 Weeks of Treatment
NCT03338855 (8) [back to overview]	24-Hour RER After 5 Weeks of Treatment
NCT03338855 (8) [back to overview]	Body Composition (Total Mass) After 5 Weeks of Treatment
NCT03338855 (8) [back to overview]	Change in Respiratory Exchange Ratio (RER) From Fasted State to Insulin Stimulated State After 5 Weeks of Treatment
NCT03338855 (8) [back to overview]	Corrected Glucose Disposal Rate (cGDR) Measured as Change in Rate of Disposal (Delta RD) Basal vs High Insulin After 5 Weeks of Treatment
NCT03338855 (8) [back to overview]	Fibroblast Growth Factor 21 (FGF21) Area Under the Curve (AUC) in Plasma After 5 Weeks of Treatment
NCT03338855 (8) [back to overview]	Change in Endogenous Glucose Production (EGP) After 5 Weeks of Treatment
NCT03387683 (2) [back to overview]	Adjusted Mean Change From Baseline in Global Longitudinal Strain of the Left Ventricle (GLSLV) at End of Treatment.
NCT03387683 (2) [back to overview]	Adjusted Mean Change From Baseline in Myocardial Efficiency at End of Treatment.
NCT03619213 (7) [back to overview]	Subjects Included in the Endpoint of All-cause Mortality
NCT03619213 (7) [back to overview]	Change From Baseline in the KCCQ Total Symptom Score at 8 Months
NCT03619213 (7) [back to overview]	Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
NCT03619213 (7) [back to overview]	Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation
NCT03619213 (7) [back to overview]	Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation
NCT03619213 (7) [back to overview]	Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit)
NCT03619213 (7) [back to overview]	Subjects Included in the Endpoint of Cardiovascular Death
NCT03660683 (14) [back to overview]	Arterial Stiffness - Augmentation Index
NCT03660683 (14) [back to overview]	Serum Insulin Level
NCT03660683 (14) [back to overview]	Serum Glucose
NCT03660683 (14) [back to overview]	Serum Glucose
NCT03660683 (14) [back to overview]	Renal Function
NCT03660683 (14) [back to overview]	CD 34+ Cell Migratory Function
NCT03660683 (14) [back to overview]	CD 34+ Cell Fraction
NCT03660683 (14) [back to overview]	Blood Biochemistries
NCT03660683 (14) [back to overview]	Arterial Stiffness - Augmentation Pressure
NCT03660683 (14) [back to overview]	Arterial Stiffness
NCT03660683 (14) [back to overview]	Urine Exosome Assay
NCT03660683 (14) [back to overview]	Appetite Controlling Hormone
NCT03660683 (14) [back to overview]	Fasting Lipid Profile
NCT03660683 (14) [back to overview]	CD 34+ Cell Gene Expression
NCT03782259 (6) [back to overview]	Extracellular Volume Fraction (ECV)
NCT03782259 (6) [back to overview]	hsCRP
NCT03782259 (6) [back to overview]	Fasting Glucose
NCT03782259 (6) [back to overview]	HbA1C
NCT03782259 (6) [back to overview]	Global Myocardial Strain
NCT03782259 (6) [back to overview]	T2 Relaxation Time
NCT03877224 (4) [back to overview]	Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 16 (Higher Scores Represent Less HF Symptom Frequency and Burden)
NCT03877224 (4) [back to overview]	Change From Baseline in 6-minute Walk Distance (6MWD) at Week 16 (Larger Distances Represent Better Functional Capacity)
NCT03877224 (4) [back to overview]	Change From Baseline at the End of the Study in the Total Time Spent in Light to Vigorous Physical Activity, as Assessed Using a Wearable Activity Monitor (Accelerometer).
NCT03877224 (4) [back to overview]	Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Physical Limitation Score (KCCQ-PLS) at Week 16 (Higher Scores Represent Less Physical Limitation Due to HF)
NCT03877237 (4) [back to overview]	Change From Baseline in 6-minute Walk Distance (6MWD) at Week 16 (Larger Distances Represent Better Functional Capacity).
NCT03877237 (4) [back to overview]	Change From Baseline at the End of the Study in the Total Time Spent in Light to Vigorous Physical Activity, as Assessed Using a Wearable Activity Monitor (Accelerometer).
NCT03877237 (4) [back to overview]	Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 16 (Higher Scores Represent Less HF Symptom Frequency and Burden).
NCT03877237 (4) [back to overview]	Change From Baseline in Kansas-City Cardiomyopathy Questionnaire-Physical Limitation Score (KCCQ-PLS) at Week 16 (Higher Scores Represent Less Physical Limitation Due to HF)
NCT04249778 (14) [back to overview]	Number of Participants With Non-fatal Myocardial Infarction (MI)
NCT04249778 (14) [back to overview]	Number of Participants With Acute Kidney Injury
NCT04249778 (14) [back to overview]	Number of Participants Dying From Cardiovascular Reasons
NCT04249778 (14) [back to overview]	Serum Magnesium
NCT04249778 (14) [back to overview]	Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits for Heart Failure (HF) and Death After Admission With Acute Decompensated Heart Failure (ADHF)
NCT04249778 (14) [back to overview]	Weight
NCT04249778 (14) [back to overview]	Systolic Blood Pressure
NCT04249778 (14) [back to overview]	N-terminal (NT)-Pro Hormone BNP (NT-proBNP) Levels
NCT04249778 (14) [back to overview]	Left Atrial Volume Index (LAVI)
NCT04249778 (14) [back to overview]	Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
NCT04249778 (14) [back to overview]	Hemoglobin A1C (HbA1c) Level
NCT04249778 (14) [back to overview]	Chronic Heart Failure Questionnaire - Self-Administered Standardized Format (CHQ-SAS) Score
NCT04249778 (14) [back to overview]	6-Minute Walk Distance (6MWD)
NCT04249778 (14) [back to overview]	Number of Participants With Stroke
NCT04350593 (7) [back to overview]	Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30.
NCT04350593 (7) [back to overview]	Time to Death From Any Cause
NCT04350593 (7) [back to overview]	Time to Composite of Acute Kidney Injury or Initiation of Renal Replacement Therapy, or Death From Any Cause
NCT04350593 (7) [back to overview]	Time to Hospital Discharge
NCT04350593 (7) [back to overview]	Total Number of Days Alive, Not in the ICU, and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP)
NCT04350593 (7) [back to overview]	Prevention of COVID-19 Complications or Death: During the 30-day Treatment Period, Time to First Occurrence of New/Worsened Organ Dysfunction During Index Hospitalization or Death From Any Cause.
NCT04350593 (7) [back to overview]	Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP)
NCT04492722 (5) [back to overview]	Change From Baseline in Reduction of Urine ACR to Week 12
NCT04492722 (5) [back to overview]	Change From Baseline in 24-hours Mean Systolic Blood Pressure to Week 12
NCT04492722 (5) [back to overview]	Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20
NCT04492722 (5) [back to overview]	Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) to Week 12
NCT04492722 (5) [back to overview]	Number of Participants With Adverse Events and Serious Adverse Events
NCT04542291 (9) [back to overview]	Changes in Total Fat Volume in Visceral Fat Area as Assessed by CT-based Body Composition
NCT04542291 (9) [back to overview]	Changes in Ketones
NCT04542291 (9) [back to overview]	Tolerability as Measured by Number of Participants With Related Adverse Events
NCT04542291 (9) [back to overview]	Changes in Total Skeletal Muscle Volume in Visceral Fat Area as Assessed by CT-based Body Composition
NCT04542291 (9) [back to overview]	Changes in Total Muscle to Fat Ratio in Visceral Fat Area as Assessed by CT-based Body Composition
NCT04542291 (9) [back to overview]	Changes in HbA1c
NCT04542291 (9) [back to overview]	Changes in Plasma Glucose
NCT04542291 (9) [back to overview]	Changes in CA19-9
NCT04542291 (9) [back to overview]	Changes in CT-quantified Tumor Size
NCT04730947 (9) [back to overview]	Change in Body Weight
NCT04730947 (9) [back to overview]	Change in Total Blood Volume
NCT04730947 (9) [back to overview]	Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise
NCT04730947 (9) [back to overview]	Change in Right Atrial (RA) Pressure at Rest
NCT04730947 (9) [back to overview]	Change in Plasma Volume
NCT04730947 (9) [back to overview]	Change in Right Atrial (RA) Pressure at Maximal Exercise
NCT04730947 (9) [back to overview]	Change in Mean Pulmonary Arterial Pressure (PA) at Rest
NCT04730947 (9) [back to overview]	Pulmonary Capillary Wedge Pressure (PCWP) at Rest
NCT04730947 (9) [back to overview]	Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
NCT04899349 (5) [back to overview]	Overall Response Rate (ORR) With Confirmed Response Based on Local Investigator Assessment as Per RECIST 1.1.
NCT04899349 (5) [back to overview]	Clinical Benefit Rate (CBR) With Confirmed Response Based on Local Investigator Assessment as Per RECIST 1.1
NCT04899349 (5) [back to overview]	Progression-free Survival (PFS) Based on Local Investigator Assessment
NCT04899349 (5) [back to overview]	Number of Participants With Dose Modifications
NCT04899349 (5) [back to overview]	Number of Participants With Hyperglycemia Grade ≥ 3 Over the First Eight Weeks of Alpelisib Plus Fulvestrant Treatment

Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2

Therapeutic glycemic response is defined as HbA1c <=6.5%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT00357370)
Timeframe: From Baseline to Week 12

Intervention	Participants (Number)
Placebo	0
Dapagliflozin 10 mg	1
Dapagliflozin 20 mg	0

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2

Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 12 in the double-blind period. (NCT00357370)
Timeframe: From Baseline to Week 12

Intervention	mg/dL (Mean)
Placebo	17.80
Dapagliflozin 10 mg	2.36
Dapagliflozin 20 mg	-9.64

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, and 12 in the double-blind period. (NCT00357370)
Timeframe: From Baseline to Week 12

Intervention	% of hemoglobin (Mean)
Placebo	0.09
Dapagliflozin 10 mg	-0.61
Dapagliflozin 20 mg	-0.69

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Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2

Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects. TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period. (NCT00357370)
Timeframe: From Baseline to Week 12

Intervention	units/day (Mean)
Placebo	1.69
Dapagliflozin 10 mg	-1.35
Dapagliflozin 20 mg	-0.83

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Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2

Therapeutic glycemic response is defined as HbA1c <7.0%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT00357370)
Timeframe: From Baseline to Week 12

Intervention	Participants (Number)
Placebo	1
Dapagliflozin 10 mg	3
Dapagliflozin 20 mg	1

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Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2

Therapeutic glycemic response is defined as HbA1c decrease from baseline >= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT00357370)
Timeframe: From Baseline to Week 12

Intervention	Participants (Number)
Placebo	3
Dapagliflozin 10 mg	15
Dapagliflozin 20 mg	15

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Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)

Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as >=5.6 mg/dL for ages 17-65 years or >=5.1 mg/dL for ages >=66. (NCT00528372)
Timeframe: Baseline to Week 102 (end of Long-term Period)

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Intervention	Participants (Number)
	Hematocrit (>55%)	Hematocrit (>60%)	Hemoglobin (>18 g/dL)	Glucose ( >350 mg/dL)	Glucose (<54 mg/dL)	Creatine kinase (>5*ULN)	Creatine kinase (>10*ULN)	Calcium, total (<7.5 mg/dL)	Bicarbonate (<=13 mEq/L)	Potassium, serum (>=6 mEqL)	Sodium, serum (<130 mEq/L)	Sodium, serum (>150 mEq/L)	Phosphorus, inorganic (high)	Albumin/creatinine ratio (>1800 mg/g)	Creatinine (>=1.5 preRX creatinine)
Group 1: Dapagliflozin Placebo	0	0	0	2	0	1	0	3	0	3	1	1	2	0	0
Group 1: Dapagliflozin, 10 mg AM	2	1	4	0	0	1	1	0	0	2	0	0	0	0	1
Group 1: Dapagliflozin, 10 mg PM	4	1	6	0	0	2	1	1	0	1	1	0	2	0	1
Group 1: Dapagliflozin, 2.5 mg AM	1	0	3	2	0	0	0	0	0	1	2	1	0	1	1
Group 1: Dapagliflozin, 2.5 mg PM	2	0	2	0	2	1	1	3	0	4	0	1	0	0	1
Group 1: Dapagliflozin, 5 mg AM	0	0	2	0	0	0	0	0	1	1	0	0	1	0	2
Group 1: Dapagliflozin, 5 mg PM	1	0	1	0	0	1	1	2	0	1	0	0	3	0	1
Group 2: Dapagliflozin, 10 mg AM	4	1	5	0	0	0	0	0	0	1	1	0	2	0	1
Group 2: Dapagliflozin, 5 mg AM	2	0	3	0	0	0	0	0	0	1	0	0	0	0	1

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Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. (NCT00528372)
Timeframe: From Baseline to Week 24 (end of Short-term Period)

Intervention	Kilograms (Mean)
Group 2: Dapagliflozin, 5 mg AM	-2.06
Group 2: Dapagliflozin, 10 mg AM	-1.90

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Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)

Intervention	Percentage of participants (Number)
Group 1: Dapagliflozin Placebo AM & PM	31.6
Group 1: Dapagliflozin, 2.5 mg AM	41.3
Group 1: Dapagliflozin, 5 mg AM	44.2
Group 1: Dapagliflozin, 10 mg AM	50.8
Group 1: Dapagliflozin, 2.5 mg PM	51.4
Group 1: Dapagliflozin, 5 mg PM	44.0
Group 1: Dapagliflozin, 10 mg PM	51.6

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Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)

Intervention	Percentage of participants (Number)
Group 1: Dapagliflozin Placebo AM & PM	14.5
Group 1: Dapagliflozin, 2.5 mg AM	27.2
Group 1: Dapagliflozin, 5 mg AM	26.6
Group 1: Dapagliflozin, 10 mg AM	23.1
Group 1: Dapagliflozin, 2.5 mg PM	33.4
Group 1: Dapagliflozin, 5 mg PM	25.8
Group 1: Dapagliflozin, 10 mg PM	26.0

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Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days. (NCT00528372)
Timeframe: Day 1 to Week 102 (end of Long-term Period) + 30 days

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Intervention	Participants (Number)
	>=1 AE	>=1 Hypoglycemia	>=1 Related AEs	Deaths	SAEs	>=1 related SAE	SAEs leading to discontinuation	AE leading to discontinuation	Hypoglycemia leading to discontinuation
Group 1: Dapagliflozin Placebo, AM & PM	58	4	15	0	5	0	1	4	0
Group 1: Dapagliflozin, 10 mg AM	56	3	17	1	1	0	0	5	0
Group 1: Dapagliflozin, 10 mg PM	54	2	21	0	3	0	1	7	0
Group 1: Dapagliflozin, 2.5 mg AM	48	3	13	0	6	0	0	4	0
Group 1: Dapagliflozin, 2.5 mg PM	50	2	19	1	7	0	1	2	0
Group 1: Dapagliflozin, 5 mg AM	43	0	10	0	4	0	1	4	0
Group 1: Dapagliflozin, 5 mg PM	50	0	18	1	5	0	2	6	0
Group 2: Dapagliflozin, 10 mg AM	33	1	10	0	0	0	0	1	0
Group 2: Dapagliflozin, 5 mg AM	29	1	12	0	1	0	0	0	0

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Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528372)
Timeframe: From Baseline to Week 24 (end of Short-term Period)

Intervention	Kilograms (Mean)
Group 1: Dapagliflozin Placebo AM & PM	-2.19
Group 1: Dapagliflozin, 2.5 mg AM	-3.25
Group 1: Dapagliflozin, 5 mg AM	-2.83
Group 1: Dapagliflozin, 10 mg AM	-3.16
Group 1: Dapagliflozin, 2.5 mg PM	-3.82
Group 1: Dapagliflozin, 5 mg PM	-3.55
Group 1: Dapagliflozin, 10 mg PM	-3.05

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Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)

Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Day 1 to Week 102 (end of Long-term Period)

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Intervention	Participants (Number)
	AST >3*ULN (n=75, 65, 62, 70, 67, 67, 74, 34, 37))	AST >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	ALT >3*ULN (n=75, 65, 62, 70, 67, 67, 74)	ALT >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	Bilirubin >1.5 ULN (n=75, 65, 62, 70, 67, 67, 74)	Bilirubin >2*ULN (n=75, 65, 62, 70, 67, 67, 74)	ALP >1.5*ULN (n=75, 65, 62, 70, 67, 67, 74)
Group 1: Dapagliflozin Placebo AM & PM	0	0	1	0	2	0	4
Group 1: Dapagliflozin, 10 mg AM	0	0	1	0	0	0	1
Group 1: Dapagliflozin, 10 mg PM	4	0	0	0	0	0	2
Group 1: Dapagliflozin, 2.5 mg AM	1	0	1	1	0	0	3
Group 1: Dapagliflozin, 2.5 mg PM	5	2	0	0	2	1	4
Group 1: Dapagliflozin, 5 mg AM	1	0	2	0	1	0	1
Group 1: Dapagliflozin, 5 mg PM	1	0	0	0	1	0	3

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528372)
Timeframe: Baseline to Week 1 (end of Short-term Period)

Intervention	mg/dL (Mean)
Group 1: Dapagliflozin Placebo AM & PM	-2.4
Group 1: Dapagliflozin, 2.5 mg AM	-2.9
Group 1: Dapagliflozin, 5 mg AM	-16.4
Group 1: Dapagliflozin, 10 mg AM	-16.1
Group 1: Dapagliflozin, 2.5 mg PM	-14.4
Group 1: Dapagliflozin, 5 mg PM	-18.6
Group 1: Dapagliflozin, 10 mg PM	-20.3

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528372)
Timeframe: Baseline to Week 1

Intervention	mg/dL (Mean)
Group 2: Dapagliflozin, 5 mg AM	-54.3
Group 2: Dapagliflozin, 10 mg AM	-74.3

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Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)

Intervention	Percent (Mean)
Group 1: Dapagliflozin Placebo AM & PM	-0.21
Group 1: Dapagliflozin, 2.5 mg AM	-0.58
Group 1: Dapagliflozin, 5 mg AM	-0.73
Group 1: Dapagliflozin, 10 mg AM	-0.88
Group 1: Dapagliflozin, 2.5 mg PM	-0.81
Group 1: Dapagliflozin, 5 mg PM	-0.76
Group 1: Dapagliflozin, 10 mg PM	-0.80

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Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2

Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)

Intervention	mg/dL (Mean)
Group 2: Dapagliflozin, 5 mg AM	-77.
Group 2: Dapagliflozin, 10 mg AM	-84.3

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Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])

12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)

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Intervention	Participants (Number)
	Baseline: Normal/Week 24: Normal	Baseline: Normal/Week 24: Abnormal	Baseline: Normal/Week 24: Not reported	Baseline: Abnormal/Week 24: Normal	Baseline: Abnormal/Week 24: Abnormal	Baseline: Abnormal/Week 24: Not reported	Baseline: Not reported/Week 24: Normal	Basline: Not reported/Week 24: Abnormal	Baseline: Not reported/Week 24: Not reported
Group 1: Dapagliflozin Placebo AM & PM	38	6	0	5	18	0	0	0	8
Group 1: Dapagliflozin, 10 mg AM	31	1	0	6	17	0	0	0	15
Group 1: Dapagliflozin, 10 mg PM	35	10	0	10	11	0	0	0	10
Group 1: Dapagliflozin, 2.5 mg AM	36	3	0	2	17	0	0	0	7
Group 1: Dapagliflozin, 2.5 mg PM	33	3	0	4	17	0	0	0	10
Group 1: Dapagliflozin, 5 mg AM	32	5	0	3	11	0	0	0	13
Group 1: Dapagliflozin, 5 mg PM	33	6	0	4	14	0	0	0	11

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Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)

Intervention	mg/dL (Mean)
Group 1: Dapagliflozin Placebo AM & PM	-4.1
Group 1: Dapagliflozin, 2.5 mg AM	-15.2
Group 1: Dapagliflozin, 5 mg AM	-24.1
Group 1: Dapagliflozin, 10 mg AM	-28.8
Group 1: Dapagliflozin, 2.5 mg PM	-25.6
Group 1: Dapagliflozin, 5 mg PM	-27.3
Group 1: Dapagliflozin, 10 mg PM	-29.6

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Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available) was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)

Intervention	Kilograms (Mean)
Group 1: Dapagliflozin Placebo AM & PM	-2.43
Group 1: Dapagliflozin, 2.5 mg AM	-3.43
Group 1: Dapagliflozin, 5 mg AM	-2.91
Group 1: Dapagliflozin, 10 mg AM	-3.39
Group 1: Dapagliflozin, 2.5 mg PM	-4.30
Group 1: Dapagliflozin, 5 mg PM	-3.70
Group 1: Dapagliflozin, 10 mg PM	-3.39

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Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1

HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)

Intervention	Percent (Mean)
Group 1: Dapagliflozin Placebo AM & PM	-0.23
Group 1: Dapagliflozin, 2.5 mg AM	-0.58
Group 1: Dapagliflozin, 5 mg AM	-0.77
Group 1: Dapagliflozin, 10 mg AM	-0.89
Group 1: Dapagliflozin, 2.5 mg PM	-0.83
Group 1: Dapagliflozin, 5 mg PM	-0.79
Group 1: Dapagliflozin, 10 mg PM	-0.79

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Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had baseline HbA1c >9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study drug. In cases where time of the first dose or assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study drug. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)

Intervention	Percent (Mean)
Group 1: Dapagliflozin Placebo AM & PM	0.19
Group 1: Dapagliflozin, 2.5 mg AM	-1.26
Group 1: Dapaglifozon, 5 mg AM	-2.00
Group 1: Dapagliflozin, 10 mg AM	-2.04
Group 1: Dapagliflozin, 2.5 mg PM	-1.35
Group 1: Dapagliflozin, 5 mg PM	-1.53
Group 1: Dapagliflozin, 10 mg PM	-1.21

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Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2

HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c >10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. (NCT00528372)
Timeframe: Baseline to Week 24 (end of Short-term Period)

Intervention	Percent (Mean)
Group 2: Dapagliflozin, 5 mg AM	-2.88
Group 2: Dapagliflozin, 10 mg AM	-2.66

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Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])

12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. (NCT00528879)
Timeframe: Baseline to Week 102

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Intervention	Participants (Number)
	Baseline normal/Week 102 normal	Baseline normal/Week 102 abnormal	Baseline normal/Week 102 not reported	Baseline abnormal/Week 102 normal	Baseline abnormal/Week 102 abnormal	Baseline abnormal/Week 102 not reported	Baseline not reported/Week 102 normal	Baseline not reportedl/Week 102 abnormal	Baseline not reported/Week 102 not reported
Dapagliflozin, 10 mg + Metformin	82	8	9	10	25	1	0	0	0
Dapagliflozin, 2.5 mg + Metformin	80	14	6	11	24	2	0	0	0
Dapagliflozin, 5 mg + Metformin	79	9	5	20	20	3	1	0	0
Placebo + Metformin	74	7	9	17	26	3	1	0	0

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Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality

BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value. (NCT00528879)
Timeframe: Day 1 to Week 102

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Intervention	Participants (Number)
	Hematocrit >55%	Hemoglobin >18 g/dL	BUN ≥60 mg/d or Urea>21.4 mmol/L	Creatinine ≥1.5 preRX creatinine	Creatinine ≥2.5 mg/dL	Glucose >350 mg/dL	Creatine kinase >5*ULN	Creatine kinase >10*ULN	Calcium, total <7.5 mg/dL	Calcium, total (high)	Potassium, serum ≥6 MEQ/L	Magnesium, serum <1 mEq/L	Sodium, serum <130 mEq/L	Sodium, serum >150 mEq/L	Phosphorus, inorganic (high)	Phosphorus, inorganic (low)	Albumin/creatinine ratio >1800 mg/g	AST elevation 3*ULN	ALT elevation 3*ULN	ALT elevation 5*ULN	Total bilirubin elevation >1.5*ULN	Total bilirubin elevation >2*ULN	ALP elevation >1.5*ULN
Dapagliflozin, 10 mg + Metformin	3	5	1	2	0	1	3	1	0	0	2	1	0	0	5	0	1	2	2	0	4	1	2
Dapagliflozin, 2.5 mg + Metformin	2	4	0	3	0	0	2	0	1	0	3	0	0	0	1	0	0	0	3	0	1	0	5
Dapagliflozin, 5 mg + Metformin	2	1	0	4	1	0	3	2	2	0	3	0	3	1	2	0	3	3	2	1	1	0	0
Placebo + Metformin	1	1	0	2	0	2	2	1	4	2	6	1	1	0	1	1	2	0	1	0	2	0	5

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Number of Participants With Orthostatic Hypotension

Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure. (NCT00528879)
Timeframe: From Baseline to Week 102

,,,

Intervention	Participants (Number)
	Baseline (n=121, 127, 124, 126)	Week 1 (n=126, 121, 119, 114)	Week 12 (n=123, 128, 127, 125)	Week 24 (n=116, 114, 118, 121)	Week 50 (n=103, 115, 109,112)	Week 102 (n=71, 76, 87, 94)
Dapagliflozin, 10 mg + Metformin	4	19	5	3	6	3
Dapagliflozin, 2.5 mg + Metformin	4	26	8	6	6	1
Dapagliflozin, 5 mg + Metformin	4	21	4	5	7	1
Placebo + Metformin	3	28	6	10	10	1

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528879)
Timeframe: From Baseline to Week 1

Intervention	mg/dL (Mean)
Placebo + Metformin	1.2
Dapagliflozin, 2.5 mg + Metformin	-6.0
Dapagliflozin, 5 mg + Metformin	-12.0
Dapagliflozin, 10 mg + Metformin	-16.5

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528879)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
Placebo + Metformin	-6.0
Dapagliflozin, 2.5 mg + Metformin	-17.8
Dapagliflozin, 5 mg + Metformin	-21.5
Dapagliflozin, 10 mg + Metformin	-23.5

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Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528879)
Timeframe: From Baseline to Week 24

Intervention	Percent (Mean)
Placebo + Metformin	-0.31
Dapagliflozin, 2.5 mg + Metformin	-0.69
Dapagliflozin, 5 mg + Metformin	-0.71
Dapagliflozin, 10 mg + Metformin	-0.88

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Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528879)
Timeframe: From Baseline to Week 24

Intervention	Percent (Mean)
Placebo + Metformin	-0.53
Dapagliflozin, 2.5 mg + Metformin	-1.21
Dapagliflozin, 5 mg + Metformin	-1.37
Dapagliflozin, 10 mg + Metformin	-1.32

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Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00528879)
Timeframe: From Baseline to Week 24

Intervention	Kilograms (Mean)
Placebo + Metformin	-0.89
Dapagliflozin, 2.5 mg + Metformin	-2.21
Dapagliflozin, 5 mg + Metformin	-3.04
Dapagliflozin, 10 mg + Metformin	-2.86

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Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00528879)
Timeframe: From Baseline to Week 24

Intervention	Kilograms (Mean)
Placebo + Metformin	-1.01
Dapagliflozin, 2.5 mg + Metformin	-2.39
Dapagliflozin, 5 mg + Metformin	-3.21
Dapagliflozin, 10 mg + Metformin	-3.09

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Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT00528879)
Timeframe: From Baseline to Week 24

Intervention	Percentage of participants (Number)
Placebo + Metformin	13.8
Dapagliflozin, 2.5 mg + Metformin	20.7
Dapagliflozin, 5 mg + Metformin	14.5
Dapagliflozin, 10 mg + Metformin	25.2

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Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT00528879)
Timeframe: From Baseline to Week 24

Intervention	Percentage of participants (Number)
Placebo + Metformin	25.9
Dapagliflozin, 2.5 mg + Metformin	33.0
Dapagliflozin, 5 mg + Metformin	37.5
Dapagliflozin, 10 mg + Metformin	40.6

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Mean Changes From Baseline in Seated Diastolic Blood Pressure

Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00528879)
Timeframe: From Baseline to Week 102

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Intervention	mm Hg (Mean)
	Week 12 (n=125, 129, 129, 126)	Week 24 (n=119, 119, 122, 122)	Week 50 (n=105, 116, 111, 113)	Week 102 (n=72, 78, 88, 94)
Dapagliflozin, 10 mg + Metformin	-1.0	-1.8	-1.2	-1.2
Dapagliflozin, 2.5 mg + Metformin	-1.3	-1.8	-0.2	-0.1
Dapagliflozin, 5 mg + Metformin	-2.3	-2.5	-2.4	-1.5
Placebo + Metformin	-0.9	-0.1	0.1	-1.0

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Mean Changes From Baseline in Seated Systolic Blood Pressure

,,,

Intervention	mm Hg (Mean)
	Week 12 (n=125, 129, 129, 126)	Week 24 (n=119, 119, 122, 122)	Week 50 (n=105, 116, 111, 113)	Week 102 (n=72, 78, 88, 94)
Dapagliflozin, 10 mg + Metformin	-3.0	-5.1	-1.9	-0.3
Dapagliflozin, 2.5 mg + Metformin	-1.6	-2.1	-0.1	0.7
Dapagliflozin, 5 mg + Metformin	-4.0	-4.3	-2.1	-1.1
Placebo + Metformin	-0.1	-0.2	1.0	1.5

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Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included. (NCT00528879)
Timeframe: From Baseline to end of Long-term Period (Week 102)

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Intervention	Participants (Number)
	At least 1 AE	At least 1 hypoglycemia event	At least 1 related AE	Deaths	At least 1 SAE	At least 1 related SAE	SAEs leading to discontinuation	AEs leading to discontinuation	Hypoglycemia events leading to discontinuation
Dapagliflozin, 10 mg + Metformin	111	7	45	0	14	1	2	6	0
Dapagliflozin, 2.5 mg + Metformin	111	5	36	2	15	0	3	7	0
Dapagliflozin, 5 mg + Metformin	111	7	33	0	9	2	1	5	0
Placebo + Metformin	111	8	28	1	14	3	6	9	0

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period. (NCT00528879)
Timeframe: From Baseline to Week 24

Intervention	Percent (Mean)
Placebo + Metformin	-0.30
Dapagliflozin, 2.5 mg + Metformin	-0.67
Dapagliflozin, 5 mg + Metformin	-0.70
Dapagliflozin, 10 mg + Metformin	-0.84

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Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

Intervention	Percentage of participants (Mean)
Dapagliflozin 5 mg + Metformin XR	52.4
Dapagliflozin 5 mg	22.5
Metformin XR	34.6

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Adjusted Mean Change From Baseline in Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00643851)
Timeframe: From Baseline to Week 24

Intervention	kg (Mean)
Dapagliflozin 5 mg + Metformin XR	-3.04
Dapagliflozin 5 mg	-2.88
Metformin XR	-1.47

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% at Week 24 (Last Observation Carried Forward [LOCF])

Intervention	% of hemoglobin (Mean)
Dapagliflozin 5 mg + Metformin XR	-3.01
Dapagliflozin 5 mg	-1.67
Metformin XR	-1.82

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the double-blind period. (NCT00643851)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
Dapagliflozin 5 mg + Metformin XR	-61.0
Dapagliflozin 5 mg	-42.0
Metformin XR	-33.6

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double- blind period. (NCT00643851)
Timeframe: From Baseline to Week 24

Intervention	% of hemoglobin (Mean)
Dapagliflozin 5 mg + Metformin XR	-2.05
Dapagliflozin 5 mg	-1.19
Metformin XR	-1.35

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Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00643851)
Timeframe: From Baseline to Week 24

Intervention	kg (Mean)
Dapagliflozin 5 mg + Metformin XR	-2.66
Dapagliflozin 5 mg	-2.61
Metformin XR	-1.29

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Adjusted Mean Change in Body Weight

To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment. (NCT00660907)
Timeframe: Baseline to Week 52

Intervention	kg (Least Squares Mean)
Dapagliflozin Plus Metformin	-3.22
Glipizide Plus Metformin	1.44

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Adjusted Mean Change in HbA1c Levels

To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone. (NCT00660907)
Timeframe: Baseline to Week 52

Intervention	percent (Least Squares Mean)
Dapagliflozin Plus Metformin	-0.52
Glipizide Plus Metformin	-0.52

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Proportion of Participants With Body Weight Reduction of at Least 5%

To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value. (NCT00660907)
Timeframe: Baseline to Week 52

Intervention	Percentage of participants (Least Squares Mean)
Dapagliflozin Plus Metformin	33.3
Glipizide Plus Metformin	2.5

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Proportion of Participants With at Least One Episode of Hypoglycemia

To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value. (NCT00660907)
Timeframe: Baseline to Week 52

Intervention	Percentage of participants (Least Squares Mean)
Dapagliflozin Plus Metformin	3.5
Glipizide Plus Metformin	40.8

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Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00663260)
Timeframe: From Baseline to Week 24

Intervention	kg (Mean)
Placebo	0.27
Dapagliflozin 5 mg	-1.54
Dapagliflozin 10 mg	-1.89

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period. (NCT00663260)
Timeframe: From Baseline to Week 24

Intervention	% of hemoglobin (Mean)
Placebo	-0.32
Dapagliflozin 5 mg	-0.41
Dapagliflozin 10 mg	-0.44

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period (NCT00663260)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
Placebo	8.4
Dapagliflozin 5 mg	-5.2
Dapagliflozin 10 mg	-0.6

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Proportion of Participants With Lack of Glycemic Control

Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets (NCT00673231)
Timeframe: Baseline to Week 24

Intervention	Participants (Number)
Placebo	54
Dapagliflozin 2.5mg	22
Dapagliflozin 5mg	24
Dapagliflozin 10mg	19

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Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction

To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment. (NCT00673231)
Timeframe: Baseline to Week 24

Intervention	Percentage of participants (Least Squares Mean)
Placebo	11.0
Dapagliflozin 2.5mg	18.1
Dapagliflozin 5mg	16.8
Dapagliflozin 10mg	19.7

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Adjusted Mean Change in HbA1c Levels

To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24

Intervention	Percent (Least Squares Mean)
Placebo	-0.30
Dapagliflozin 2.5mg	-0.75
Dapagliflozin 5mg	-0.82
Dapagliflozin 10mg	-0.90

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Adjusted Mean Change in Fasting Plasma Glucose (FPG)

To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24

Intervention	mg/dL (Least Squares Mean)
Placebo	3.3
Dapagliflozin 2.5mg	-12.5
Dapagliflozin 5mg	-18.8
Dapagliflozin 10mg	-21.7

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Adjusted Mean Change in Calculated Mean Daily Insulin Dose

To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24

Intervention	IU/day (Least Squares Mean)
Placebo	5.08
Dapagliflozin 2.5mg	-1.80
Dapagliflozin 5mg	-0.61
Dapagliflozin 10mg	-1.16

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Adjusted Mean Change in Body Weight

To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration. (NCT00673231)
Timeframe: Baseline to Week 24

Intervention	kg (Least Squares Mean)
Placebo	0.02
Dapagliflozin 2.5mg	-0.98
Dapagliflozin 5mg	-0.98
Dapagliflozin 10mg	-1.67

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Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride. (NCT00680745)
Timeframe: At Week 24

Intervention	Percentage of participants (Least Squares Mean)
Dapagliflozin 2.5mg + Glimepiride	26.8
Dapagliflozin 5mg + Glimepiride	30.3
Dapagliflozin 10mg + Glimepiride	31.7
Placebo + Glimepiride	13.0

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Adjusted Mean Change in HbA1c Levels

To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period. (NCT00680745)
Timeframe: Baseline to Week 24

Intervention	Percent (Least Squares Mean)
Dapagliflozin 2.5mg + Glimepiride	-0.58
Dapagliflozin 5mg + Glimepiride	-0.63
Dapagliflozin 10mg + Glimepiride	-0.82
Placebo + Glimepiride	-0.13

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Adjusted Mean Change in Fasting Plasma Glucose (FPG)

To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride. (NCT00680745)
Timeframe: Baseline to Week 24

Intervention	mg/dL (Least Squares Mean)
Dapagliflozin 2.5mg + Glimepiride	-16.8
Dapagliflozin 5mg + Glimepiride	-21.2
Dapagliflozin 10mg + Glimepiride	-28.5
Placebo + Glimepiride	-2.0

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Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2

To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride. (NCT00680745)
Timeframe: Baseline to Week 24

Intervention	kg (Least Squares Mean)
Dapagliflozin 2.5mg + Glimepiride	-1.17
Dapagliflozin 5mg + Glimepiride	-1.74
Dapagliflozin 10mg + Glimepiride	-2.47
Placebo + Glimepiride	-0.80

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Adjusted Mean Change in Body Weight

To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride. (NCT00680745)
Timeframe: Baseline to Week 24

Intervention	kg (Least Squares Mean)
Dapagliflozin 2.5mg + Glimepiride	-1.18
Dapagliflozin 5mg + Glimepiride	-1.56
Dapagliflozin 10mg + Glimepiride	-2.26
Placebo + Glimepiride	-0.72

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Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise

To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24. (NCT00680745)
Timeframe: Baseline to Week 24

Intervention	mg/dL (Least Squares Mean)
Dapagliflozin 2.5mg + Glimepiride	-37.5
Dapagliflozin 5mg + Glimepiride	-32.0
Dapagliflozin 10mg + Glimepiride	-34.9
Placebo + Glimepiride	-6.0

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

Intervention	% of hemoglobin (Mean)
PLACEBO + Pioglitazone	-0.42
Dapagliflozin 5MG + Pioglitazone	-0.82
Dapagliflozin 10MG + Pioglitazone	-0.97

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Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

Intervention	Percentage of participants (Mean)
PLACEBO + Pioglitazone	22.4
Dapagliflozin 5MG + Pioglitazone	32.5
Dapagliflozin 10MG + Pioglitazone	38.8

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Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Intervention	kg (Mean)
PLACEBO + Pioglitazone	1.64
Dapagliflozin 5MG + Pioglitazone	0.09
Dapagliflozin 10MG + Pioglitazone	-0.14

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Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Intervention	kg (Mean)
PLACEBO + Pioglitazone	1.83
Dapagliflozin 5MG + Pioglitazone	0.26
Dapagliflozin 10MG + Pioglitazone	-0.07

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
PLACEBO + Pioglitazone	-5.5
Dapagliflozin 5MG + Pioglitazone	-24.9
Dapagliflozin 10MG + Pioglitazone	-29.6

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Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained on Day 1 and week 24 in the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
PLACEBO + Pioglitazone	-14.1
Dapagliflozin 5MG + Pioglitazone	-65.1
Dapagliflozin 10MG + Pioglitazone	-67.5

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Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in waist circumference at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period. (NCT00683878)
Timeframe: From Baseline to Week 24

Intervention	cm (Mean)
PLACEBO + Pioglitazone	1.38
Dapagliflozin 5MG + Pioglitazone	0.52
Dapagliflozin 10MG + Pioglitazone	-0.17

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Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants

12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -14 for this parameter. (NCT00736879)
Timeframe: Week 24

,,,

Intervention	participants (Number)
	Normal at BL, Normal at Week 24 (N=68, 72, 74, 68)	Abnormal BL, Normal at Week 24(N=68, 72, 74, 68)	Normal BL, Abnormal at Week 24(N=68, 72, 74, 68)	Abnormal BL, Abnormal at Week 24(N=68, 72, 74, 68)	Reported at BL, Not Reported at Week 24
1mg Dapagliflozin	38	5	3	23	3
2.5 mg Dapagliflozin	43	4	4	14	9
5 mg Dapagliflozin	38	7	1	16	6
Placebo	34	10	4	16	4

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Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants

Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period. Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue was also included. Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); BUN (>60 mg/dL) or Urea >21.4 mmol/L; creatinine (>=1.5*preRX, >=2.5 mg/dL); AST and ALT >3*ULN; bilirubin >1.5*ULN; ALP >1.5*ULN. (NCT00736879)
Timeframe: Baseline to Week 24/end of treatment plus 4 days

,,,

Intervention	participants (Number)
	Hematocrit High >55% (N=68, 72, 74, 67)	Hemoglobin High >18 g/dL(N=68, 72, 74, 67)	Creatinine High >=1.5*PreRX(N=68, 72, 74, 67)	AST 3*ULN (N=68, 72, 74, 67)	ALT 3*ULN (N=68, 72, 74, 67)	ALT 5*ULN (N=68, 72, 74, 67)	AST or ALT >3*ULN (N=68, 72, 74, 67)	AST or ALT >5*ULN (N=68, 72, 74, 67)	Total bilirubin >1.5*ULN (N=68, 72, 74, 67)	Total bilirubin >2*ULN (N=68, 72, 74, 67)	ALP >1.5*ULN (N=68, 72, 74, 67)	ALP >3*ULN (N=68, 72, 74, 67)	Glucose >350 mg/dL (N=68, 72, 74, 67)	Creatinine Kinase > 5X ULN (N=68, 72, 74, 67)	Calcium <7.5 mg/dL (N=68, 72, 74, 67)	Calcium (mg/dL) >=1 vs ULN and >=0.5 vs baseline	Potassium >= 6 meq/L (N=68, 72, 74, 67)	Magnesium <1 meq/L (N=68, 72, 74, 67)	Sodium <130 meq/L (N=68, 72, 74, 67)	Sodium >150 meq/L (N=68, 72, 74, 67)	Sodium < 120 meq/L
1mg Dapagliflozin	0	1	1	1	1	1	1	1	0	0	3	0	1	3	2	0	0	1	1	0	0
2.5 mg Dapagliflozin	1	1	1	0	0	0	0	0	1	0	1	0	0	0	0	0	2	0	0	1	0
5 mg Dapagliflozin	0	1	4	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0
Placebo	0	1	2	1	1	1	1	1	2	1	1	1	1	0	1	1	0	1	1	0	1

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Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants

Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs. Data after rescue included. (NCT00736879)
Timeframe: Day 1 of Double Blind Period to end of Week 24 Plus 30 days

,,,

Intervention	participants (Number)
	Death	Serious Adverse Event (SAE)	Related SAE	Adverse Event (AE)	Related Adverse Event	Discontinued due to AE
Dapagliflozin 1mg	0	2	2	42	5	1
Dapagliflozin 2.5 mg	0	2	0	43	9	1
Dapagliflozin 5 mg	0	0	0	39	5	0
Placebo	0	0	0	41	8	0

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Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants

Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue. Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor. (NCT00736879)
Timeframe: Baseline to last dose plus 4 days in 12 Week Double Blind Period

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Intervention	participants (Number)
	Cardiac Disorders AEs	Vascular Disorders AEs	Hypoglycemia AEs (excluding data after rescue)	Major hypoglycemic episode	Minor hypoglycemic episode	Other hypoglycemic episode	AE Suggestive of Genital Infection	AE Suggestive of UTI	AE of Renal Impairment (creatinine increased)	AE of Hypotension	AE of Fracture	AE of Urinary Stones
1mg Dapagliflozin	0	1	0	0	0	0	1	3	0	0	0	0
2.5 mg Dapagliflozin	4	2	1	0	0	1	5	1	0	0	0	1
5 mg Dapagliflozin	0	1	1	0	0	1	2	2	0	1	0	0
Placebo	0	4	0	0	0	0	2	1	2	0	3	1

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Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants

Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Blood pressure was measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00736879)
Timeframe: Baseline (Day 1), Week 24

,,,

Intervention	mmHg (Mean)
	Systolic Blood Pressure (n=65, 68, 65, 62)	Diastolic Blood Pressure (n=65, 68, 65, 62)
Dapagliflozin 1mg	-3.7	-1.1
Dapagliflozin 2.5 mg	-3.1	-2.0
Dapagliflozin 5 mg	-4.6	-1.9
Placebo	0.8	0.2

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Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants

Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00736879)
Timeframe: Baseline (Day 1), Week 24

Intervention	bpm (Mean)
Placebo	-1.3
1mg Dapagliflozin	-2.0
2.5 mg Dapagliflozin	-1.6
5 mg Dapagliflozin	-1.4

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Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants

Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication (metformin) was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT00736879)
Timeframe: Baseline (Day 1), Week 24

Intervention	Adjusted Percentage of participants (Number)
Placebo	34.6
Dapagliflozin 1mg	53.6
Dapagliflozin 2.5 mg	43.4
Dapagliflozin 5 mg	49.1

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Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants

Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation carried forward, (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00736879)
Timeframe: Baseline (Day 1), Week 24

Intervention	cm (Mean)
Placebo	-1.70
Dapagliflozin 1mg	-2.50
Dapagliflozin 2.5 mg	-2.31
Dapagliflozin 5 mg	-3.17

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Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants

Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period. (NCT00736879)
Timeframe: Baseline (Day 1), Week 24

Intervention	Percent Hemoglobin (Mean)
Placebo	0.02
Dapagliflozin 1mg	-0.68
Dapagliflozin 2.5 mg	-0.72
Dapagliflozin 5 mg	-0.82

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants

Adjusted mean change in fasting plasma glucose (FPG) from baseline at Week 24 (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00736879)
Timeframe: Baseline (Day 1), Week 24

Intervention	mg/dL (Mean)
Placebo	4.1
Dapagliflozin 1mg	-11.0
Dapagliflozin 2.5 mg	-21.6
Dapagliflozin 5 mg	-28.5

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Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants

Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control. At Week 24, study treatment was given 1 hour before MTT was administered. Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT. The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn. Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement. Glucose was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study medication. (NCT00736879)
Timeframe: Baseline (Day 1), Week 24

Intervention	mg/dL (Mean)
Placebo	8.81
Dapagliflozin 1mg	-33.3
Dapagliflozin 2.5 mg	-39.3
Dapagliflozin 5 mg	-51.8

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Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants

Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. (NCT00736879)
Timeframe: Baseline (Day 1), Week 24

Intervention	kg (Mean)
Placebo	-0.96
Dapagliflozin 1mg	-2.69
Dapagliflozin 2.5 mg	-2.64
Dapagliflozin 5 mg	-2.69

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Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])

Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period. (NCT00831779)
Timeframe: From Baseline to Week 12

Intervention	mU/L*min (Mean)
Placebo + Background Anti-Diabetes Medication	-12.73
Dapagliflozin 5 mg + Background Anti-Diabetes Medication	15.39

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Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])

Intervention	% Change of Baseline Insulin Sensitivity (Mean)
Placebo + Background Anti-Diabetes Medication	-9.99
Dapagliflozin 5 mg + Background Anti-Diabetes Medication	7.98

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Adjusted Mean Change in Body Fat Mass

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry. (NCT00855166)
Timeframe: Baseline to Week 24

Intervention	kg (Least Squares Mean)
Placebo Plus Metformin	-0.74
Dapagliflozin Plus Metformin	-2.22

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Adjusted Mean Change in Total Body Weight

To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment. (NCT00855166)
Timeframe: Baseline to Week 24

Intervention	kg (Least Squares Mean)
Placebo Plus Metformin	-0.88
Dapagliflozin Plus Metformin	-2.96

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Adjusted Mean Change in Waist Circumference

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference. (NCT00855166)
Timeframe: Baseline to Week 24

Intervention	cm (Least Squares Mean)
Placebo Plus Metformin	-0.99
Dapagliflozin Plus Metformin	-2.51

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Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry. (NCT00855166)
Timeframe: Baseline to Week 102

Intervention	Percent (Least Squares Mean)
Placebo Plus Metformin	0.09
Dapagliflozin Plus Metformin	-0.85

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Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry. (NCT00855166)
Timeframe: Baseline to Week 102

Intervention	Percent (Least Squares Mean)
Placebo Plus Metformin	0.47
Dapagliflozin Plus Metformin	0.69

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Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry. (NCT00855166)
Timeframe: Baseline to Week 102

Intervention	Percent (Least Squares Mean)
Placebo Plus Metformin	-0.37
Dapagliflozin Plus Metformin	-0.82

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Proportion of Participants With Body Weight Decrease ≥5%

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value. (NCT00855166)
Timeframe: Baseline to Week 24

Intervention	Percentage of participants (Least Squares Mean)
Placebo Plus Metformin	4.3
Dapagliflozin Plus Metformin	30.6

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Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants

Laboratory samples: Qualification and Lead-In Periods, Day 1, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of Double-Blind Period. Baseline (BL)=last assessment prior to start of first dose of double-blind study medication. Data after rescue included. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); Units per liter (U/L), blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose <54 (>350) mg/dL; creatine kinase (>5*ULN);calcium <7.5 (>=1 mg/dL from ULN and >= 0.5mg/dL from PreRX); sodium <130 or < 120 male/female (>150 mEq/L; potassium <=2.5 (>=6.0) mEq/L; bicarbonate <= 13 mEq/L; inorganic phosphorus: <=1.8 if age 17-65 or <=2.1 if age >=66, (>=5.6 if age 17-65 or >=5.1) mg/dL if age >=66; albumin <=2 (>6) g/dL; urine albumin(alb) / creatinine (creat) ratio (>1800 mg/g) (NCT00859898)
Timeframe: Baseline to Week 24/end of treatment plus 4 days

Intervention	participants (Number)
	Hematocrit High > 55% (N=209, 218, 206)	Hemoglobin High >18 g/dL(N=209, 218, 207)	Creatinine >1.5*PreRX (N=209, 218, 207)	Glucose High > 350 mg/dL (N=209, 218, 207)	Albumin low or high (N=209, 218, 207)	Calcium Low <7.5mg/dL (N=209, 218, 207)	Calcium High >=1mg/dL+ULN (N=209, 218, 207)	Bicarbonate Low <=13mEq/L (N=209, 218, 207)	Potassium High >=6 mEq/L (N=209, 218, 207)	Sodium Low <130 mEq/L (N=209, 218, 207)	Sodium High >150 mEq/L (N=209, 218, 207)	Sodium Low <120 mEq/L (N=209, 218, 207)	inorganic phosphorus (high)(N=209, 218, 207)	Urine albumin/creat ratio (high)(N=209, 218, 206)
Dapagliflozin	4	4	2	2	0	2	2	0	3	2	5	1	13	3
Dapagliflozin + Metformin XR	1	5	8	1	0	1	0	3	2	2	5	0	7	0
Metformin XR	1	1	5	3	0	1	0	0	6	2	2	0	3	1

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Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants

Safety laboratory measurements were obtained during the Qualification and Lead-In Periods and on Day 1 of the Double-Blind Period and at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. BL was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from BL up to and including the last day of treatment plus 30 days. Liver function abnormality criteria: FDA Guidance for Industry: Premarketing Clinical Evaluation (July 2009). Data after rescue was also included. Abbreviations: Pretreatment (PreRX), upper limit of normal (ULN); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality Low (High) defined: ALP, AST and ALT (>3*ULN); bilirubin (>2*ULN if PreRX <= ULN; >3*ULN if PreRX > ULN); AST or ALT plus (+) bilirubin elevation: AST or ALT >3*ULN and bilirubin >1.5*ULN within 14 days on or after ALT elevation. (NCT00859898)
Timeframe: Baseline to Week 24/end of treatment plus 30 days

Intervention	participants (Number)
	AST >3*ULN (N=210, 219, 208)	AST >5*ULN (N=210, 219, 208)	ALT >3*ULN (N=210, 219, 208)	ALT >5*ULN (N=210, 219, 208)	ALT >10*ULN (N=210, 219, 208)	AST or ALT > 3*ULN (N=210, 219, 208)	AST or ALT > 5*ULN (N=210, 219, 208)	AST or ALT > 10*ULN (N=210, 219, 208)	Total bilirubin >1.5*ULN (N=210, 219, 207)	AST or ALT + Bilirubin (High) (N=210, 219, 208)	ALP >1.5*ULN (N=210, 219, 208)	ALP >3*ULN (N=210, 219, 208)
Dapagliflozin	3	1	4	1	0	5	1	0	2	0	4	0
Dapagliflozin + Metformin XR	2	0	2	0	0	3	0	0	0	0	5	0
Metformin XR	2	1	7	2	1	7	2	1	1	1	3	1

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Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants

12-Lead electrocardiograms (ECGs) were performed at entry into Lead-In Period Day -7 visit and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -7 for this parameter. Data after rescue included. (NCT00859898)
Timeframe: Week 24

Intervention	participants (Number)
	Normal at BL, Normal at Week 24 (N=211, 219, 208)	Abnormal BL, Normal at Week 24 (N=211, 219, 208)	Normal BL, Abnormal at Week 24 (N=211, 219, 208)	Abnormal BL, Abnormal at Week 24 (N=211, 219, 208)	Normal at BL, Not Reported at Week 24	Abnormal at BL, Not Reported at Week 24	Not Reported at BL, Abnormal at Week 24
Dapagliflozin	107	13	8	68	15	8	0
Dapagliflozin + Metformin XR	101	15	18	53	19	5	0
Metformin XR	94	22	9	59	15	8	1

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Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants

Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the Double-Blind Period. (NCT00859898)
Timeframe: Week 24

Intervention	Percent of hemoglobin (Mean)
Dapagliflozin + Metformin XR	-1.98
Dapagliflozin	-1.45
Metformin XR	-1.44

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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants

Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Data after rescue included. (NCT00859898)
Timeframe: Day 1 of Double Blind Period to end of Week 24 Plus 30 days

Intervention	participants (Number)
	Adverse Event (AE)	Related Adverse Event	Serious Adverse Event (SAE)	Related SAE	Discontinued due to AE	Deaths	Discontinued due to SAE
Dapagliflozin	132	47	5	1	9	0	1
Dapagliflozin + Metformin XR	126	34	3	0	4	0	0
Metformin XR	118	32	4	1	8	1	1

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Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants

Measurements were taken during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the Double Blind Period. Blood pressure values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Systolic and Diastolic pressures were measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00859898)
Timeframe: Week 24

Intervention	mmHg (Mean)
	Systolic (N=182, 185, 179)	Diastolic (N=182, 185, 179)
Dapagliflozin	-4.0	-1.9
Dapagliflozin + Metformin XR	-3.3	-1.8
Metformin XR	-1.2	0.0

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The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants

Adjusted mean change from baseline in total body weight at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg). Body weight measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the Double-Blind Period. (NCT00859898)
Timeframe: Week 24

Intervention	kg (Mean)
Dapagliflozin + Metformin XR	-3.33
Dapagliflozin	-2.73
Metformin XR	-1.36

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Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants

Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT00859898)
Timeframe: Week 24

Intervention	Percent of participants (Number)
Dapagliflozin + Metformin XR	46.6
Dapagliflozin	31.7
Metformin XR	35.5

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Mean Change From Baseline in Seated Heart Rate at Week 24 - Randomized, Treated Participants

Measurements were taken during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the Double Blind Period. Heart rate values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently throughout the study. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00859898)
Timeframe: Week 24

Intervention	bpm (Mean)
Dapagliflozin + Metformin XR	0.6
Dapagliflozin	-0.1
Metformin XR	0.5

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Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0%

HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized, treated participants whose Baseline HbA1c was greater than, equal to (>=) 9.0%. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. (NCT00859898)
Timeframe: Week 24

Intervention	Percent of Hemoglobin (Mean)
Dapagliflozin + Metformin XR	-2.59
Dapagliflozin	-2.14
Metformin XR	-2.05

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants

Data after rescue medication was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the Double-Blind Period. (NCT00859898)
Timeframe: Week 24

Intervention	mg/dL (Mean)
Dapagliflozin + Metformin XR	-60.4
Dapagliflozin	-46.4
Metformin XR	-34.8

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Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants

Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 13.0. Data after rescue included for all special AEs except hypoglycemia (excluded data after rescue). Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor. (NCT00859898)
Timeframe: Baseline to last dose plus 4 days in 12 Week Double Blind Period

Intervention	participants (Number)
	Cardiac Disorder AEs	Vascular Disorder AEs	Hypoglycemia AEs (excluding data after rescue)	Hypoglycemia Major Episode	Hypoglycemia Minor Episode	Hypoglycemia Other Episode	AEs Suggestive of Genital Infection	AEs Suggestive of UTI	AEs of Renal Impairment or Failure	AEs of Hypotension	AEs of Syncope	AEs of Fracture	AEs of Urinary Stones
Dapagliflozin	3	10	2	0	0	2	28	24	4	1	1	1	0
Dapagliflozin + Metformin XR	3	4	7	0	1	6	18	16	2	0	0	2	0
Metformin XR	5	8	6	0	1	5	5	9	1	0	0	0	1

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Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy (NCT00972244)
Timeframe: At Week 12

Intervention	Percentage of participants (Number)
1mg Dapagliflozin	1.7
2.5mg Dapagliflozin	9.3
5mg Dapagliflozin	5.2
10mg Dapagliflozin	9.6
Placebo	1.9

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Adjusted Mean Change in Fasting Plasma Glucose

Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available. (NCT00972244)
Timeframe: Baseline to Week 12

Intervention	mg/dL (Least Squares Mean)
1mg Dapagliflozin	-16.63
2.5mg Dapagliflozin	-19.97
5mg Dapagliflozin	-23.49
10mg Dapagliflozin	-31.92
Placebo	9.45

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Adjusted Mean Change in HbA1c Levels

The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available. (NCT00972244)
Timeframe: Baseline to Week 12

Intervention	percent (Least Squares Mean)
1mg Dapagliflozin	-0.12
2.5mg Dapagliflozin	-0.10
5mg Dapagliflozin	-0.37
10mg Dapagliflozin	-0.44
Placebo	0.35

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Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])

Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory. (NCT00976495)
Timeframe: From Baseline to Week 12

Intervention	% Change of Baseline GFR (Mean)
Placebo	-2.92
Dapagliflozin 10 mg	-10.76
Hydrochlorothiazide 25 mg	-3.40

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Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])

Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period. (NCT00976495)
Timeframe: From Baseline to Week 12

Intervention	mmHg (Mean)
Placebo	-1.55
Dapagliflozin 10 mg	-5.93
Hydrochlorothiazide 25 mg	-6.83

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Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])

Intervention	mmHg (Mean)
Placebo	-0.88
Dapagliflozin 10 mg	-3.28
Hydrochlorothiazide 25 mg	-6.55

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Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])

Intervention	mmHg (Mean)
Placebo	-0.61
Dapagliflozin 10 mg	-0.45
Hydrochlorothiazide 25 mg	-7.76

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Adjusted Mean Change in Body Weight

To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24. (NCT00984867)
Timeframe: Baseline to Week 24

Intervention	kg (Least Squares Mean)
Placebo	-0.26
Dapagliflozin	-2.14

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Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline

To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value. (NCT00984867)
Timeframe: Baseline to Week 24

Intervention	Percentage of participants (Least Squares Mean)
Placebo	16.6
Dapagliflozin	35.3

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Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg

To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8. (NCT00984867)
Timeframe: Baseline to Week 8

Intervention	mmHg (Least Squares Mean)
Placebo	-5.12
Dapagliflozin	-5.98

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Adjusted Mean Change in HbA1c Levels

To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin. (NCT00984867)
Timeframe: Baseline to Week 24

Intervention	Percent (Least Squares Mean)
Placebo	0.04
Dapagliflozin	-0.45

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Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%

To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24. (NCT00984867)
Timeframe: Baseline to Week 24

Intervention	Percent (Least Squares Mean)
Placebo	0.03
Dapagliflozin	-0.80

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Adjusted Mean Change in Fasting Plasma Glucose (FPG)

To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24. (NCT00984867)
Timeframe: Baseline to Week 24

Intervention	mg/dL (Least Squares Mean)
Placebo	3.81
Dapagliflozin	-24.11

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Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise

To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24. (NCT00984867)
Timeframe: Baseline to Week 24

Intervention	mg/dL (Least Squares Mean)
Placebo	-6.84
Dapagliflozin	-21.65

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Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²

To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum. (NCT01031680)
Timeframe: Baseline to Week 24

Intervention	Percentage of participants (Least Squares Mean)
Experimental	16.5
Placebo Comparator	4.0

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Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit

To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure. (NCT01031680)
Timeframe: Baseline to week 24

Intervention	Percentage of participants (Number)
Experimental	11.7
Placebo Comparator	0.9

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Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)

To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo. (NCT01031680)
Timeframe: Baseline to Week 24

Intervention	mmHg (Least Squares Mean)
Experimental	-2.99
Placebo Comparator	-1.03

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Adjusted Mean Change in HbA1c Levels

To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24. (NCT01031680)
Timeframe: Baseline to Week 24

Intervention	Percent (Least Squares Mean)
Experimental	-0.38
Placebo Comparator	0.08

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Adjusted Mean Percent Change in Body Weight

To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo. (NCT01031680)
Timeframe: Baseline to Week 24

Intervention	Percentage of Body Weight (Least Squares Mean)
Experimental	-2.56
Placebo Comparator	-0.30

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Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)

To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo. (NCT01031680)
Timeframe: Baseline to Week 8

Intervention	mmHg (Least Squares Mean)
Experimental	-2.96
Placebo Comparator	-0.99

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Adjusted Mean Change in HbA1c Levels

To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24. (NCT01042977)
Timeframe: Baseline to Week 24

Intervention	Percent (Least Squares Mean)
Dapagliflozin	-0.33
Placebo	0.07

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Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit

To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure. (NCT01042977)
Timeframe: Baseline to Week 24

Intervention	Percentage of participants (Number)
Dapagliflozin	10.0
Placebo	1.9

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Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²

Intervention	Percentage of participants (Least Squares Mean)
Dapagliflozin	18.4
Placebo	4.8

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Adjusted Mean Percent Change in Body Weight

To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo. (NCT01042977)
Timeframe: Baseline to Week 24

Intervention	Percentage of Body Weight (Least Squares Mean)
Dapagliflozin	-2.53
Placebo	-0.61

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Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)

To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo. (NCT01042977)
Timeframe: Baseline to Week 8

Intervention	mmHg (Least Squares Mean)
Dapagliflozin	-1.85
Placebo	0.86

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Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)

To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo. (NCT01042977)
Timeframe: Baseline to Week 24

Intervention	mmHg (Least Squares Mean)
Dapagliflozin	-2.70
Placebo	0.32

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Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg

To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8. (NCT01042977)
Timeframe: Baseline to Week 8

Intervention	mmHg (Least Squares Mean)
Dapagliflozin	-5.33
Placebo	-1.89

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Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Liquid Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PLMG measurements were obtained on Day 1 and week 24 in the double-blind period. (NCT01095653)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
Placebo	1.08
Dapagliflozin 5 mg	-46.8
Dapagliflozin 10 mg	-54.9

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period. (NCT01095653)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
Placebo	2.5
Dapagliflozin 5 mg	-25.1
Dapagliflozin 10 mg	-31.6

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

Intervention	% of hemoglobin (Mean)
Placebo	-0.29
Dapagliflozin 5 mg	-1.04
Dapagliflozin 10 mg	-1.11

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Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

Intervention	Percentage of participants (Mean)
Placebo	21.3
Dapagliflozin 5 mg	42.6
Dapagliflozin 10 mg	49.8

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Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. (NCT01095653)
Timeframe: From Baseline to Week 24

Intervention	kg (Mean)
Placebo	-0.27
Dapagliflozin 5 mg	-1.64
Dapagliflozin 10 mg	-2.25

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

Intervention	% of hemoglobin (Mean)
Placebo + Metformin	-0.23
Dapagliflozin 5 mg + Metformin	-0.82
Dapagliflozin 10 mg + Metformin	-0.85

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period. (NCT01095666)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
Placebo + Metformin	0.5
Dapagliflozin 5 mg + Metformin	-21.6
Dapagliflozin 10 mg + Metformin	-26.6

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Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. (NCT01095666)
Timeframe: From Baseline to Week 24

Intervention	kg (Mean)
Placebo + Metformin	-0.74
Dapagliflozin 5 mg + Metformin	-1.84
Dapagliflozin 10 mg + Metformin	-2.56

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Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PMG measurements were obtained on Day 1 and week 24 in the double-blind period. (NCT01095666)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
Placebo + Metformin	-15.5
Dapagliflozin 5 mg + Metformin	-57.8
Dapagliflozin 10 mg + Metformin	-64.6

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Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Percentage of participants were estimated by modified logistic regression model, adjusted for baseline HbA1c. (NCT01095666)
Timeframe: From Baseline to Week 24

Intervention	Percentage of Participants (Number)
Placebo + Metformin	17.5
Dapagliflozin 5 mg + Metformin	32.9
Dapagliflozin 10 mg + Metformin	33.0

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Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12

Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. (NCT01137474)
Timeframe: From Baseline to Week 12

Intervention	mg/dL (Mean)
Placebo	0.05
Dapagliflozin 10 mg	-0.27

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Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12

All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. (NCT01137474)
Timeframe: From Baseline to Week 12

Intervention	mm Hg (Mean)
Placebo	-4.79
Dapagliflozin 10 mg	-5.79

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Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])

Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them. (NCT01137474)
Timeframe: From Baseline to Week 12

Intervention	mm Hg (Mean)
Placebo	-5.53
Dapagliflozin 10 mg	-6.15

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Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12

HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation. (NCT01137474)
Timeframe: From Baseline to Week 12

Intervention	Percent (Mean)
Placebo	-0.10
Dapagliflozin 10 mg	-0.56

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Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)

Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them. (NCT01137474)
Timeframe: From Baseline to Week 12

Intervention	mm Hg (Mean)
Placebo	-6.73
Dapagliflozin 10 mg	-9.62

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Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12

Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation. (NCT01137474)
Timeframe: From Baseline to Week 12

Intervention	mm Hg (Mean)
Dapagliflozin 10 mg	-10.40
Placebo	-7.34

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Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants

Adjusted mean change in serum uric acid from baseline at Week 12 was calculated. Serum uric acid was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Serum uric acid measurements were obtained at qualification and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period but only the change from baseline at Week 12 was considered a secondary endpoint and is presented. (NCT01195662)
Timeframe: Baseline, Week 12

Intervention	mg/dL (Mean)
Placebo Matching Dapagliflozin	-0.03
Dapagliflozin 10 mg	-0.43

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Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue

Medical Dictionary for Regulatory Activities (MedDRA), version 15.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last double blind dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Only hypoglycemia reported as an SAE is included in AE/SAE categories . All reported hypoglycemia events within 4 days of last day of treatment are included as hypoglycemic events. (NCT01195662)
Timeframe: Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event

Intervention	participants (Number)
	Deaths	SAEs	Related SAEs	AEs	Hypoglycemia AEs	Related AEs	Discontinued due to AE	Discontinued due to SAE	Discontinued due to Hypoglycemia
Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)	0	1	0	60	2	8	2	1	0
Dapagliflozin 10 mg	0	6	0	98	13	15	1	0	0
Placebo Matching Dapagliflozin	0	2	1	93	6	12	4	1	0

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Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue

Orthostatic hypotension was defined as a decrease from supine to standing of > 20 mmHg in systolic BP or >10 mmHg in diastolic BP. Proportion was calculated from number of participants with orthostatic hypotension (n) divided by the number of treated participants (N). n/N presented as a percent (%). Baseline was Day 1 of the double blind Period. Measurements for orthostatic hypotension were taken on Day 1 and at Week 12 visit and does not reflect AEs reported by the investigator. (NCT01195662)
Timeframe: Baseline (Day 1), Week 12

Intervention	Percent of Participants (Number)
	Baseline n/N (2/220, 2/222)	Week 12 n/N (4/199, 7/203)
Dapagliflozin 10 mg	0.9	3.4
Placebo Matching Dapagliflozin	0.9	2.0

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Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue

12-Lead electrocardiograms (ECGs) were performed at Enrollment, Day 1 of Double Blind Period and Week 12/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator as normal or abnormal. Baseline (BL) was Day 1 prior to dosing or last observation prior to dosing. (NCT01195662)
Timeframe: Baseline, Week 12

Intervention	participants (Number)
	Baseline normal/Week 12 normal	Baseline normal/Week 12 abnormal	Baseline normal/ Week 12 not reported	Baseline abnormal/Week 12 normal	Baselline abnormal/Week 12 abnormal	Baseline abnormal/Week 12 not reported	Baseline not reported/Week 12 normal	Baseline not reported/Week 12 abnormal	Baseline not reported/Week 12 not reported
Dapagliflozin 10 mg	130	10	0	22	50	0	0	0	13
Placebo Matching Dapagliflozin	137	9	0	10	48	0	0	0	20

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Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue

Samples obtained: Day 1, Weeks 4, 8,12 in Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), Marked abnormality Low (High): hemoglobin <6 (>18 females or >20 males) g/dL; creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose < 54 or (> 350) mg/dL; albumin <= 2 or (> 6) g/dL; creatine kinase >5*ULN; albumin/creatinine ratio (>1800 mg/G); calcium <7.5 (>1 and >0.5 from PreRX) mg/dL; bicarbonate <=13 meq/dL; potassium <=2.5 (>6) meq/L; magnesium <1 (>4) mEq/L; sodium < 130 mEq/L (>150 mEq/L; phosphorus (>=5.6 mg/dL age 17-65, >=5.1 is >=66 years); Albumin/creatinine ratio (>1800 mg/g). Note: Hepatic tests are presented separately in next outcome measure. (NCT01195662)
Timeframe: Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days

Intervention	participants (Number)
	Hemoglobin High >18 g/dL (n=218, 223)	Creatinine >=1.5PreRx (n=218,223)	Glucose, plasma unspecif <54 mg/dL (n=218,222)	Glucose, plasma unspecif >350 mg/dL (n=218,222)	Creatine Kinase >5*ULN (n=218,223)	Creatine Kinase >10*ULN (n=218,223)	Calcium, total <7.5 mg (n=218,223)	Potassium, serum≥6 mEq/L (n=218,222)	Magnesium <1 mEq/L (n=218,223)	Sodium, serum <130 mEq/L (n=218,222)	Sodium, serum >150 mEq/L (n=218,222)	Phosphorus inorganic High (n=218,223)	Albumin/Creatinine Ratio High (n=218, 223)
Dapagliflozin 10 mg	0	3	1	1	0	0	1	4	2	0	1	2	3
Placebo Matching Dapagliflozin	1	1	0	2	2	1	0	0	0	1	1	0	5

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Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue

Laboratories were obtained at Day 1, Weeks 4, 8 and 12 in the Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Includes laboratory values measured after the first date of double-blind treatment and up to and including the last day of double blind treatment plus 30 days. Upper limit of normal (ULN);, alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality (High): AST and ALT (>3*ULN); ALP (>1.5*ULN); bilirubin (>1.5*ULN). Participants with abnormally elevated liver laboratory tests were followed 30 days after the last dose of study drug. (NCT01195662)
Timeframe: Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days

Intervention	participants (Number)
	AST >3*ULN (n=221, 224)	AST >5*ULN (n=221, 224)	AST >10*ULN (n=221, 224)	AST >20*ULN (n=221, 224)	ALT >3*ULN (n=221, 224)	ALT >5*ULN (n=221, 224)	ALT >10*ULN (n=221, 224)	ALT >20*ULN (n=221, 224)	Total Bilirubin >1.5*ULN (n=221, 224)	Total Bilirubin >2*ULN (n=221, 224)	ALP >1.5*ULN (n=221, 224)
Dapagliflozin 10 mg	3	1	1	1	3	2	1	1	2	1	4
Placebo Matching Dapagliflozin	0	0	0	0	0	0	0	0	0	0	5

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Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants

Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Blood pressure (BP) values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the BP was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured. (NCT01195662)
Timeframe: Baseline to Week 12

Intervention	mmHg (Mean)
	Week 2 (N=218, 221)	Week 4 (N=213, 220)	Week 8 (N=205, 212)	Week 12 (N=199, 205)
Dapagliflozin 10 mg	-7.93	-9.69	-11.38	-11.90
Placebo Matching Dapagliflozin	-5.13	-6.05	-6.80	-7.62

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Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants

Diastolic BP was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Diastolic BP values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the pressure was higher in one arm than the other, then this arm was used; if no difference, the participant's dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured. (NCT01195662)
Timeframe: Baseline to Week 12

Intervention	mmHg (Mean)
	Week 2 (N=218, 221)	Week 4 (N=213, 220)	Week 8 (N=205, 212)	Week 12 (N=199, 205)
Dapagliflozin 10 mg	-5.22	-5.57	-6.53	-6.30
Placebo Matching Dapagliflozin	-3.84	-4.28	-4.76	-5.33

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Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants

Adjusted mean change in glycosylated hemoglobin ( HbA1c) from baseline at Week 12 was calculated. HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period. (NCT01195662)
Timeframe: Baseline to Week 12

Intervention	Percent of Hemoglobin (Mean)
	Week 4 (N=214, 219)	Week 8 (N=207, 211)	Week 12 (N=197, 204)
Dapagliflozin 10 mg	-0.41	-0.58	-0.63
Placebo Matching Dapagliflozin	-0.06	-0.07	-0.02

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Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)

Ambulatory 24 hour (hr) BP monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF). Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained. The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site. (NCT01195662)
Timeframe: Baseline, Week 12

Intervention	mmHg (Mean)
Placebo Matching Dapagliflozin	-5.57
Dapagliflozin 10 mg	-7.56

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Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)

Ambulatory 24 hour (hr) blood pressure monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF) for analysis. Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained.The ABPM units were calibrated, and used per the manufacturer's and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site. (NCT01195662)
Timeframe: Baseline, Week 12

Intervention	mmHg (Mean)
Placebo Matching Dapagliflozin	-6.88
Dapagliflozin 10 mg	-11.33

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Adjusted Mean Change in HbA1c Levels

To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment. (NCT01217892)
Timeframe: Baseline to Week 16

Intervention	Percent (Least Squares Mean)
Dapagliflozin 2.5mg BID Plus Metformin	-0.52
Dapagliflozin 5mg BID Plus Metformin	-0.65
Dapagliflozin 10mg OD Plus Metformin	-0.59
Placebo Plus Metformin	-0.30

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Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16

To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment. (NCT01217892)
Timeframe: Baseline to Week 16

Intervention	mg/dL (Least Squares Mean)
Dapagliflozin 2.5mg BID Plus Metformin	-20.8
Dapagliflozin 5mg BID Plus Metformin	-25.6
Dapagliflozin 10mg OD Plus Metformin	-20.4
Placebo Plus Metformin	-10.4

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Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1

To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment. (NCT01217892)
Timeframe: Baseline to Week 1

Intervention	mg/dL (Least Squares Mean)
Dapagliflozin 2.5mg BID Plus Metformin	-13.7
Dapagliflozin 5mg BID Plus Metformin	-14.7
Dapagliflozin 10mg OD Plus Metformin	-15.5
Placebo Plus Metformin	2.0

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Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.

To compare the adjusted proportions controlling for baseline HbA1c [acc. to Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu] of participants with HbA1c <7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline. (NCT01217892)
Timeframe: Baseline to Week 16

Intervention	Percentage of participants (Least Squares Mean)
Dapagliflozin 2.5mg BID Plus Metformin	33.6
Dapagliflozin 5mg BID Plus Metformin	38.2
Dapagliflozin 10mg OD Plus Metformin	28.1
Placebo Plus Metformin	21.4

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Adjusted Percent Change in Body Weight

To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment. (NCT01217892)
Timeframe: Baseline to Week 16

Intervention	Percent (Least Squares Mean)
Dapagliflozin 2.5mg BID Plus Metformin	-2.84
Dapagliflozin 5mg BID Plus Metformin	-3.20
Dapagliflozin 10mg OD Plus Metformin	-2.76
Placebo Plus Metformin	-1.04

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Adjusted Mean Change in Body Weight

To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. (NCT01294423)
Timeframe: From Baseline to Week 24

Intervention	kg (Least Squares Mean)
Dapagliflozin 5 mg	-2.13
Dapagliflozin 10 mg	-2.22
Placebo	-0.84

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Adjusted Mean Change in Fasting Plasma Glucose (FPG)

To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. (NCT01294423)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Least Squares Mean)
Dapagliflozin 5 mg	-8.6
Dapagliflozin 10 mg	-13.7
Placebo	5.8

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Adjusted Mean Change in HbA1c Levels

To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. (NCT01294423)
Timeframe: From Baseline to Week 24

Intervention	Percent (Least Squares Mean)
Dapagliflozin 5 mg	-0.41
Dapagliflozin 10 mg	-0.45
Placebo	-0.06

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Mean Change in Magnesium

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L) (NCT01294436)
Timeframe: Baseline to Week 52

Intervention	mEq/L (Mean)
Monotherapy	0.05
All Combination Therapies	0.05

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Mean Change in Seated Diastolic Blood Pressure

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure (NCT01294436)
Timeframe: Baseline to Week 52

Intervention	mmHg (Mean)
Monotherapy	-2.9
All Combination Therapies	-2.1

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Mean Change in Seated Heart Rate

Intervention	beats per minute (bpm) (Mean)
Monotherapy	-0.4
All Combination Therapies	0.2

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Mean Change in Blood Urea Nitrogen (BUN)

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen (NCT01294436)
Timeframe: Baseline to Week 52

Intervention	mg/dL (Mean)
Monotherapy	2.4
All Combination Therapies	2.3

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Mean Change in Alanine Aminotransferase (ALT)

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase (NCT01294436)
Timeframe: Baseline to Week 52

Intervention	U/L (Mean)
Monotherapy	-7.1
All Combination Therapies	-5.4

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Mean Change in Body Weight

To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in body weight (NCT01294436)
Timeframe: Baseline to Week 52

Intervention	kg (Mean)
Monotherapy	-2.58
All Combination Therapies	-2.06

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Mean Change in Aspartate Aminotransferase (AST)

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase (NCT01294436)
Timeframe: Baseline to Week 52

Intervention	U/L (Mean)
Monotherapy	-3.9
All Combination Therapies	-2.6

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Mean Change in HbA1c Levels

Intervention	Percent (Mean)
Monotherapy	-0.66
All Combination Therapies	-0.68

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Mean Change in Serum Uric Acid

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid (NCT01294436)
Timeframe: Baseline to Week 52

Intervention	mg/dL (Mean)
Monotherapy	-0.61
All Combination Therapies	-0.50

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Mean Change in Seated Systolic Blood Pressure

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure (NCT01294436)
Timeframe: Baseline to Week 52

Intervention	mmHg (Mean)
Monotherapy	-5.2
All Combination Therapies	-3.9

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Mean Change in Hematocrit

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit (NCT01294436)
Timeframe: Baseline to Week 52

Intervention	Percent (Mean)
Monotherapy	2.17
All Combination Therapies	2.00

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Proportion of Participants With At Least One Episode of Hypoglycemia

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia (NCT01294436)
Timeframe: Long-term treatment up to 52 weeks

Intervention	Percentage of participants (Number)
Monotherapy	2.4
All Combination Therapies	4.0

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Proportion of Participants With Adverse Events

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events (NCT01294436)
Timeframe: Long-term treatment up to 52 weeks

Intervention	Percentage of participants (Number)
Monotherapy	79.1
All Combination Therapies	72.4

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Proportion of Participants With Serious Adverse Events

To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events (NCT01294436)
Timeframe: Long-term treatment up to 52 weeks

Intervention	Percentage of participants (Number)
Monotherapy	5.6
All Combination Therapies	3.1

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Adjusted Mean Change From Baseline in FPG

To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 24

Intervention	mg/dL (Least Squares Mean)
Placebo Plus Metformin Plus Sulfonylurea	-0.78
Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea	-34.23

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Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure

To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 8

Intervention	mmHg (Least Squares Mean)
Placebo Plus Metformin Plus Sulfonylurea	-0.27
Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea	-4.04

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Adjusted Mean Change From Baseline in HbA1c Levels

To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea. (NCT01392677)
Timeframe: Baseline to week 24

Intervention	Percent (Least Squares Mean)
Placebo Plus Metformin Plus Sulfonylurea	-0.17
Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea	-0.86

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Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)

To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 24

Intervention	Percentage of participants (Least Squares Mean)
Placebo Plus Metformin Plus Sulfonylurea	11.1
Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea	31.8

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Adjusted Mean Change From Baseline in Total Body Weight

To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo (NCT01392677)
Timeframe: Baseline to week 24

Intervention	kg (Least Squares Mean)
Placebo Plus Metformin Plus Sulfonylurea	-0.58
Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea	-2.65

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Change in Mitochondrial Function

The change in mitochondrial function/gene expression at two weeks compared to baseline. This was measured by energy expenditure. (NCT01439854)
Timeframe: baseline, two weeks

Intervention	cal/min.kg (Mean)
	Baseline Measurement	Measurement at 2 weeks
Dapagliflozin	1.3	1.34
Placebo	1.06	1.0

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Change in Insulin Sensitivity

The change in insulin sensitivity and total glucose disposal measured at two weeks with the insulin clamp compared to baseline. This is measured using TGD (whole body tissue glucose disposal)/SSPI (steady state plasma insulin concentration) ratio (NCT01439854)
Timeframe: baseline, two weeks

Intervention	mg/kg.min per µU/ml (Mean)
	Baseline Measurement	2 weeks
Dapagliflozin	3.85	5.22
Placebo	3.18	3.57

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Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)

Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations. (NCT01498185)
Timeframe: Day 7 (0 hr to 24 hr post dose)

Intervention	ng/mL (Geometric Mean)
Dapagliflozin 1 mg + Insulin	12.18
Dapagliflozin 2.5 mg + Insulin	24.19
Dapagliflozin 5 mg + Insulin	66.11
Dapagliflozin 10 mg + Insulin	134.34

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Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)

Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations. (NCT01498185)
Timeframe: Day 7 (0 hr to 24 hr post dose)

Intervention	hour (Mean)
Dapagliflozin 1 mg + Insulin	1.04
Dapagliflozin 2.5 mg + Insulin	1.08
Dapagliflozin 5 mg + Insulin	1.03
Dapagliflozin 10 mg + Insulin	1.27

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Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU]

"Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (NCT01498185)
Timeframe: Day 7 (0 hr to 24 hr post dose)

Intervention	(ngh/mL):(ngh/mL) (Geometric Mean)
Dapagliflozin 1 mg + Insulin	0.72
Dapagliflozin 2.5 mg + Insulin	0.73
Dapagliflozin 5 mg + Insulin	0.68
Dapagliflozin 10 mg + Insulin	0.66

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Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7

7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period. (NCT01498185)
Timeframe: From Baseline to Day 7

Intervention	mg/dL (Mean)
Placebo + Insulin	-16.52
Dapagliflozin 1 mg + Insulin	-19.01
Dapagliflozin 2.5 mg + Insulin	-17.29
Dapagliflozin 5 mg + Insulin	-23.40
Dapagliflozin 10 mg + Insulin	-17.55

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Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])

Intervention	ng*h/mL (Geometric Mean)
Dapagliflozin 1 mg + Insulin	49.63
Dapagliflozin 2.5 mg + Insulin	132.38
Dapagliflozin 5 mg + Insulin	262.58
Dapagliflozin 10 mg + Insulin	567.77

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Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)

Intervention	ng/mL (Geometric Mean)
Dapagliflozin 1 mg + Insulin	10.58
Dapagliflozin 2.5 mg + Insulin	21.96
Dapagliflozin 5 mg + Insulin	49.22
Dapagliflozin 10 mg + Insulin	106.68

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Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)

Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations. (NCT01498185)
Timeframe: Day 7 (0 hr to 24 hr post dose)

Intervention	hour (Mean)
Dapagliflozin 1 mg + Insulin	1.42
Dapagliflozin 2.5 mg + Insulin	1.83
Dapagliflozin 5 mg + Insulin	1.57
Dapagliflozin 10 mg + Insulin	1.84

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Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])

Intervention	ng*h/mL (Geometric Mean)
Dapagliflozin 1 mg + Insulin	48.42
Dapagliflozin 2.5 mg + Insulin	127.17
Dapagliflozin 5 mg + Insulin	269.09
Dapagliflozin 10 mg + Insulin	600.01

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Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin

Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL). (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	ng*h/mL (Geometric Mean)
Dapagliflozin 2.5 mg	101
Dapagliflozin 5 mg	199
Dapagliflozin 10 mg	427

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Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide

Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL). (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	ng*h/mL (Geometric Mean)
Dapagliflozin 2.5 mg	95.8
Dapagliflozin 5 mg	208
Dapagliflozin 10 mg	612

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Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin

Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL). (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	ng*h/mL (Geometric Mean)
Dapagliflozin 2.5 mg	92.3
Dapagliflozin 5 mg	189
Dapagliflozin 10 mg	418

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Mean Plasma Half-life (T-HALF) of Dapagliflozin

Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours. (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	hours (Mean)
Dapagliflozin 2.5 mg	14.1
Dapagliflozin 5 mg	10.3
Dapagliflozin 10 mg	10.7

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Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide

Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanograms per milliliter (ng/mL). (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	ng/mL (Geometric Mean)
Dapagliflozin 2.5 mg	24.6
Dapagliflozin 5 mg	49.0
Dapagliflozin 10 mg	154

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Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin

Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanograms per milliliter (ng/mL). (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	ng/mL (Geometric Mean)
Dapagliflozin 2.5 mg	24.8
Dapagliflozin 5 mg	48.4
Dapagliflozin 10 mg	118

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Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide

Intervention	ng*hr/mL (Geometric Mean)
Dapagliflozin 2.5 mg	105
Dapagliflozin 5 mg	232
Dapagliflozin 10 mg	658

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Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.

Participants were followed from dosing on Day 1 until study discharge on Day 3. The number of participants with investigator-assessed clinically-important abnormalities in vital sign measurements, ECGs or physical examinations was reported. (NCT01525238)
Timeframe: Day 1 to Day 3

Intervention	participants (Number)
	Vital sign abnormalities	ECG abnormalities	Physical examination abnormalities
Dapagliflozin 10 mg	0	0	0
Dapagliflozin 2.5 mg	0	0	0
Dapagliflozin 5 mg	0	0	0

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Number of Participants With Marked Urinalysis Abnormalities

LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Blood, urine (Qualitative): >=2 (If Pre-Rx >= 1, >=2*Pre-Rx). Glucose, urine (Qualitative): >=1, (If Pre-Rx >=1, >=2*Pre-Rx). Protein, urine (Qualitative): >=2 (If Pre-Rx >=1, >=2*Pre-Rx). Red Blood Cells (RBC), urine (RBC per High Power Field (hpf)): >=2 (If Pre-Rx>=2, >=4). White Blood Cells (WBC), urine (hpf): >=2 (If Pre-Rx>=2, >=4). (NCT01525238)
Timeframe: Day 1 (Pre-dose) to Day 3

Intervention	participants (Number)
	Blood, urine, high (n=8, 8, 8)	Glucose, urine, high (n=8, 8, 8)	Protein, urine, high (n=8, 8, 8)	RBC, urine, high (n=1, 1, 4)	WBC, urine, high (n=4, 2, 3)
Dapagliflozin 10 mg	2	4	3	3	1
Dapagliflozin 2.5 mg	0	2	0	0	1
Dapagliflozin 5 mg	0	3	0	0	0

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Number of Participants With Marked Hematology Laboratory Abnormalities

LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose (Day -1). Lab values that met the following criteria were marked as abnormalities: Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (x10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx1.2*ULN (if Pre-RxULN, if Pre- Rx>ULN, use >1.15*Pre-Rx or 7.5. Monocytes (Absolute) (x10^3 c/uL): >2.000. Basophils (x10^3 c/uL): >0.4. Eosinophils (Absolute) (x10^3 c/uL): >0.75. Blasts (Absolute) (x10^9 c/L) > 0. (NCT01525238)
Timeframe: Day 1 (Pre-dose) to Day 3

Intervention	participants (Number)
	Leukocytes, low (n=8, 8, 8)	Neutrophils, low (n=8, 8, 8)
Dapagliflozin 10 mg	1	1
Dapagliflozin 2.5 mg	1	0
Dapagliflozin 5 mg	0	0

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Number of Participants With Marked Abnormalities in Other Chemistry Testing

LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Glucose, fasting serum (mmol/L): <0.8*LLN, >1.3*ULN (if Pre-RxULN. If Pre-Rx>ULN: >2.0*Pre-Rx, 1.1*ULN (if Pre-RxULN. If Pre-Rx>ULN: >1.1*Pre-Rx, 1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx). Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx) (NCT01525238)
Timeframe: Day 1 (Pre-dose) to Day 3

Intervention	participants (Number)
	Glucose, fasting serum, high (n=7, 7, 7)	Additional other chemistry marked abnormalities
Dapagliflozin 10 mg	0	0
Dapagliflozin 2.5 mg	1	0
Dapagliflozin 5 mg	1	0

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Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting

Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Means are reported in milligrams per deciliter (mg/dL). (NCT01525238)
Timeframe: Day 1 (Pre-dose) to Day 2

Intervention	mg/dL (Mean)
	Day 1 Pre-dose (n= 6, 8, 8)	Day 2 after 8 hour fast (n= 3, 8, 7)
Dapagliflozin 10 mg	139.8	119.0
Dapagliflozin 2.5 mg	146.2	124.0
Dapagliflozin 5 mg	152.1	119.4

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Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide

Time of maximum observed plasma concentration (Tmax) for Dapagliflozin 3-O-Glucuronide was derived from plasma concentrations versus time data. Medians were reported in hours (h). (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	hours (Median)
Dapagliflozin 2.5 mg	1.50
Dapagliflozin 5 mg	1.50
Dapagliflozin 10 mg	1.50

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Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin

Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h). (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	hours (Median)
Dapagliflozin 2.5 mg	1.50
Dapagliflozin 5 mg	0.960
Dapagliflozin 10 mg	0.875

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Mean Total Amount of Glucose Excreted in Urine Over 24 Hours

The total amount of glucose excreted in urine was measured for 24 hours following administration of Dapagliflozin. Means are reported in grams. (NCT01525238)
Timeframe: Time of dose to 24 hours post-dose, Day 1 to Day 2

Intervention	grams (Mean)
Dapagliflozin 2.5 mg	52.84
Dapagliflozin 5 mg	62.39
Dapagliflozin 10 mg	89.04

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Mean Change in Fasting Plasma Glucose From Baseline Until Day 2

Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Mean change from baseline to Day 2 is reported in milligrams per deciliter (mg/dL). (NCT01525238)
Timeframe: Day 1 (Pre-dose) to Day 2

Intervention	mg/dL (Mean)
Dapagliflozin 2.5 mg	-46.7
Dapagliflozin 5 mg	-32.8
Dapagliflozin 10 mg	-22.0

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Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide

Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentration versus time data. Means are reported in hours. (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	hours (Mean)
Dapagliflozin 2.5 mg	4.62
Dapagliflozin 5 mg	8.71
Dapagliflozin 10 mg	8.37

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Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin

Apparent clearance after extravascular administration (CL/F) of Dapagliflozin was derived from plasma concentrations versus time data. Geometric means are reported in milliliters per minute (mL/min). (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	mL/min (Geometric Mean)
Dapagliflozin 2.5 mg	413
Dapagliflozin 5 mg	418
Dapagliflozin 10 mg	391

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Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin

Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L) (NCT01525238)
Timeframe: 11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose

Intervention	Liters (Geometric Mean)
Dapagliflozin 2.5 mg	468
Dapagliflozin 5 mg	343
Dapagliflozin 10 mg	355

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Number of Participants With Marked Serum Chemistry Abnormalities

LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): >1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (micromoles per Liter (umol/L)): >1.5*ULN if Pre-Rx missing or <= ULN, >1.33*Pre-Rx if PreRx > ULN. Sodium (mmol/L): >1.05*ULN, 1.05*Pre-Rx if Pre-Rx>ULN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, 1.1*ULN (if Pre-RxULN. If Pre-Rx>ULN: >1.1*Pre-Rx, 1.25*ULN (if Pre-RxULN. if Pre-Rx>ULN: >1.25*Pre-Rx, NCT01525238)
Timeframe: Day 1 (Pre-dose) to Day 3

Intervention	participants (Number)
	ALT, high (8, 8, 8)	AST, high (n=8, 8, 8)
Dapagliflozin 10 mg	0	0
Dapagliflozin 2.5 mg	1	1
Dapagliflozin 5 mg	0	0

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Adjusted Mean Change From Baseline in Body Weight at Week 24

Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24

Intervention	Body weight Kg (Mean)
Arm 1: Saxagliptin+Metformin XR+Placebo	0.00
Arm 2: Dapagliflozin+Metformin XR+Placebo	-2.39
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR	-2.05

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24

Intervention	mg/dL (Mean)
Arm 1: Saxagliptin+Metformin XR+Placebo	-14.0
Arm 2: Dapagliflozin+Metformin XR+Placebo	-31.7
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR	-37.8

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Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT01606007)
Timeframe: At Week 24

Intervention	% of Participants (Number)
Arm 1: Saxagliptin+Metformin XR+Placebo	18.3
Arm 2: Dapagliflozin+Metformin XR+Placebo	22.2
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR	41.4

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24

HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24

Intervention	% HbA1c (Mean)
Arm 1: Saxagliptin+Metformin XR+Placebo	-0.88
Arm 2: Dapagliflozin+Metformin XR+Placebo	-1.20
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR	-1.47

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Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])

Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue. (NCT01606007)
Timeframe: Baseline (Week 0) and at Week 24

Intervention	MG/DL PPG (Mean)
Arm 1: Saxagliptin+Metformin XR+Placebo	-35.6
Arm 2: Dapagliflozin+Metformin XR+Placebo	-70.4
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR	-79.6

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24

Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue. (NCT01619059)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
Saxagliptin 5mg + Dapagliflozin 10mg + Metformin	-9.1
Placebo + Dapagliflozin 10mg + Metformin	-5.3

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Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24

Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue. (NCT01619059)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Mean)
Saxagliptin 5mg + Dapagliflozin 10mg + Metformin	-37.1
Placebo + Dapagliflozin 10mg + Metformin	-31.3

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24

Intervention	Percent of glycosylated haemoglobin (Mean)
Saxagliptin 5mg + Dapagliflozin 10mg + Metformin	-0.51
Placebo + Dapagliflozin 10mg + Metformin	-0.16

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Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. (NCT01619059)
Timeframe: From Baseline to Week 24

Intervention	Percent of participants (Number)
Saxagliptin 5mg + Dapagliflozin 10mg + Metformin	35.3
Placebo + Dapagliflozin 10mg + Metformin	23.1

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Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. (NCT01646320)
Timeframe: From baseline to week 24

Intervention	Percentage of subjects (Number)
Dapa+Saxa+Met	36.7
Pla+Saxa+Met	13.3

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Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period. (NCT01646320)
Timeframe: From Baseline to Week 24

Intervention	Percentage of glycosylated hemoglobin (Least Squares Mean)
Dapa+Saxa+Met	-0.82
Pla+Saxa+Met	-0.1

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24

Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period (NCT01646320)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Least Squares Mean)
Dapa+Saxa+Met	-32.7
Pla+Saxa+Met	-5.3

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Adjusted Mean Change From Baseline in Body Weight at Week 24

Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period. (NCT01646320)
Timeframe: From baseline to Week 24

Intervention	kg (Least Squares Mean)
Dapa+Saxa+Met	-1.91
Pla+Saxa+Met	-0.41

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Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24

2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT. (NCT01646320)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Least Squares Mean)
Dapa+Saxa+Met	-73.5
Pla+Saxa+Met	-38.0

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Plasma Apparent Clearance (CLT/F) of a Single Dose of Dapagliflozin Versus CLT/F of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population

Intervention	mL/min (Geometric Mean)
10 mg Dapagliflozin	305
5 mg Saxagliptin + 10 mg Dapagliflozin	309

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Mean Change From Baseline in Temperature - Safety Population

Participant had their temperature taken after quietly sitting for at least 5 minutes and it was measured as degrees of centigrade (C). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. (NCT01662999)
Timeframe: Baseline to Day 1 in each period

Intervention	degrees of centigrade (Mean)
Treatment A: Saxagliptin 5mg	-0.15
Treatment B: Dapagliflozin 10mg	-0.23
Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg	-0.16

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Mean Change From Baseline in Respiration Rate - Safety Population

Respiration rates were taken while the participant was sitting quietly for at least 5 minutes and were measured in breaths per minute (bpm). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. (NCT01662999)
Timeframe: Baseline to Day 1 in each period

Intervention	bpm (Mean)
Treatment A: Saxagliptin 5mg	-0.4
Treatment B: Dapagliflozin 10mg	-1.2
Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg	-0.9

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Mean Change From Baseline in Heart Rate - Safety Population

Heart rates were taken while the participant was sitting quietly for at least 5 minutes and were measured in beats per minute (bpm). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. (NCT01662999)
Timeframe: Baseline to Day 1 in each period

Intervention	bpm (Mean)
Treatment A: Saxagliptin 5mg	-4.4
Treatment B: Dapagliflozin 10mg	-4.0
Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg	-4.3

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Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin From a Single Dose of Dapagliflozin Versus Cmax of Dapagliflozin From Co-administered Saxagliptin Plus Dapagliflozin - Pharmacokinetic Evaluable Population

The geometric mean of the maximum observed plasma concentration (Cmax) is presented below; serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h,and 60 h postdose, relative to dosing on Day 1 in each cross over period and these data are summarized in the Pharmacokinetic (PK) parameter of Cmax presented here. Plasma samples were analyzed for dapagliflozin by High Performance Liquid chromatography-Mass Spectrometry (HPLC-MS/MS) using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Dapagliflozin Cmax was derived from plasma concentration versus time data using a non-compartmental method, using a validated PK analysis program ™. Actual sampling times were used for PK calculations. Cmax was reported in ng/mL. (NCT01662999)
Timeframe: Day 1 (0 h to 60 h post dose) in each period

Intervention	ng/mL (Geometric Mean)
10 mg Dapagliflozin	133
5 mg Saxagliptin + 10 mg Dapagliflozin	125

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Maximum Observed Concentration (Cmax) of a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population

Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography-Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). Cmax for Saxagliptin was derived from plasma concentration versus time data using a validated PK analysis program ™ and was measured in nanograms per milliliter (ng/mL). (NCT01662999)
Timeframe: Day 1 (0h to 60h post dose) in each period

Intervention	ng/mL (Geometric Mean)
5 mg Saxagliptin	23.6
5 mg Saxagliptin + 10 mg Dapagliflozin	21.9

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Half-life (T-HALF) of Dapagliflozin From a Single Dose of Dapagliflozin Versus T-Half of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population

Intervention	hours (Mean)
10mg Dapagliflozin	15.9
5 mg Saxagliptin + 10 mg Dapagliflozin	13.8

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Cmax of the Saxagliptin Total Active Moiety From a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population

Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Cmax of saxagliptin total active moiety (molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin) was derived from the plasma concentration versus time profile for the saxagliptin total active moiety. Measurement was in nano Molars (nM). (NCT01662999)
Timeframe: Day 1 (0h to 60h post dose) in each period

Intervention	nM (Geometric Mean)
5 mg Saxagliptin	138
5 mg Saxagliptin + 10 mg Dapagliflozin	137

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Cmax of 5-Hydroxy (5-OH) Saxagliptin From a Single Dose Saxagliptin Versus Cmax of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population

Intervention	ng/mL (Geometric Mean)
10 mg Dapagliflozin	47.0
5 mg Saxagliptin + 10 mg Dapagliflozin	49.6

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AUC(INF) of Saxagliptin From a Single Dose of 5 mg Saxagliptin Versus AUC(INF) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population

Intervention	ng*h/mL (Geometric Mean)
5 mg Saxagliptin	89.0
5 mg Saxagliptin + 10 mg Dapagliflozin	88.2

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AUC(INF) of 5-OH Saxagliptin From a Single Dose Saxagliptin Versus AUC(INF) of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population

Intervention	ng*h/mL (Geometric Mean)
10 mg Dapagliflozin	273
5 mg Saxagliptin + 10 mg Dapagliflozin	296

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AUC(0-T) of Saxagliptin From Single Dose 5 mg Saxagliptin Versus AUC(0-T) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population

Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography-Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(0-T), the area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL). (NCT01662999)
Timeframe: Day 1 (0h to 60h post dose) in each period

Intervention	ng*h/mL (Geometric Mean)
5 mg Saxagliptin	87.8
5 mg Saxagliptin + 10 mg Dapagliflozin	87.0

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AUC(0-T) of 5-OH Saxagliptin From Single Dose Saxagliptin Versus AUC(0-T) of 5-OH From Saxagliptin Co-administered With Dapagliflozin - PK Evaluable Population

Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method)and was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™. AUC (0-T) was measured in nanograms*hours per milliliter (ng*h/mL). (NCT01662999)
Timeframe: Day 1 (0h to 60h post dose) in each period

Intervention	ng*h/mL (Geometric Mean)
10 mg Dapagliflozin	267
5 mg Saxagliptin + 10 mg Dapagliflozin	289

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Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus AUC(0-T) for Dapagliflozin When Co-administered With 5 mg Saxagliptin

AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method). Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(0-T) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL). (NCT01662999)
Timeframe: Day 1 (0h to 60h post dose) in each period

Intervention	ng*h/mL (Geometric Mean)
10 mg Dapagliflozin	529
5 mg Saxagliptin + 10 mg Dapagliflozin	523

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Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity [AUC(INF)] of Dapagliflozin From a Single Dose of Dapagliflozin Versus AUC (INF) of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population

AUC(INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. Serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(INF) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL). (NCT01662999)
Timeframe: Day 1 (0h to 60h post dose) in each period

Intervention	ng*h/mL (Geometric Mean)
10 mg Dapagliflozin	547
5 mg Saxagliptin + 10 mg Dapagliflozin	539

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Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus Tmax of Dapagliflozin When Co-administered With 5 mg Saxagliptin - PK Evaluable Population

Intervention	hours (Median)
10 mg Dapagliflozin	1.00
5 mg Saxagliptin + 10 mg Dapagliflozin	1.00

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AUC(INF) and AUC(0-T) of the Saxagliptin Total Active Moiety From a Single Dose 5 mg Saxagliptin Versus AUC(INF) and AUC(0-T) of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population

Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method. AUC(INF) is area under the plasma concentration-time curve from time zero extrapolated to infinity; AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) and both were derived from the plasma concentration versus time profile using a validated PK analysis program ™. Total moiety (molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin), AUC(0-T)and AUC(INF) were measured in nano Molars*hours (nM*h). (NCT01662999)
Timeframe: Day 1 (0h to 60h post dose) in each period

Intervention	nM*h (Geometric Mean)
	AUC(INF) for Saxagliptin Total Active Moiety	AUC(0-T) for Saxagliptin Total Active Moiety
5 mg Saxagliptin	702	694
5 mg Saxagliptin + 10 mg Dapagliflozin	735	727

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Tmax of Saxagliptin, 5-OH Saxagliptin, Saxagliptin Total Active Moiety From a Single Dose of Saxagliptin Versus Tmax of Saxagliptin, 5-OH, Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population

Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin and 5-OH by LC-MS/MS using a validated method. Tmax was derived from the plasma concentration versus time profile for study drug and was measured in hours (h). Saxagliptin was the drug, 5-OH saxagliptin was the metabolite, and Saxagliptin total Active Moiety was molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin. (NCT01662999)
Timeframe: Day 1 (0h to 60h post dose) in each period

Intervention	h (Median)
	Tmax of Saxagliptin	Tmax of 5-OH Saxagliptin	Tmax of Saxagliptin Total Active Moiety
5 mg Saxagliptin	0.50	1.50	1.00
5 mg Saxagliptin + 10 mg Dapagliflozin	1.00	1.50	1.00

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Number of Participants With Marked Urinalysis Laboratory Abnormalities - Safety Population

Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Fasted for 10 hours prior to samples taken. LLN=lower limit of normal; ULN=upper limit of normal; pretreatment (Pre-Rx). Normals: Urine glucose qualitative: dipstick >=1 if Pre-Rx <1 or 2*Pre-Rx if Pre-Rx>=1; urine microscopic white blood cell count (WBC): >=2 if Pre-Rx <2 or >=4 if Pre-Rx >=2;urine red blood cell count (RBC):>=2 if Pre-Rx <2 or >=4 if Pre-Rx >=2. (NCT01662999)
Timeframe: Baseline to Day 1 of each period

Intervention	participants (Number)
	Urine Glucose High (N=42, 42, 42)	Urine WBC and RBC High (N= 4, 8, 6)
Treatment A: Saxagliptin 5mg	0	0
Treatment B: Dapagliflozin 10mg	2	0
Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg	5	1

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Number of Participants With Marked Hematology Laboratory Abnormalities - Safety Population

Fasted for 10 hours prior to samples taken. Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Lower limit of normal (LLN); upper limit of normal (ULN); pretreatment(pre-RX); treatment (RX). Hemoglobin (g/L): <0.85* pre-RX; hematocrit (vol): <0.85*pre-RX; erythrocytes (*10^12 c/L): <0.85*pre-RX; platelet count (*10^9 c/L): <0.85*LLN if pre-RX>=LLN, or if Pre-Tx =1.5; eosinophils (*10^9 c/L): if value >0.75; basophils (*10^9 c/L): if value >0.4; monocytes (*10^9c/L): if value >2; lymphocytes (*10^9 c/L): if value <0.750 or if value >7.50. (NCT01662999)
Timeframe: Baseline to Day 1 of each period

Intervention	participants (Number)
	Leukocytes Low	Neutrophils (absolute) Low
Treatment A: Saxagliptin 5mg	0	1
Treatment B: Dapagliflozin 10mg	0	1
Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg	1	1

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Number of Participants With Marked Chemistry Laboratory Abnormalities - Safety Population

Fasted for 10 hours prior to samples taken. Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Lower limit of normal(LLN); upper limit of normal (ULN); pre-treatment(Pre-Rx). Alkaline phosphatase U/L:>1.25*Pre-RX if Pre-Rx >ULN or >1.25*ULN if Pre-Rx <=ULN; aspartate aminotransferase (AST) U/L: >1.25*Pre-Rx if Pre-Rx > ULN or 1.25*ULN if Pre-Rx <= ULN;alanine aminotransferase (ALT) U/L: >1.25*Pre-Rx if Pre-Rx>ULN or 1.25*ULN if Pre-Rx<=ULN;blood urea nitrogen (BUN)mmol/L: >1.1*ULN if Pre-Rx <=ULN or >1.2*Pre-Rx if Pre-Rx >ULN; total bilirubin µmol/L: >1.1*ULN if Pre-Rx <=ULN or >1.25*Pre-Rx if Pre-Rx >ULN;direct bilirubin µmol/L: >1.1*ULN if Pre-Rx <= ULN or >1.25*Pre-Rx if Pre-Rx > ULN; creatine phosphokinase (CK) U/L: >1.5*Pre-Rx if Pre-Rx >ULN or >1.5*ULN if Pre-Rx <= ULN. (NCT01662999)
Timeframe: Baseline to Day 1 in each period

Intervention	participants (Number)
	Total Bilirubin High	Direct Bilirubin High	ALT High	BUN High	CK High
Treatment A: Saxagliptin 5mg	1	1	1	1	0
Treatment B: Dapagliflozin 10mg	1	1	0	0	0
Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg	1	1	1	0	1

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Number of Participants With Deaths, Serious Adverse Events, Adverse Events, or Discontinuations Due to Adverse Events - Safety Population

Adverse event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE)=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. End of study was approximately 16 days and was the time for a participant to conclude each of the 3 periods (including the 6 day washout between periods). (NCT01662999)
Timeframe: Day 1 to end of study (16 days)

Intervention	participants (Number)
	Participants with AEs	Participants with treatment-related AEs	Participants with SAEs	Participants discontinuing due to AEs	Deaths
Treatment A: Saxagliptin 5mg	6	4	0	0	0
Treatment B: Dapagliflozin 10mg	9	4	0	0	0
Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg	8	7	0	0	0

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Number of Participants With Change From Baseline in ECG Interval - Safety Population

A 12-Lead electrocardiogram (ECG) was performed and recorded after the participant had been supine for at least 5 minutes. ECGs done at baseline (Day-1 of Period 1) and at end of study; therefore the results are presented by sequence, and cannot be presented by treatment. QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). Abnormality criteria: QT/QTcF QT or QTcF >450 msec and <=480 msec at any postdose time point and not present at baseline. QT or QTcF >480 msec and <=500 msec at any postdose time point and not present at baseline QT or QTcF >500 msec at any postdose time point and not present at baseline. QT/QTcF Increase from baseline >60 msec for at least 1 postdose measurement. Increase from baseline in QT or QTcF >30 msec for at least 1 postdose measurement, but <=60 msec for all postdose measurements. (NCT01662999)
Timeframe: Baseline to end of study (16 days)

,,,,,

Intervention	participants (Number)
	QT change from baseline >60 msec	QT change from baseline >30 msec; <=60 msec	QTcF change from baseline >60 msec	QTcF change from baseline >30 msec; <=60 msec
A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)	0	0	0	0
A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin	0	4	0	0
B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)	0	0	0	0
B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin	1	0	0	0
C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin	0	0	0	0
C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin	0	0	0	0

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Metabolite to Parent Molar Ratios (MR) of Cmax, AUC(INF), and AUC(0-T) of 5-OH Saxagliptin and Saxagliptin From a Single Dose 5 mg Saxagliptin Versus MR of Saxagliptin and 5-OH When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable

Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Saxagliptin is the parent drug and 5-OH saxagliptin is the metabolite. The molecular weights to be used for the molar ratios were 315.42 and 331.42 for saxagliptin and 5-OH, respectively. Plasma samples were analyzed for saxagliptin and for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL and 0.200 ng/mL to 100.0 ng/mL for saxagliptin and 5-OH, respectively). (NCT01662999)
Timeframe: Day 1 (0h to 60h post dose) in each period

Intervention	Molar ratio (Geometric Mean)
	MR_Cmax	MR_AUC(INF)	MR_AUC(0-T)
5 mg Saxagliptin	1.90	2.92	2.89
5 mg Saxagliptin + 10 mg Dapagliflozin	2.16	3.19	3.16

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Mean Change From Baseline in Systolic and Diastolic Blood Pressure - Safety Population

Blood pressure was taken while the participant was quietly seated for at least 5 minutes. Blood pressure was measured in millimeters of mercury (mmHg). Baseline was Day -1 in Period 1; study drug was administered on Day 1 of each crossover period. (NCT01662999)
Timeframe: Baseline to Day 1 of each period

Intervention	mmHg (Mean)
	Systolic Blood Pressure	Diastolic Blood Pressure
Treatment A: Saxagliptin 5mg	-6.0	-2.6
Treatment B: Dapagliflozin 10mg	-4.6	-2.0
Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg	-7.2	-3.3

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Half-life (T-HALF) of Saxagliptin, and 5-OH Saxagliptin From Single Dose 5 mg Saxagliptin Versus T-HALF of Saxagliptin and 5-OH From Co-administered Saxagliptin With 10 mg Dapagliflozin - PK Evaluable Population

Intervention	h (Mean)
	T-HALF for Saxagliptin	T-HALF for 5-OH Saxagliptin
5 mg Saxagliptin	5.86	15.9
5 mg Saxagliptin + 10 mg Dapagliflozin	5.38	17.0

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Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24

The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU). (NCT02096705)
Timeframe: Baseline (Day 1) and 24 weeks

Intervention	International Units (IU) (Mean)
Placebo	0.74
Dapagliflozin	-0.70

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Adjusted Mean Change in Body Weight From Baseline to Week 24

Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg). (NCT02096705)
Timeframe: Baseline (Day 1) and 24 weeks

Intervention	kilograms (Mean)
Placebo	0.37
Dapagliflozin	-1.00

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Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24

The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL). (NCT02096705)
Timeframe: Baseline (Day 1) and 24 weeks

Intervention	mg/dL (Mean)
Placebo	0.07
Dapagliflozin	-30.62

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Adjusted Mean Change in HbA1c From Baseline to Week 24

The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm. (NCT02096705)
Timeframe: Baseline (Day 1) and 24 weeks

Intervention	percentage of hemoglobin (Mean)
Placebo	0.03
Dapagliflozin	-0.87

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Alanine Aminotransferase (ALT) at Week 12.

The ALT hepatic transaminase levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12.

Intervention	U/L (Mean)
Dapagliflozin	32.1
Placebo	38.1

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Waist Circumference at Week 12.

The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques. (NCT02113241)
Timeframe: Week 12

Intervention	centimeters (Mean)
Dapagliflozin	97.6
Placebo	97.2

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Glucose at Minute 90 at Week 12.

The glucose at minute 90 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12

Intervention	mmol/L (Mean)
Dapagliflozin	9.8
Placebo	9.9

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Triglycerides Levels at Week 12.

The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques. (NCT02113241)
Timeframe: Week 12

Intervention	mmol/L (Mean)
Dapagliflozin	1.7
Placebo	1.7

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Insulinogenic Index (Total Insulin Secretion) at Week 12.

"The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.~Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12." (NCT02113241)
Timeframe: Week 12

Intervention	index (Mean)
Dapagliflozin	0.35
Placebo	0.99

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Fat Mass at Week 12.

The fat mass is going to be evaluated at week 12 through bioimpedance. (NCT02113241)
Timeframe: Week 12

Intervention	kilograms (Mean)
Dapagliflozin	32.7
Placebo	34.4

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Glucose at Minute 120 at Week 12.

The glucose at minute 120 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12

Intervention	mmol/L (Mean)
Dapagliflozin	8.5
Placebo	8.8

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Glucose Levels at Minute 0 at Week 12.

The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. (NCT02113241)
Timeframe: Week 12

Intervention	mmol/L (Mean)
Dapagliflozin	5.7
Placebo	5.8

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Glucose at Minute 30 at Week 12.

The glucose at minute 30 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12

Intervention	mmol/L (Mean)
Dapagliflozin	10.5
Placebo	10.0

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Glucose at Minute 60 at Week 12.

The glucose at minute 60 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve (NCT02113241)
Timeframe: Week 12

Intervention	mmol/L (Mean)
Dapagliflozin	11.1
Placebo	11.4

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AUC of Insulin at Week 12.

The AUC will be calculated from the insulin values obtained from the minuted oral glucose tolerance curve at week 12 (NCT02113241)
Timeframe: Week 12

Intervention	pmol*h/L (Mean)
Dapagliflozin	45016
Placebo	119704

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AUC of Glucose at Week 12.

The AUC of glucose will be calculated from the glucose values obtained from the minuted oral glucose tolerance curve at week 12 (NCT02113241)
Timeframe: Week 12

Intervention	mmol*hr/L (Mean)
Dapagliflozin	1153
Placebo	1129

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Low Density Lipoproteins (c-LDL) at Week 12

The c-LDL levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12

Intervention	mmol/L (Mean)
Dapagliflozin	3.1
Placebo	2.8

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Aspartate Aminotransferase (AST) at Week 12.

The hepatic transaminase AST will be evaluated with standardized methods at week 12 (NCT02113241)
Timeframe: Week 12

Intervention	U/L (Mean)
Dapagliflozin	31.1
Placebo	29.5

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High Density Lipoprotein (c-HDL) Levels at Week 12.

The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. (NCT02113241)
Timeframe: Week 12

Intervention	mmol/L (Mean)
Dapagliflozin	1.3
Placebo	1.3

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Matsuda Index (Total Insulin Sensitivity) at Week 12.

Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity at week 12. (NCT02113241)
Timeframe: Week 12

Intervention	index (Mean)
Dapagliflozin	2.7
Placebo	1.6

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Stumvoll Index (First Phase of Insulin Secretion) at Week 12.

"Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.~First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12." (NCT02113241)
Timeframe: Week 12

Intervention	index (Mean)
Dapagliflozin	1463
Placebo	2198

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Systolic Blood Pressure at Week 12.

The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. (NCT02113241)
Timeframe: Week 12

Intervention	mmHg (Mean)
Dapagliflozin	117
Placebo	121

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Total Cholesterol at Week 12

The total cholesterol will be estimated by standardized techniques at week 12. (NCT02113241)
Timeframe: Week 12

Intervention	mmol/L (Mean)
Dapagliflozin	5.2
Placebo	4.9

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Body Weight at Week 12.

The weight it's going to be measured at week 12 with a bioimpedance balance. (NCT02113241)
Timeframe: Week 12

Intervention	kilograms (Mean)
Dapagliflozin	81.2
Placebo	79.6

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Creatinine at Week 12.

The creatinine levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12.

Intervention	mmol/L (Mean)
Dapagliflozin	0.07
Placebo	0.05

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Diastolic Blood Pressure at Week 12.

The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. (NCT02113241)
Timeframe: Week 12

Intervention	mmHg (Mean)
Dapagliflozin	76
Placebo	79

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Body Mass Index at Week 12

The Body Mass index it's going to be calculated at week 12 with the Quetelet index. (NCT02113241)
Timeframe: Week 12

Intervention	kg/m^2 (Mean)
Dapagliflozin	32.6
Placebo	32.1

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Uric Acid at Week 12.

The uric acid levels are going to be measured at week 12 with standardized techniques. (NCT02113241)
Timeframe: Week 12.

Intervention	umol/L (Mean)
Dapagliflozin	243.9
Placebo	339.0

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Total Body Weight

Mean change in total body weight from baseline to Week 16 between dapagliflozin 5 mg versus placebo (NCT02157298)
Timeframe: Baseline to Week 16

Intervention	kg (Least Squares Mean)
Dapagliflozin	-0.6
Placebo	0.7

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Total Mean Daily Insulin Dose

Mean change in calculated mean daily insulin dose from baseline to Week 16 between dapagliflozin 5 mg versus placebo (NCT02157298)
Timeframe: Baseline to Week 16

Intervention	IU/Day (Least Squares Mean)
Dapagliflozin	-0.74
Placebo	-0.02

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Proportion of Participants With Mean Daily Insulin Dose Reduction of Greater Than or Equal 10%

Proportion of participants with mean daily insulin dose reduction greater than or equal 10% from baseline to week 16 (LOCF) between dapagliflozin 5 mg versus placebo (NCT02157298)
Timeframe: Baseline to Week 16

Intervention	percentage of participants (Least Squares Mean)
Dapagliflozin	8.2
Placebo	4.9

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Adjusted Mean Change in HbA1c Levels

Mean change in HbA1c levels from baseline to Week 16 between dapagliflozin 5 mg versus placebo (NCT02157298)
Timeframe: Baseline to Week 16

Intervention	percentage of hemoglobin glycosylated (Least Squares Mean)
Dapagliflozin	-0.55
Placebo	0.05

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Fasting Plasma Glucose

Mean change in fasting plasma glucose from baseline to Week 16 between dapagliflozin 5 mg versus placebo (NCT02157298)
Timeframe: Baseline to Week 16

Intervention	mg/dL (Least Squares Mean)
Dapagliflozin	-21.7
Placebo	1.0

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Dapagliflozin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])

5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state (NCT02223065)
Timeframe: Day 1-3 (Period 1) and Day 8-10 (Period 2)

Intervention	ng.h/mL (Geometric Mean)
Treatment A	553
Treatment B	561

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Dapagliflozin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])

5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state (NCT02223065)
Timeframe: Day 1-3 (Period 1) and Day 8-10 (Period 2)

Intervention	ng.h/mL (Geometric Mean)
Treatment A	537
Treatment B	546

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Dapagliflozin Maximum Observed Concentrations (Cmax)

5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state (NCT02223065)
Timeframe: Day 1 to 3 (Period 1) and Day 8 to 10 (Period 2)

Intervention	ng/mL (Geometric Mean)
Treatment A	142
Treatment B	141

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Saxagliptin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])

5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state (NCT02223065)
Timeframe: Day 1-3 (Period 1) and Day 8-10 (Period 2)

Intervention	ng.h/mL (Geometric Mean)
Treatment A	97.0
Treatment B	99.4

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Saxagliptin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])

5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state (NCT02223065)
Timeframe: Day 1-3 (Period 1) and Day 8-10 (Period 2)

Intervention	ng.h/mL (Geometric Mean)
Treatment A	95.9
Treatment B	98.0

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Saxagliptin Maximum Observed Concentrations (Cmax)

5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state (NCT02223065)
Timeframe: Day 1-3 (Period 1) and Day 8-10 (Period 2)

Intervention	ng/mL (Geometric Mean)
Treatment A	26.2
Treatment B	25.5

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Change in Body Weight From Baseline to Week 28

To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28

Intervention	kilogram (Least Squares Mean)
Dapagliflozin + Placebo	-2.22
Exenatide + Dapagliflozin	-3.55
Exenatide + Placebo	-1.56

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Change in Fasting Plasma Glucose From Baseline to Week 2

To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 2

Intervention	mg/dL (Least Squares Mean)
Dapagliflozin + Placebo	-26.31
Exenatide + Dapagliflozin	-41.34
Exenatide + Placebo	-21.08

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Change in Fasting Plasma Glucose From Baseline to Week 28

To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28

Intervention	milligrams/deciliter (mg/dL) (Least Squares Mean)
Dapagliflozin + Placebo	-49.19
Exenatide + Dapagliflozin	-65.83
Exenatide + Placebo	-45.75

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Change in HbA1c From Baseline to Week 28

To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28

Intervention	% HbA1c (Least Squares Mean)
Dapagliflozin + Placebo	-1.39
Exenatide + Dapagliflozin	-1.98
Exenatide + Placebo	-1.60

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Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test

To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28

Intervention	mg/dL (Least Squares Mean)
Dapagliflozin + Placebo	-61.05
Exenatide + Dapagliflozin	-87.83
Exenatide + Placebo	-60.09

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Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28

To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28

Intervention	% of patients (Number)
Dapagliflozin + Placebo	20.0
Exenatide + Dapagliflozin	33.3
Exenatide + Placebo	13.7

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Percentage of Patients Achieving HbA1c <7% at Week 28

To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28

Intervention	% of patients (Number)
Dapagliflozin + Placebo	19.1
Exenatide + Dapagliflozin	44.7
Exenatide + Placebo	26.9

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Change in Systolic Blood Pressure From Baseline to Week 28

To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone. (NCT02229396)
Timeframe: Baseline to Week 28

Intervention	millimeters of mercury (mmHg) (Least Squares Mean)
Dapagliflozin + Placebo	-1.8
Exenatide + Dapagliflozin	-4.3
Exenatide + Placebo	-1.2

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Left Ventricular Mass (LVM)

LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24 (NCT02235298)
Timeframe: At Baseline, Week 12 and Week 24

Intervention	g/m^2 (Mean)
	Baseline	Week 12	Week 24
Dapagliflozin and Metformin Group	129	127	122
Metformin and Placebo Group	130	128	122

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Epicardial Fat Thickness

Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks (NCT02235298)
Timeframe: At Baseline, 12 weeks, 24 weeks

Intervention	mm (Mean)
	Baseline	12 Weeks	24 Weeks
Dapagliflozin and Metformin Group	8.6	7.2	6.7
Metformin and Placebo Group	8.0	7.4	7.5

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Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24

Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model[RMM]) (NCT02268214)
Timeframe: From Baseline to Week 24

Intervention	IU (Least Squares Mean)
Dapagliflozin 5 mg + Insulin	-7.74
Dapagliflozin 10 mg + Insulin	-12.16
Placebo + Insulin	1.16

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Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24

Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) from Baseline at Week 24 (Repeated Measures Model[RMM]) (NCT02268214)
Timeframe: From Baseline to Week 24

Intervention	Percentage (Least Squares Mean)
Dapagliflozin 5 mg + Insulin	6.98
Dapagliflozin 10 mg + Insulin	8.52
Placebo + Insulin	-2.13

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Adjusted Mean Change in HbA1c From Baseline at Week 24

Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model[RMM]). (NCT02268214)
Timeframe: From Baseline to Week 24

Intervention	Percentage of hemoglobin (Least Squares Mean)
Dapagliflozin 5 mg + Insulin	-0.45
Dapagliflozin 10 mg + Insulin	-0.47
Placebo + Insulin	-0.03

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Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24

Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model[RMM]) (NCT02268214)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Least Squares Mean)
Dapagliflozin 5 mg + Insulin	-10.28
Dapagliflozin 10 mg + Insulin	-12.97
Placebo + Insulin	5.06

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Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24

Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model[RMM]) (NCT02268214)
Timeframe: From Baseline to Week 24

Intervention	mg/dL (Least Squares Mean)
Dapagliflozin 5 mg + Insulin	-14.92
Dapagliflozin 10 mg + Insulin	-16.55
Placebo + Insulin	2.38

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Adjusted Mean Percent Change in Body Weight From Baseline at Week 24

Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model[RMM]) (NCT02268214)
Timeframe: From Baseline to Week 24

Intervention	Kg (Least Squares Mean)
Dapagliflozin 5 mg + Insulin	-3.00
Dapagliflozin 10 mg + Insulin	-3.67
Placebo + Insulin	0.05

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Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)

To evaluate the efficacy of the combination therapy (Epanova + Dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline. (NCT02279407)
Timeframe: 12 weeks

Intervention	ratio of % liver fat (Geometric Mean)
Epanova + Dapagliflozin	0.79
Placebo	0.97

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Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)

To evaluate the relative efficacy of the combination of Epanova and dapagliflozin versus Epanova alone and dapagliflozin alone with respect to reduction in % liver fat at the end of 12 weeks of double-blind treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline. (NCT02279407)
Timeframe: 12 weeks

Intervention	ratio of % liver fat (Geometric Mean)
Epanova + Dapagliflozin	0.79
Dapagliflozin	0.87
Epanova	0.85

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Mean Change in HbA1c

(NCT02284893)
Timeframe: Baseline (randomization) to Week 26

Intervention	percentage (%) (Least Squares Mean)
Saxagliptin + Dapagliflozin + Metformin Group	-1.41
SITA + MET	-1.07

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Mean Change in Total Body Weight

(NCT02284893)
Timeframe: Baseline (randomization) to Week 26

Intervention	kg (Mean)
Saxagliptin + Dapagliflozin + Metformin Group	-1.86
SITA + MET	-0.51

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Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%

(NCT02284893)
Timeframe: week 26

Intervention	Percentage of subjects (Number)
Saxagliptin + Dapagliflozin + Metformin Group	37.3
SITA + MET	25.1

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Mean Change in Fasting Plasma Glucose (FPG)

(NCT02284893)
Timeframe: Baseline (randomization) to Week 26

Intervention	mg/dl (Mean)
Saxagliptin + Dapagliflozin + Metformin Group	-31.9
SITA + MET	-11.0

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Waist Circumference (WC)

Waist size (measure of truncal adiposity)with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	centimeters (Mean)
DAPA/MET XR	95.6
Dapaglifloxin	95
Metformin XR	91.7

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Waist- to -Hip Ratio (WHR; Measure of Central Adiposity)

Waist-to-hip ratio with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	Ratio (Mean)
DAPA/MET XR	0.81
Dapaglifloxin	0.80
Metformin XR	0.83

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Waist-to-height Ratio (WHtR)

Waist divided by height a( measure of central adiposity) with combination therapy compared to monotherapy after 24 weeks of therapy (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	ratio (Mean)
DAPA/MET XR	0.58
Dapaglifloxin	0.57
Metformin XR	0.56

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Body Mass Index (BMI)

BMI (measure of overall adiposity) in combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	kg/m2 (Mean)
DAPA/MET XR	33
Dapaglifloxin	33.7
Metformin XR	31

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Change in Body Weight

Change in absolute body weight with combination therapy compared to monotherapy from baseline to week 24 (NCT02338193)
Timeframe: Change from baseline (time 0) to study end (24 weeks)

Intervention	kilograms (Mean)
DAPA/MET XR	-21.5
Dapaglifloxin	-12.5
Metformin XR	-4.4

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Change in Percent Body Weight

Change in percent body weight with combination therapy compared to monotherapy from baseline to week 24 (NCT02338193)
Timeframe: Change from baseline (time 0) to study end (24 weeks)

Intervention	percent weight loss from baseline (Mean)
DAPA/MET XR	-4.9
Dapaglifloxin	-3.2
Metformin XR	-1.1

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Diastolic Blood Pressure (DBP)

Diastolic blood pressure with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment)

Intervention	mmHG (Mean)
DAPA/MET XR	79
Dapaglifloxin	77.8
Metformin XR	79

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Fasting Blood Glucose (FBG)

Fasting blood glucose levels with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	mg/dL (Mean)
DAPA/MET XR	89
Dapaglifloxin	91
Metformin XR	87

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Fasting Insulin Sensitivity (HOMA-IR)

HOMA index of insulin resistance calculated from fasting insulin and glucose with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	Index (Mean)
DAPA/MET XR	2.6
Dapaglifloxin	2.4
Metformin XR	1.8

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First Phase Insulin Secretion (IGI/HOMA-IR)

Corrected early insulin response to glucose challenge [(insulinogenic index (IGI)/ divided by fasting insulin resistance index (HOMA-IR)] with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	Index (Mean)
DAPA/MET XR	1.7
Dapaglifloxin	1.1
Metformin XR	0.77

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Liver Enzymes

ALT/AST ratio with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	Ratio (Mean)
DAPA/MET XR	1.13
Dapaglifloxin	1.12
Metformin XR	1.18

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Matsuda Sensitivity Index (SI OGTT)

Surrogate measure of insulin sensitivity derived from OGTT with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	Index (Mean)
DAPA/MET XR	6.0
Dapaglifloxin	6.3
Metformin XR	5.42

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Mean Blood Glucose (MBG) During an OGTT

Mean blood glucose after glucose load with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	mg/dL (Mean)
DAPA/MET XR	109.5
Dapaglifloxin	110.1
Metformin XR	112.5

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Systolic Blood Pressure (SBP)

Systolic blood pressure with combination therapy compared to monotherapy after 24 weeks of therapy (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	mmHg (Mean)
DAPA/MET XR	125
Dapaglifloxin	124
Metformin XR	119.6

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Total Cholesterol Levels (CHOL)

Cholesterol levels with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	mg/dL (Mean)
DAPA/MET XR	196
Dapaglifloxin	168
Metformin XR	178

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Triglyceride (TRG) Levels

Triglyceride levels with combination therapy compared to monotherapy after 24 weeks of treatment (NCT02338193)
Timeframe: 24 weeks of treatment

Intervention	mg/dL (Mean)
DAPA/MET XR	119
Dapaglifloxin	89.8
Metformin XR	212

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Change From Baseline of Insulin Sensitivity at Week 12

Insulin Sensitivity was estimated by measuring circulating glucose and insulin concentrations after a 12-hour fast and after ingestion of 75 g of glucose. Glucose was measured 5, 10, 15, 20, 30, 45, 60, 75, 90, 105 and 120 minutes after glucose ingestion. Insulin was measured 15, 30, 45, 60, 90 and 120 minutes after glucose ingestion. Insulin sensitivity was estimated using the Matsuda Index, represented by the formula: Matsuda index = 10,000/SQRT [fasting glucose*fasting insulin* (mean glucose from time 5, 10, 15, 20, 30, 45, 60, 75, 90, 105 and 120 minutes) * (mean insulin from time 15, 30, 45, 60, 90 and 120 minutes)], with higher numbers indicating better insulin sensitivity. (NCT02371187)
Timeframe: Baseline, 12 weeks

Intervention	MATSUDA Index (Mean)
	Pre-Training	Post-Training
Dapagliflozin	8.7	9.5
Placebo	8.3	12.9

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Change From Baseline of Fat Free Mass at Week 12

Via dual energy X-ray absorptiometry (NCT02371187)
Timeframe: Baseline, 12 weeks

Intervention	Kilograms (Mean)
	Pre-Exercise Training	Post-Exercise Training
Dapagliflozin	52	52.2
Placebo	57.8	58.3

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Change From Baseline of Respiratory Exchange Ratio at Week 12

The respiratory exchange ratio (RER) is the ratio between the amount of carbon dioxide (CO2) produced in metabolism and oxygen (O2) used during standardized exercise. (NCT02371187)
Timeframe: Baseline, 12 weeks

Intervention	Respiratory Exchange Ratio (Mean)
	Pre-Exercise Training	Post-Exercise Training
Dapagliflozin	1.91	1.19
Placebo	1.16	1.13

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Change From Baseline of Maximal Oxygen Uptake at Week 12

Indirect calorimetry (NCT02371187)
Timeframe: Baseline,12 weeks

Intervention	Milliliters/Kilogram/Minute (Mean)
	Pre-Exercise Training	Post-Exercise Training
Dapagliflozin	26.9	30.6
Placebo	30.1	32.4

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Change From Baseline of Maximal Aerobic Enzyme Activities in Skeletal Muscle at Week 12

Maximal citrate synthase activity in skeletal muscle sample (NCT02371187)
Timeframe: Baseline, 12 weeks

Intervention	micromol/min/miligram protein (Mean)
	Pre-Exercise Training	Post Exercise Training
Dapagliflozin	6.3	8.1
Placebo	5.8	8.0

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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.

"To compare the mean change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The number analyzed represents the number with change from baseline available at Week 24." (NCT02413398)
Timeframe: Baseline, Week 24

Intervention	mg/dL (Mean)
Dapagliflozin	-21.46
Placebo	-4.87

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Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.

"To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The number analyzed represents the number with change from baseline available at Week 24." (NCT02413398)
Timeframe: Baseline, Week 24

Intervention	percent change (Mean)
Dapagliflozin	-3.42
Placebo	-2.02

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Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.

"To compare the mean change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The number analyzed represents the number with change from baseline available at Week 24." (NCT02413398)
Timeframe: Baseline, Week 24

Intervention	mmHg (Mean)
Dapagliflozin	-4.8
Placebo	-1.7

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Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

"To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The number analyzed (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24." (NCT02413398)
Timeframe: Baseline, Week 24

Intervention	percent (Mean)
Dapagliflozin	-0.37
Placebo	-0.03

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Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.

Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period. (NCT02419612)
Timeframe: Up to Week 156

Intervention	Percentage of Subjects (Number)
Dapagliflozin 10mg and Saxagliptin 5mg	37.0
Titrated Glimepiride	55.6

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Change From Baseline in Total Body Weight at Week 52

To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. (NCT02419612)
Timeframe: Baseline and Week 52

Intervention	kilogram (kg) (Least Squares Mean)
Dapagliflozin 10mg and Saxagliptin 5mg	-3.11
Titrated Glimepiride	0.95

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Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52

To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. (NCT02419612)
Timeframe: Baseline and Week 52

Intervention	% HbA1c (Least Squares Mean)
Dapagliflozin 10mg and Saxagliptin 5mg	-1.35
Titrated Glimepiride	-0.98

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Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. (NCT02419612)
Timeframe: Baseline and Week 52

Intervention	mmHg (Least Squares Mean)
Dapagliflozin 10mg and Saxagliptin 5mg	-2.6
Titrated Glimepiride	1.0

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Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.

Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model. (NCT02419612)
Timeframe: Up to Week 156

Intervention	Weeks (Median)
Dapagliflozin 10mg and Saxagliptin 5mg	NA
Titrated Glimepiride	92.3

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Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period

Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period. (NCT02419612)
Timeframe: Up to Week 52

Intervention	Percentage of Subjects (Number)
Dapagliflozin 10mg and Saxagliptin 5mg	1.3
Titrated Glimepiride	8.8

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Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52

Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c. (NCT02419612)
Timeframe: At Week 52

Intervention	Percentage of subjects (Number)
Dapagliflozin 10mg and Saxagliptin 5mg	44.3
Titrated Glimepiride	34.3

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Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156

Therapeutic glycemic response was defined as HbA1c <7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c. (NCT02419612)
Timeframe: At Week 156

Intervention	Percentage of Subjects (Number)
Dapagliflozin 10mg and Saxagliptin 5mg	21.4
Titrated Glimepiride	11.7

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Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake

Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg) (NCT02426541)
Timeframe: From baseline to Week 8

Intervention	umol/min/kg (Least Squares Mean)
Dapagliflozin 10 MG	0.28
Placebo	0.28

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Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8

Adjusted change in liver insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET (NCT02426541)
Timeframe: Baseline to Week 8

Intervention	umol/min/kg (Least Squares Mean)
Dapagliflozin 10 MG	0.27
Placebo	1.59

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Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake

Change in adipose tissue insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET (NCT02426541)
Timeframe: Baseline to Week 8

Intervention	umol/min/kg (Least Squares Mean)
Dapagliflozin 10 MG	1.04
Placebo	-0.64

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