Page last updated: 2024-11-13

canagliflozin

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

canagliflozin hydrate : A hydrate that is the hemihydrate form of canagliflozin. Used for treatment of type II diabetes via inhibition of sodium-glucose transport protein subtype 2. [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]

Cross-References

ID SourceID
PubMed CID24812758
CHEMBL ID2048484
CHEBI ID73274
SCHEMBL ID157162
MeSH IDM0550188

Synonyms (63)

Synonym
HY-10451
842133-18-0
(2s,3r,4r,5s,6r)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
CANAGLIFLOZIN ,
jnj-28431754
ta-7284
ta 7284
invokana
jnj 28431754
BCP9000477
bdbm50386885
canagliflozin hydrate
6s49dgr869 ,
jnj 24831754
hsdb 8284
canagliflozin [inn]
jnj 24831754zae
(1s)-1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-d-glucitol
canagliflozin anhydrous
unii-6s49dgr869
(1s)-1,5-anhydro-1-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4-methylphenyl)-d-glucitol
jnj 24831754aaa
1-(glucopyranosyl)-4-methyl-3-(5-(4-fluorophenyl)-2-thienylmethyl)benzene
d-glucitol, 1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4- methylphenyl)-, (1s)-
d-glucitol, 1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4- methylphenyl)-, (1s)-
chebi:73274 ,
CHEMBL2048484
(1s)-1,5-anhydro-1-(3-{[5-(4-fluorophenyl)-2-thienyl]methyl}-4-methylphenyl)-d-glucitol
BCPP000303
canagliflozin [mi]
canagliflozin [who-dd]
d-glucitol, 1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4-methylphenyl)-
(1s)-1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-d- glucitol
CS-0522
S2760
(1s)-1,5-anhydro-1-c-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-d-glucitol
(1s)-1,5-anhydro-1-c-(3-((5-(4-fluorophenyl)-2-thienyl)methyl)-4-methylphenyl)-d-glucitol
(2s,3r,4r,5s,6r)-2-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)-6-(hydroxymethyl)oxane-3,4,5-triol
gtpl4582
DB08907
smr004702906
MLS006011126
SCHEMBL157162
J-500391
(1s)-1,5-anhydro-1-(3-{[5-(4-fluorophenyl)-2-thienyl]methyl}-4-methyl-phenyl)-d-glucitol
XTNGUQKDFGDXSJ-ZXGKGEBGSA-N
AC-26303
AKOS025401827
(2s,3r,4r,5s,6r)-2-[3-[[5-(4-fluorophenyl)thiophen-2-yl]methyl]-4-methylphenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
CCG-229581
jnj 28431754aaa
KS-1443
mfcd18251436
SW219119-1
Q5030940
AMY3291
NCGC00346691-02
d-glucitol,1,5-anhydro-1-c-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-, (1s)-
jnj24831754zae; ta 7284;(2s,3r,4r,5s,6r)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol
A25050
DTXSID601004469
EN300-6733492
Z2235801995

Research Excerpts

Overview

Canagliflozin (CANA) is a sodium glucose co-transporter (SGLT) 2 inhibitor in clinical development for the treatment of type 2 diabetes mellitus (T2DM) It lowers blood glucose levels by increasing urinary glucose excretion.

ExcerptReferenceRelevance
"Canagliflozin is a sodium glucose co-transporter (SGLT) 2 inhibitor in clinical development for the treatment of type 2 diabetes mellitus (T2DM)."( Effect of canagliflozin on renal threshold for glucose, glycemia, and body weight in normal and diabetic animal models.
Arakawa, K; Conway, B; Conway, J; Demarest, K; Du, F; Kuriyama, C; Liang, Y; Liu, Y; Martin, T; Matsushita, Y; Polidori, D; Ueta, K; Ways, K; Xu, J, 2012
)
2.22
"Canagliflozin (CANA) is a sodium-glucose cotransporter 2 inhibitor that was recently approved for treating diabetes. "( Canagliflozin Improves Liver Function in Rats by Upregulating Asparagine Synthetase.
Ding, Y; Dong, R; Meng, S; Wang, H; Wang, S; Yin, L, 2021
)
3.51
"Canagliflozin is a sodium–glucose cotransporter 2 (SGLT2) inhibitor that lowers blood glucose levels by increasing urinary glucose excretion. "( Real-World Safety and Effectiveness of Canagliflozin Treatment for Type 2 Diabetes Mellitus in Japan: SAPPHIRE, a Long-Term, Large-Scale Post-Marketing Surveillance.
Hamada, K; Inagaki, N; Iwasaki, T; Mori-Anai, K; Nangaku, M; Sakata, Y; Sasaki, K, 2022
)
2.43
"Canagliflozin is an antidiabetic medicine that inhibits sodium-glucose cotransporter 2 (SGLT2) in proximal tubules. "( Anti-diabetic drug canagliflozin hinders skeletal muscle regeneration in mice.
Chen, WA; Chen, X; Cong, XX; Li, ZZ; Lin, YN; Lu, XM; Lv, XH; Nan, JL; Shen, J; Su, L; Wang, BB; Wang, ZT; Zhou, RY; Zhu, QL, 2022
)
2.49
"Canagliflozin is a sodium glucose-cotransporter-2 receptor inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM). "( Effects of different doses of canagliflozin on blood pressure and lipids in patients with type 2 diabetes: a meta-analysis.
Geng, Q; Hou, F; Wang, Z; Zhang, Y; Zhao, M, 2022
)
2.45
"Canagliflozin is an oral hypoglycemic drug recently formulated in combination with a biguanide, metformin hydrochloride, for improving its hypoglycemic action. "( Ecofriendly appraisal of stability-indicating high-performance chromatographic assay of canagliflozin and metformin with their toxic impurities; in silico toxicity prediction.
Emam, AA; Emam, RA, 2023
)
2.58
"Canagliflozin (CANA) is an SGLT2i, which is widely prescribed, to reduce cardiovascular complications, and as a second-line therapy after metformin in the treatment of type 2 diabetes mellitus."( Long-term effects of canagliflozin treatment on the skeleton of aged UM-HET3 mice.
Bergamo, ETP; Bromage, TG; Chlebek, C; Dixit, M; Harrison, DE; Hu, B; Ladiges, W; Mijares, DQ; Miller, RA; Poudel, SB; Rosen, CJ; Ruff, RR; Strong, R; Witek, L; Yakar, S; Yildirim, G, 2023
)
1.95
"Canagliflozin (CFZ) is a sodium-glucose cotransporter-2 inhibitor (SGLT2) that lowers albuminuria in type-2 diabetic patients, cardiovascular, kidney, and liver disease. "( Development of canagliflozin nanocrystals sublingual tablets in the presence of sodium caprate permeability enhancer: formulation optimization, characterization,
Abdelaal, N; Alshawwa, SZ; El-Nabarawi, MA; Elfar, N; Elnawawy, T; Elrefai, MFM; Elzohairy, NA; Fathy Elhabal, S; Gad, RA; Ghaffar, SA; Hamdan, AME; Khalifa, MM; Khasawneh, MA; Mohammed, H; Mohie, PM; Saied, EM; Waggas, DS, 2023
)
2.71
"Canagliflozin is a promising drug for treatment of ID horses that requires future studies."( Short-term effects of canagliflozin on glucose and insulin responses in insulin dysregulated horses: A randomized, placebo-controlled, double-blind, study.
Bergsten, P; Bröjer, J; Forslund, A; Lindåse, S; Nostell, K,
)
1.89
"Canagliflozin is a widely used antihyperglycemic agent, a sodium-glucose cotransporter-2 (SGLT2) inhibitor that enhances urinary glucose excretion."( Canagliflozin ameliorates ulcerative colitis via regulation of TLR4/MAPK/NF-κB and Nrf2/PPAR-γ/SIRT1 signaling pathways.
Ali, FEM; Althagafy, HS; Atwa, AM; Hassanein, EHM; Kotb El-Sayed, MI; Mohammedsaleh, ZM; Sayed, AM; Soubh, AA, 2023
)
3.07
"Canagliflozin (CANA) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor with blood glucose lowering effects. "( Sex-dependent effects of Canagliflozin on kidney protection in mice with combined hypertension-type 1 diabetes.
Cheff, V; Gutsol, A; Hébert, RL; Trentin-Sonoda, M, 2023
)
2.66
"Canagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor which received U.S. "( Canagliflozin-induced Fanconi syndrome in a patient with previously unrecognized type 1 diabetes.
Broussard, J; Dziuba, M; Khan, N; Tso, K, 2019
)
3.4
"Canagliflozin is a US FDA-approved SGLT2 inhibitor that has demonstrated CV and renal outcome benefits in large scale placebo-controlled randomized trials of patients with Type 2 diabetes mellitus and elevated CV risk."( Canagliflozin and cardiovascular outcomes in Type 2 diabetes.
Mahaffey, KW; Rodriguez, F; Sarraju, A; Spencer-Bonilla, G, 2021
)
2.79
"Canagliflozin (CANA) is a sodium‑glucose co‑transporter 2 inhibitor used for the clinical treatment of diabetes."( Inhibitory effects of canagliflozin on pancreatic cancer are mediated via the downregulation of glucose transporter‑1 and lactate dehydrogenase A.
Ding, J; He, L; Pang, S; Shen, B; Xie, X; Xu, D; Zhou, C; Zhou, Y, 2020
)
1.59
"Canagliflozin (Cana) is an FDA-approved diabetes drug that protects against cardiovascular and kidney diseases. "( Canagliflozin extends life span in genetically heterogeneous male but not female mice.
Allison, DB; Bogue, M; Debarba, L; Diaz, V; Fernandez, E; Galecki, A; Garvey, WT; Harrison, DE; Javors, MA; Jayarathne, H; Kumar, N; Ladiges, WC; Lombard, DB; Macchiarini, F; Miller, RA; Nelson, J; Reifsnyder, P; Rosenthal, NA; Sadagurski, M; Salmon, AB; Smith, DL; Snyder, JM; Strong, R, 2020
)
3.44
"Canagliflozin is an SGLT2 inhibitor that provides sustained reductions in HbA1c, blood pressure and weight."( Canagliflozin: metabolic, cardiovascular and renal protection.
Barrios, V; Escobar, C, 2021
)
2.79
"Canagliflozin is an antidiabetic agent which lowers blood glucose levels by inhibiting the glucose reabsorption machinery in the proximal tubules. "( Canagliflozin ameliorates aortic and hepatic dysfunction in dietary-induced hypercholesterolemia in the rabbit.
Abdelaziz, RR; Ashry, NA; Saleh, MA; Suddek, GM, 2021
)
3.51
"Canagliflozin (CAN) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated to improve glycemic control in adults with type 2 diabetes mellitus. "( Canagliflozin prevents scopolamine-induced memory impairment in rats: Comparison with galantamine hydrobromide action.
Ali, EHA; Arafa, NMS; Hassan, MK, 2017
)
3.34
"Canagliflozin is a newly approved drug for type II diabetes mellitus. "( Canagliflozin stability study and ecofriendly chromatographic determination of its degradation product: A comparative study.
Emam, AA, 2018
)
3.37
"Canagliflozin is a sodium-glucose cotransporter (SGLT) 2 inhibitor, and it also exerts a modest inhibitory effect on SGLT1."( Canagliflozin reduces plasma uremic toxins and alters the intestinal microbiota composition in a chronic kidney disease mouse model.
Abe, T; Asaji, K; Fukuda, NN; Fukuda, S; Ho, HJ; Ito, S; Kanemitsu, Y; Kikuchi, K; Matsumoto, Y; Mishima, E; Mukawa, C; Nanto, F; Saigusa, D; Soga, T; Suzuki, C; Suzuki, T; Tachikawa, T; Tomioka, Y; Tsukamoto, H; Tsukimi, T, 2018
)
2.64
"Canagliflozin is a sodium glucose cotransporter 2 inhibitor that reduces the risk of cardiovascular events. "( Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program.
Barrett, TD; de Zeeuw, D; Desai, M; Figtree, G; Fulcher, G; Mahaffey, KW; Matthews, DR; Neal, B; Perkovic, V; Rådholm, K; Shaw, W; Solomon, SD, 2018
)
3.37
"Canagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor that is currently available for the management of type 2 diabetes mellitus. "( Effect of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on cisplatin-induced nephrotoxicity in mice.
Abdelrahman, AM; Al Suleimani, Y; Ali, BH; Ashique, M; Manoj, P; Nemmar, A; Shalaby, A, 2019
)
2.36
"Canagliflozin is a novel drug for diabetes mellitus with the mechanisms of inducing glucosuria through inhibition of the sodium-glucose cotransporter 2 in the kidney independent of insulin activity. "( Metabolic Acidosis in Postsurgical Patient on Canagliflozin and Metformin: A Case Report.
Darwish, AM, 2019
)
2.21
"Canagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor that reduces blood glucose, as well as blood pressure, body weight, and albuminuria in patients with type 2 diabetes mellitus (T2DM). "( The CANVAS Program: implications of canagliflozin on reducing cardiovascular risk in patients with type 2 diabetes mellitus.
Carbone, S; Dixon, DL, 2019
)
2.23
"Canagliflozin is a sodium glucose co-transporter 2 inhibitor in development for treatment of type 2 diabetes mellitus (T2DM). "( Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease.
Bakris, G; Cariou, B; David-Neto, E; Figueroa, K; Meininger, G; Usiskin, K; Wajs, E; Xi, L; Yale, JF; Yue, D, 2013
)
2.14
"Canagliflozin is an orally administered sodium glucose cotransporter 2 inhibitor proposed for the treatment of type 2 diabetes. "( Canagliflozin , an inhibitor of sodium-glucose cotransporter 2, for the treatment of type 2 diabetes mellitus.
Davis, SN; Lamos, EM; Younk, LM, 2013
)
3.28
"Canagliflozin is a sodium glucose co-transporter 2 inhibitor developed for the treatment of patients with type 2 diabetes mellitus (T2DM). "( Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial.
Bode, B; Fung, A; Stenlöf, K; Sullivan, D; Usiskin, K, 2013
)
2.14
"Canagliflozin is a sodium glucose co-transporter 2 inhibitor developed for treatment of type 2 diabetes mellitus (T2DM). "( Long-term efficacy and safety of canagliflozin monotherapy in patients with type 2 diabetes inadequately controlled with diet and exercise: findings from the 52-week CANTATA-M study.
Alba, M; Canovatchel, W; Cefalu, WT; Edwards, R; Jodar, E; Kim, KA; Meininger, G; Stenlöf, K; Tong, C, 2014
)
2.13
"Canagliflozin is a sodium glucose co-transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2DM). "( Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial.
Black, S; Canovatchel, W; Charpentier, G; González-Gálvez, G; Hollander, P; Law, G; Mathieu, C; Meininger, G; Usiskin, K; Vercruysse, F; Wilding, JP, 2013
)
2.14
"Canagliflozin is a newly approved drug for the treatment of type 2 diabetes. "( Safety of canagliflozin in patients with type 2 diabetes.
Mikhail, N, 2014
)
2.25
"Canagliflozin is an oral antihyperglycemic agent used for the treatment of type 2 diabetes mellitus. "( Metabolism and excretion of canagliflozin in mice, rats, dogs, and humans.
Chen, J; Cuyckens, F; Devineni, D; Evans, DC; Johnson, MD; Kalamaridis, D; Kelley, MF; Lim, HK; Lin, R; Mamidi, RN; Scheers, E; Sha, S; Silva, J, 2014
)
2.14
"Canagliflozin is a sodium glucose co-transporter 2 inhibitor developed for the treatment of patients with type 2 diabetes mellitus (T2DM). "( Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies.
Bode, B; Desai, M; Fung, A; Harris, S; Mayer, C; Meininger, G; Shaw, W; Sinclair, A; Usiskin, K; Vijapurkar, U, 2014
)
2.16
"Canagliflozin (Invokana™) is an orally administered sodium-glucose co-transporter-2 (SGLT2) inhibitor used in the treatment of patients with type 2 diabetes. "( Canagliflozin: a review of its use in patients with type 2 diabetes mellitus.
Plosker, GL, 2014
)
3.29
"Canagliflozin is a sodium glucose cotransporter 2 inhibitor developed for treating type 2 diabetes mellitus (T2DM)."( Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results.
Fung, A; Kline, I; Mayer, C; Meininger, G; Usiskin, K, 2014
)
2.14
"Canagliflozin is a sodium glucose co-transporter 2 inhibitor approved for treating patients with type 2 diabetes. "( Canagliflozin, a sodium glucose co-transporter 2 inhibitor, reduces post-meal glucose excursion in patients with type 2 diabetes by a non-renal mechanism: results of a randomized trial.
Artis, E; Berg, JK; Devineni, D; Morrow, L; Polidori, D; Rusch, S; Stein, P; Vaccaro, N, 2014
)
3.29
"Canagliflozin is an SGLT2 inhibitor used for the treatment of type 2 diabetes mellitus. "( Carbohydrate malabsorption mechanism for tumor formation in rats treated with the SGLT2 inhibitor canagliflozin.
Bryant, S; De Jonghe, S; Feyen, B; Johnson, MD; Kelley, MF; Lammens, G; Louden, C; Ma, JY; Mamidi, RN; Moesen, E; Proctor, J; Snook, S; Vinken, P; Ways, K, 2014
)
2.06
"Canagliflozin is a sodium glucose cotransporter 2 inhibitor for patients with type 2 diabetes and can be given as monotherapy or in combination with other agents, including insulin. "( Canagliflozin: a new option for managing diabetes.
Clements, JN; Livingston, M, 2014
)
3.29
"Canagliflozin is a new drug in class of sodium-glucose cotransporter 2 inhibitors used for treatment of type 2 diabetes mellitus. "( Canagliflozin-Associated Acute Pancreatitis.
Verma, R,
)
3.02
"Canagliflozin is a sodium glucose co-transporter 2 inhibitor that has been shown to improve glycemic control in type 2 diabetes mellitus (T2DM). "( Characteristics and short-term outcomes of patients with type 2 diabetes mellitus treated with canagliflozin in a real-world setting.
Buysman, EK; Chow, W; Henk, HJ; Rupnow, MF, 2015
)
2.08
"Canagliflozin is a sodium-glucose cotransporter 2 inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM). "( Effect of hepatic or renal impairment on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor.
Curtin, CR; Devineni, D; Marbury, TC; Rusch, S; Smith, W; Stieltjes, H; Vaccaro, N; Vandebosch, A; Wajs, E; Wexler, D, 2015
)
2.1
"Canagliflozin is an inhibitor of sodium-glucose cotransporters type 2 (SGLT2) that are present in renal tubules. "( [Canagliflozin (Invokana): kidney SGLT2 cotransporter inhibitor for treating type 2 diabetes].
Scheen, AJ, 2014
)
2.76
"Canagliflozin is an orally active, reversible, selective SGLT2 inhibitor."( Clinical Pharmacokinetic, Pharmacodynamic, and Drug-Drug Interaction Profile of Canagliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor.
Devineni, D; Polidori, D, 2015
)
1.37
"Canagliflozin is a competitive, reversible, highly selective SGLT2 inhibitor and available in 100mg and 300mg as oral tablet form. "( A Systematic Review on Effect of Canagliflozin in Special Population.
Gohel, K; Patel, BG; Patel, S, 2016
)
2.16
"Canagliflozin is a sodium glucose co-transporter 2 inhibitor approved worldwide for the treatment of patients with type 2 diabetes mellitus (T2DM). "( Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus.
Iijima, H; Inagaki, N; Kifuji, T; Maruyama, N, 2015
)
2.11
"Canagliflozin is a potential option as an add-on to metformin based on its improvement in HbA1c, FPG, body weight, and β cell function, but further studies are demanded to strengthen this evidence. "( Efficacy and tolerability of canagliflozin as add-on to metformin in the treatment of type 2 diabetes mellitus: a meta-analysis.
Cui, Y; Lu, M; Ma, L; Yang, T; Zhou, Y, 2015
)
2.15
"Canagliflozin is an orally active, reversible, selective sodium-glucose co-transporter-2 inhibitor. "( Population Pharmacokinetic Modeling of Canagliflozin in Healthy Volunteers and Patients with Type 2 Diabetes Mellitus.
De Winter, W; Devineni, D; Dunne, A; Hoeben, E; Neyens, M; Vermeulen, A, 2016
)
2.15
"Canagliflozin is a sodium glucose cotransporter 2 inhibitor developed to treat type 2 diabetes mellitus (T2DM)."( Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin.
Bilezikian, JP; Fung, A; Polidori, D; Rosenthal, N; Sullivan, D; Usiskin, K; Watts, NB, 2016
)
2.09
"Canagliflozin is a sodium glucose cotransporter 2 inhibitor developed to treat type 2 diabetes mellitus (T2DM)."( Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus.
Bilezikian, JP; Desai, M; Edwards, R; Law, G; Meininger, G; Usiskin, K; Watts, NB, 2016
)
2.27
"Canagliflozin is a novel, orally selective inhibitor of sodium-dependent glucose co-transporter-2 (SGLT2) for the treatment of patients with type 2 diabetes mellitus. "( A validated LC-MS/MS method for the determination of canagliflozin, a sodium-glucose co-transporter 2 (SGLT-2) inhibitor, in a lower volume of rat plasma: application to pharmacokinetic studies in rats.
Ito, Y; Kobuchi, S; Sakaeda, T; Yano, K, 2016
)
2.13
"Canagliflozin is a recently developed sodium-glucose cotransporter (SGLT) 2 inhibitor that promotes renal glucose excretion and is considered to inhibit renal SGLT2 from the luminal side of proximal tubules. "( Physiologically based pharmacokinetic-pharmacodynamic modeling to predict concentrations and actions of sodium-dependent glucose transporter 2 inhibitor canagliflozin in human intestines and renal tubules.
Mori, K; Nakamaru, Y; Saito, R; Shimizu, M; Yamazaki, H, 2016
)
2.08
"Canagliflozin is a recently approved drug for use in the treatment of type 2 diabetes. "( In vitro and physiologically-based pharmacokinetic based assessment of drug-drug interaction potential of canagliflozin.
Cuyckens, F; Dallas, S; Evans, DC; Johnson, MD; Kelley, MF; Leclercq, L; Lim, HK; Mamidi, RNVS; Scheers, E; Sensenhauser, C; Snoeys, J; Verboven, P, 2017
)
2.11
"Canagliflozin is a new SGLT2 inhibitor which has been approved as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes (T2D) mellitus in more than 30 countries. "( Efficacy and safety of canagliflozin in patients with type 2 diabetes: A meta-analysis of randomized controlled trials.
Chang, F; Xiao, MY; Xiong, W; Zhang, M, 2016
)
2.19
"Canagliflozin is an SGLT2 inhibitor approved for the treatment of type-2 diabetes. "( Dynamic population pharmacokinetic-pharmacodynamic modelling and simulation supports similar efficacy in glycosylated haemoglobin response with once or twice-daily dosing of canagliflozin.
de Trixhe, XW; de Winter, W; Devineni, D; Dunne, A; Hsu, CH; Pinheiro, J; Polidori, D, 2017
)
2.09
"Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that is being investigated for the treatment of type 2 diabetes mellitus (T2DM)."( Canagliflozin improves glycaemic control over 28 days in subjects with type 2 diabetes not optimally controlled on insulin.
Devineni, D; Hompesch, M; Morrow, L; Murphy, J; Schwartz, S; Skee, D; Vandebosch, A; Ways, K, 2012
)
3.26
"Canagliflozin is a sodium glucose co-transporter 2 inhibitor in development for type 2 diabetes mellitus (T2DM). "( Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise.
Alba, M; Canovatchel, W; Cefalu, WT; Kim, KA; Meininger, G; Stenlöf, K; Tong, C; Usiskin, K, 2013
)
2.14

Effects

Canagliflozin has a low risk of hypoglycaemia. Was generally well tolerated in clinical trials. Has a robust inhibitory effect on sodium glucose transporter (SGLT)-2 and a mild inhibitory Effect on SGLT1.

Canagliflozin (CANA) has been shown to improve HbA1c, blood pressure (BP), and weight in patients with type 2 diabetes mellitus (T2DM) in clinical trials. Canaglif lozin has been proposed as an effective treatment for type 2 diabetes.

ExcerptReferenceRelevance
"Canagliflozin has a robust inhibitory effect on sodium glucose transporter (SGLT)-2 and a mild inhibitory effect on SGLT1. "( Effect of canagliflozin on circulating active GLP-1 levels in patients with type 2 diabetes: a randomized trial.
Hara, K; Inukai, T; Naruse, R; Suetsugu, M; Takebayashi, K; Terasawa, T; Tsuchiya, T, 2017
)
2.3
"Canagliflozin has a low risk of hypoglycaemia and was generally well tolerated in clinical trials."( Canagliflozin: a review of its use in patients with type 2 diabetes mellitus.
Plosker, GL, 2014
)
2.57
"Canagliflozin has been shown to increase the activity of the AMP-activated protein kinase (AMPK), a metabolic energy sensor important for increasing fatty acid oxidation and energy expenditure and suppressing lipogenesis and inflammation, but whether AMPK activation is important for mediating some of the beneficial metabolic effects of canagliflozin has not been determined."( The SGLT2 inhibitor canagliflozin suppresses lipid synthesis and interleukin-1 beta in ApoE deficient mice.
Day, EA; Desjardins, EM; Ford, RJ; Green, AE; Lally, JSV; Lu, JH; Lu, R; Lundenberg, L; Schertzer, JD; Steinberg, GR, 2020
)
1.6
"Canagliflozin treatment has been shown to provide glycaemic improvements as well as reductions in blood pressure and body weight across a broad range of patients with T2DM, including those with elevated cardiovascular risk. "( Effects of canagliflozin on cardiovascular risk factors in patients with type 2 diabetes mellitus.
Budoff, MJ; Wilding, JPH, 2017
)
2.29
"Canagliflozin (CANA) has been shown to improve HbA1c, blood pressure (BP), and weight in patients with type 2 diabetes mellitus (T2DM) in clinical trials. "( Real-world glycemic, blood pressure, and weight control in patients with type 2 diabetes mellitus treated with canagliflozin-an electronic health-record-based study.
Chow, W; Duh, MS; Lafeuille, MH; Lefebvre, P; Pfeifer, M; Pilon, D; Robitaille, MN, 2016
)
2.09
"Canagliflozin has been proposed as an effective treatment for type 2 diabetes. "( Efficacy of canagliflozin combined with antidiabetic drugs in treating type 2 diabetes mellitus: Meta-analysis of randomized control trials.
Jiang, F; Liu, D; Meng, Q; Shen, Y, 2016
)
2.26

Actions

Canagliflozin can inhibit SGLT-1 at therapeutic levels; however, the underlying molecular mechanism is not understood. It failed to produce an additive effect to improve beta cell glucose sensitivity above that observed with liraglutide.

ExcerptReferenceRelevance
"Canagliflozin can inhibit SGLT-1 at therapeutic levels; however, the underlying molecular mechanism is not understood."( Canagliflozin protects diabetic cardiomyopathy by mitigating fibrosis and preserving the myocardial integrity with improved mitochondrial function.
Dasari, D; Dhar, A; Goyal, SG; Penmetsa, A; Sriram, D, 2023
)
3.07
"Canagliflozin failed to produce an additive effect to improve beta cell glucose sensitivity above that observed with liraglutide."( Improved Beta Cell Glucose Sensitivity Plays Predominant Role in the Decrease in HbA1c with Cana and Lira in T2DM.
Abdul-Ghani, M; Adams, J; Al-Jobori, H; Ali, AM; Cersosimo, E; DeFronzo, R; Mari, A; Martinez, R; Triplitt, C, 2020
)
1.28
"Canagliflozin was shown to increase the risks of amputation and bone fracture compared with placebo when using the difference in RMST."( Effects of Sodium-glucose Cotransporter 2 Inhibitors on Amputation, Bone Fracture, and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus Using an Alternative Measure to the Hazard Ratio.
Kaneko, M; Narukawa, M, 2019
)
1.96
"Canagliflozin did not cause hypoglycemia, consistent with the RTG values remaining above the hypoglycemia threshold."( Pharmacodynamic effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, from a randomized study in patients with type 2 diabetes.
Arnolds, S; Demarest, K; Devineni, D; Ghosh, A; Hompesch, M; Morrow, L; Polidori, D; Rothenberg, P; Sha, S; Spitzer, H, 2014
)
1.42
"Canagliflozin did not cause hypoglycemia, consistent with the RTG values remaining above the hypoglycemia threshold."( Pharmacodynamic effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, from a randomized study in patients with type 2 diabetes.
Arnolds, S; Demarest, K; Devineni, D; Ghosh, A; Hompesch, M; Morrow, L; Polidori, D; Rothenberg, P; Sha, S; Spitzer, H, 2014
)
1.42

Treatment

Canagliflozin treatment improved glycaemic control, reduced body weight and was generally well tolerated in subjects with T2DM inadequately controlled with diet and exercise. Treatment with canaglif lozin did not significantly change IGF-1 and IGFBP-3 concentrations by 3 years (p-value > 0.05)

ExcerptReferenceRelevance
"Canagliflozin treatment reduced KidneyIntelX risk scores over time and changes in the KidneyIntelX score from baseline to 1 year associated with future risk of DKD progression, independent of the baseline risk score and treatment arm."( Clinical Utility of KidneyIntelX in Early Stages of Diabetic Kidney Disease in the CANVAS Trial.
Coca, SG; Fleming, F; Hansen, MK; Heerspink, HJL; Lam, D; Mahaffey, KW; Mosoyan, G; Nadkarni, GN; Neal, B; Rosenthal, N, 2022
)
1.44
"Canagliflozin treatment significantly increased plasma FFA and β-hydroxybutyrate regardless of background antihyperglycemic therapy."( Fasting Substrate Concentrations Predict Cardiovascular Outcomes in the CANagliflozin cardioVascular Assessment Study (CANVAS).
Baldi, S; Ferrannini, E; Figtree, GA; Hansen, MK; Mahaffey, KW; Neal, B; Perkovic, V; Rosenthal, N; Scozzaro, T; Shaw, W; Tesfaye, F; Tsimihodimos, V, 2022
)
1.68
"Canagliflozin treatment significantly reduced ALT, AST, and γGT over time."( Liver function markers predict cardiovascular and renal outcomes in the CANVAS Program.
Ferrannini, E; Ferrannini, G; Hansen, MK; Rosenthal, N, 2022
)
1.44
"Canagliflozin treatment significantly reduced high-salt-induced hypertension and this effect was not totally dependent on urinary sodium excretion in salt-sensitive hypertensive rats."( Sodium-Glucose Cotransporter 2 Inhibitor Canagliflozin Antagonizes Salt-Sensitive Hypertension Through Modifying Transient Receptor Potential Channels 3 Mediated Vascular Calcium Handling.
Cao, T; Gao, P; He, C; Hu, Y; Li, L; Li, Q; Liu, D; Lu, Z; Luo, Z; Shu, W; Sun, F; Wang, L; Yan, Z; Zhang, H; Zhao, Y; Zhu, Z, 2022
)
1.71
"Canagliflozin treatment significantly reduced insulin concentrations at week 24 (p < 0.001), and the between-group difference (canagliflozin minus glimepiride) in those changes was - 3.52 mU/L (95% confidence interval, - 4.85 to - 2.19; p < 0.001)."( Association between serum insulin levels and heart failure-related parameters in patients with type 2 diabetes and heart failure treated with canagliflozin: a post-hoc analysis of the randomized CANDLE trial.
Ako, J; Imai, T; Node, K; Sezai, A; Shimabukuro, M; Taguchi, I; Tanaka, A; Toyoda, S; Watada, H, 2022
)
1.64
"Canagliflozin treatment attenuated these changes."( Canagliflozin protects diabetic cardiomyopathy by mitigating fibrosis and preserving the myocardial integrity with improved mitochondrial function.
Dasari, D; Dhar, A; Goyal, SG; Penmetsa, A; Sriram, D, 2023
)
3.07
"Canagliflozin treatment alone moderately inhibited mitochondrial oxidative phosphorylation and exhibited greater antiproliferative capacity than specific mitochondrial complex-I inhibitors."( Canagliflozin mediates tumor suppression alone and in combination with radiotherapy in non-small cell lung cancer (NSCLC) through inhibition of HIF-1α.
Abdulkarim, B; Ahmadi, E; Ali, A; Berg, T; Biziotis, OD; Bramson, JL; Ellis, P; Farrell, T; Mekhaeil, B; Menjolian, G; Mesci, A; Muti, P; Singh, K; Steinberg, GR; Sur, RK; Tsakiridis, EE; Tsakiridis, T; Wang, S; Wu, J, 2023
)
3.07
"Canagliflozin treatment significantly reduced right ventricular systolic pressure and increased pulmonary acceleration time determined by hemodynamic assessments."( Canagliflozin ameliorates hypobaric hypoxia-induced pulmonary arterial hypertension by inhibiting pulmonary arterial smooth muscle cell proliferation.
Cai, Q; Chen, L; Li, X; Tang, L; Wang, X; Yang, Y, 2023
)
3.07
"Canagliflozin treatment decreased fat mass and increased energy expenditure via increasing thermogenesis and lipolysis in adipose tissue."( Inhibition of the sodium-glucose co-transporter SGLT2 by canagliflozin ameliorates diet-induced obesity by increasing intra-adipose sympathetic innervation.
Chen, L; Cheng, S; Ding, Y; He, J; Huang, Y; Jiang, W; Li, R; Li, Y; Liu, Q; Pu, S; Shi, X; Tang, Q; Wang, R; Wu, T; Yang, X; Zhang, J; Zhang, Z; Zhao, Y; Zou, M, 2021
)
1.59
"Canagliflozin treatment has been shown to provide glycaemic improvements as well as reductions in blood pressure and body weight across a broad range of patients with T2DM, including those with elevated cardiovascular risk. "( Effects of canagliflozin on cardiovascular risk factors in patients with type 2 diabetes mellitus.
Budoff, MJ; Wilding, JPH, 2017
)
2.29
"Canagliflozin treatment improved BG in DM mice by ~35%, but did not improve microarchitectural parameters."( SGLT2 inhibitor therapy improves blood glucose but does not prevent diabetic bone disease in diabetic DBA/2J male mice.
Clay Bunn, R; Cockrell, GE; Fowlkes, JL; Lumpkin, CK; Nyman, JS; Rettiganti, MR; Thrailkill, KM; Uppuganti, S; Wahl, EC, 2016
)
1.16
"Canagliflozin treatment was associated with an increase in vaginal colonization with Candida species and in VVAE in women with T2DM."( Evaluation of vulvovaginal symptoms and Candida colonization in women with type 2 diabetes mellitus treated with canagliflozin, a sodium glucose co-transporter 2 inhibitor.
Nyirjesy, P; Usiskin, K; Ways, K; Zhao, Y, 2012
)
2.03
"Canagliflozin treatment improved glycaemic control, reduced body weight and was generally well tolerated in subjects with T2DM inadequately controlled with diet and exercise."( Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise.
Alba, M; Canovatchel, W; Cefalu, WT; Kim, KA; Meininger, G; Stenlöf, K; Tong, C; Usiskin, K, 2013
)
2.14
"Treatment with canagliflozin 1 mg/kg lowered RT(G) from 415±12 mg/dl to 94±10 mg/dl in ZDF rats while maintaining a threshold relationship between BG and UGE with virtually no UGE observed when BG was below RT(G). "( Effect of canagliflozin on renal threshold for glucose, glycemia, and body weight in normal and diabetic animal models.
Arakawa, K; Conway, B; Conway, J; Demarest, K; Du, F; Kuriyama, C; Liang, Y; Liu, Y; Martin, T; Matsushita, Y; Polidori, D; Ueta, K; Ways, K; Xu, J, 2012
)
1.13
"Treatment with canagliflozin increased the proportion of Th1 cells by 2.3 times, decreased the proportion of Th2 cells by 68.5%, and significantly restrained the synthesis of immunoglobulin G1 in B-cells and glomerulus subepithelial immune complex deposition."( Canagliflozin reverses Th1/Th2 imbalance and promotes podocyte autophagy in rats with membranous nephropathy.
Li, J; Lin, Y; Liu, H; Lv, X; Ma, G; Shao, X; Wang, J; Yu, P; Zhang, L; Zhou, S, 2022
)
2.5
"Treatment with canagliflozin did not significantly change IGF-1 and IGFBP-3 concentrations by 3 years (p-value > 0.05)."( Insulin growth factor axis and cardio-renal risk in diabetic kidney disease: an analysis from the CREDENCE trial.
Butler, J; Hansen, MK; Heerspink, HJL; Januzzi, JL; Jardine, M; Liu, Y; Masson, S; Mohebi, R; Pollock, CA; Sattar, N; Yavin, Y, 2023
)
1.25
"Mice treated with canagliflozin were resistant to high-fat diet-induced obesity and its metabolic consequences. "( Inhibition of the sodium-glucose co-transporter SGLT2 by canagliflozin ameliorates diet-induced obesity by increasing intra-adipose sympathetic innervation.
Chen, L; Cheng, S; Ding, Y; He, J; Huang, Y; Jiang, W; Li, R; Li, Y; Liu, Q; Pu, S; Shi, X; Tang, Q; Wang, R; Wu, T; Yang, X; Zhang, J; Zhang, Z; Zhao, Y; Zou, M, 2021
)
1.2
"Treatment with canagliflozin was associated with development of euglycemic ketoacidosis."( ‘Euglycemic’ Ketoacidosis in a Patient With Type 2 Diabetes Being Treated With Canagliflozin.
Chan, P; Danford, C; Magill, SB, 2016
)
1.01
"In untreated and canagliflozin-treated subjects, the relationship between UGE rate and BG was well described by a threshold relationship. "( Validation of a novel method for determining the renal threshold for glucose excretion in untreated and canagliflozin-treated subjects with type 2 diabetes mellitus.
Ghosh, A; Heise, T; Plum-Mörschel, L; Polidori, D; Rothenberg, P; Sha, S, 2013
)
0.94
"Treatment with canagliflozin for 12 weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM. "( Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, 12-week study.
Inagaki, N; Kondo, K; Kuki, H; Maruyama, N; Susuta, Y; Yoshinari, T, 2013
)
1.05
"Treatment with canagliflozin for 6 to 12 months improved model-based measures of beta cell function in three separate Phase 3 studies."( Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes.
Ferrannini, E; Mari, A; Polidori, D, 2014
)
2.2
"Treatment with canagliflozin for 8 weeks from the prediabetic stage suppressed the progression of hyperglycemia, prevented the decrease in plasma insulin levels, increased pancreatic insulin contents, and minimized the deterioration of islet structure."( Analysis of the effect of canagliflozin on renal glucose reabsorption and progression of hyperglycemia in zucker diabetic Fatty rats.
Arakawa, K; Hikida, K; Kakimoto, T; Kimata, H; Kuriyama, C; Lee, SP; Matsushita, Y; Nakayama, K; Qi, J; Saito, A; Shiotani, M; Taniuchi, N; Ueta, K; Watanabe, Y; Xu, JZ, 2014
)
1.04
"Treatment with canagliflozin was associated with an increased rate of genital mycotic infections (GMIs) and urinary tract infections (UTIs) in all racial groups."( The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus.
Alba, M; Davies, M; Davies, MJ; Gavin, JR; Meininger, G; Vijapurkar, U, 2015
)
1.05
"Treatment with canagliflozin was effective and generally well tolerated in both women (and men) with T2DM."( Benefits/risks of sodium-glucose co-transporter 2 inhibitor canagliflozin in women for the treatment of Type 2 diabetes.
Kushner, P, 2016
)
1.02
"Treatment with canagliflozin significantly decreased adiposity and levels of fasting glucose and HbA1c but increased average serum FABP4 level by 10.3% (18.0 ± 1.0 vs."( Possible Increase in Serum FABP4 Level Despite Adiposity Reduction by Canagliflozin, an SGLT2 Inhibitor.
Furuhashi, M; Hiramitsu, S; Ishii, J; Matsumoto, M; Miura, T; Moniwa, N; Omori, A; Tanaka, M; Yoshida, H, 2016
)
1.01
"Oral treatment with canagliflozin and TA-1887 also enhanced glucose-induced aGLP-1 elevation when co-administered with either teneligliptin or sitagliptin."( Changes in glucose-induced plasma active glucagon-like peptide-1 levels by co-administration of sodium-glucose cotransporter inhibitors with dipeptidyl peptidase-4 inhibitors in rodents.
Arakawa, K; Hikida, K; Kuriyama, C; Matsushita, Y; Minami, M; Nakayama, K; Oguma, T; Saito, A; Shiotani, M; Tsuda-Tsukimoto, M; Ueta, K, 2016
)
0.75

Toxicity

Canagliflozin was generally safe and well tolerated. Higher incidences of genital mycotic infections and osmotic diuresis-related adverse events (AEs) were seen with canaglif lozin compared with placebo.

ExcerptReferenceRelevance
" Adverse events (AEs) were recorded throughout the study."( Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise.
Alba, M; Canovatchel, W; Cefalu, WT; Kim, KA; Meininger, G; Stenlöf, K; Tong, C; Usiskin, K, 2013
)
0.7
" Safety was assessed based on adverse event (AE) reports; renal safety parameters (e."( Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease.
Bakris, G; Cariou, B; David-Neto, E; Figueroa, K; Meininger, G; Usiskin, K; Wajs, E; Xi, L; Yale, JF; Yue, D, 2013
)
0.7
" Adverse events (AEs) were reported throughout the study."( Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial.
Bode, B; Fung, A; Stenlöf, K; Sullivan, D; Usiskin, K, 2013
)
0.7
"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
" The safety assessments included adverse events (AEs) and clinical laboratory tests."( Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, 12-week study.
Inagaki, N; Kondo, K; Kuki, H; Maruyama, N; Susuta, Y; Yoshinari, T, 2013
)
0.7
" 39 (8%) patients had serious adverse events in the glimepiride group versus 24 (5%) in the canagliflozin 100 mg group and 26 (5%) in the 300 mg group."( Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial.
Arias, P; Balis, DA; Canovatchel, W; Cefalu, WT; Leiter, LA; Meininger, G; Niskanen, L; Xie, J; Yoon, KH, 2013
)
0.92
" Adverse events (AEs) were recorded throughout the study."( Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial.
Canovatchel, W; Davidson, J; Januszewicz, A; Lavalle-González, FJ; Meininger, G; Qiu, R; Tong, C, 2013
)
0.7
" Adverse events (AEs) were recorded throughout the study."( Long-term efficacy and safety of canagliflozin monotherapy in patients with type 2 diabetes inadequately controlled with diet and exercise: findings from the 52-week CANTATA-M study.
Alba, M; Canovatchel, W; Cefalu, WT; Edwards, R; Jodar, E; Kim, KA; Meininger, G; Stenlöf, K; Tong, C, 2014
)
0.68
" Overall adverse event (AE) rates were similar across groups over 52 weeks, with higher rates of genital mycotic infections and osmotic diuresis-related AEs seen with canagliflozin vs."( Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial.
Black, S; Canovatchel, W; Charpentier, G; González-Gálvez, G; Hollander, P; Law, G; Mathieu, C; Meininger, G; Usiskin, K; Vercruysse, F; Wilding, JP, 2013
)
0.9
" The most common adverse effects are genital mycotic infections occurring in 11-15% of women exposed to canagliflozin versus 2-4% of those randomized to glimepiride or sitagliptin."( Safety of canagliflozin in patients with type 2 diabetes.
Mikhail, N, 2014
)
1.02
" Overall adverse event (AE) incidence over 52 weeks was 69."( Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes on background metformin and pioglitazone.
Forst, T; Goldenberg, R; Guthrie, R; Meininger, G; Stein, P; Vijapurkar, U; Yee, J, 2014
)
0.71
" Assessment of safety/tolerability included adverse event (AE) reports, incidence of documented hypoglycaemia, and percent change from baseline in fasting plasma lipids."( Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies.
Bode, B; Desai, M; Fung, A; Harris, S; Mayer, C; Meininger, G; Shaw, W; Sinclair, A; Usiskin, K; Vijapurkar, U, 2014
)
0.71
" Adverse effects such as increased urinary frequency, genital mycotic infections, and urinary tract infections may discourage the use of CAN in the elderly patient."( A review of the efficacy and safety of canagliflozin in elderly patients with type 2 diabetes.
Baggett, S; Elmore, LK; Kyle, JA; Skelley, JW, 2014
)
0.67
" Safety/tolerability evaluations included adverse event (AE) reporting, with additional data collection prespecified for selected AEs, and assessments of renal-related, lipid, and other safety laboratory parameters."( Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results.
Fung, A; Kline, I; Mayer, C; Meininger, G; Usiskin, K, 2014
)
0.7
" Efficacy endpoints included changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight and systolic blood pressure (BP); adverse events (AEs) were also recorded."( Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes mellitus and chronic kidney disease.
Bakris, G; Cariou, B; David-Neto, E; Figueroa, K; Jiang, J; Law, G; Meininger, G; Nieto, J; Usiskin, K; Wajs, E; Yale, JF; Yue, D, 2014
)
0.71
" The most common adverse events with canagliflozin included genital mycotic infections and adverse events related to reduced intravascular volume likely secondary to osmotic diuresis."( Efficacy and safety of canagliflozin in patients with type 2 diabetes and stage 3 nephropathy.
Bakris, G; Davies, M; de Zeeuw, D; Kline, I; Mayer, C; Meininger, G; Perkovic, V; Usiskin, K; Vijapurkar, U; Woo, V; Yamout, H, 2014
)
0.99
" Common adverse effects including genital tract infections and osmotic diuresis-related AEs were identified and reviewed."( Efficacy and safety of canagliflozin in subjects with type 2 diabetes: systematic review and meta-analysis.
Huang, YL; Lai, D; Shen, HP; Yang, XP; Zhong, XY, 2014
)
0.71
"The effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure (BP) and osmotic diuresis- and intravascular volume reduction-related adverse events (AEs) were evaluated using pooled data from four placebo-controlled, phase 3 studies in patients with type 2 diabetes mellitus (T2DM; N=2313)."( Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus.
Fung, A; Gilbert, RE; Januszewicz, A; Kline, I; Meininger, G; Vijapurkar, U; Weir, MR, 2014
)
1.16
" The main adverse effects likely to be seen are a very small increase in risk of urinary tract infections and a modest risk of developing genital fungal infections."( A safety evaluation of canagliflozin : a first-in-class treatment for type 2 diabetes.
Boyle, LD; Wilding, JP, 2014
)
0.71
" Safety was assessed by adverse event (AE) reports."( Long-term efficacy and safety of canagliflozin over 104 weeks in patients aged 55-80 years with type 2 diabetes.
Bode, B; Fung, A; Harris, S; Meininger, G; Stenlöf, K; Sullivan, D; Usiskin, K, 2015
)
0.7
" No deaths, hypoglycemic events, or discontinuations due to adverse events were observed."( Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Canagliflozin in Healthy Chinese Subjects.
Chen, X; Curtin, CR; Devineni, D; Hu, P; Polidori, D; Sha, S; Stieltjes, H; Vaccaro, N; Weiner, S, 2015
)
0.66
" Canagliflozin was generally safe and well tolerated in these healthy Chinese subjects."( Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Canagliflozin in Healthy Chinese Subjects.
Chen, X; Curtin, CR; Devineni, D; Hu, P; Polidori, D; Sha, S; Stieltjes, H; Vaccaro, N; Weiner, S, 2015
)
1.57
" Safety/tolerability evaluation included reporting of general and prespecified adverse events (AEs)."( The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus.
Alba, M; Davies, M; Davies, MJ; Gavin, JR; Meininger, G; Vijapurkar, U, 2015
)
0.71
" Canagliflozin was generally safe and well tolerated."( The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus.
Alba, M; Davies, M; Davies, MJ; Gavin, JR; Meininger, G; Vijapurkar, U, 2015
)
1.62
" Safety was evaluated on the basis of adverse event (AE) reports, blood and urine laboratory parameters, and vital signs."( Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus.
Iijima, H; Inagaki, N; Kifuji, T; Maruyama, N, 2015
)
0.67
" Higher incidences of genital mycotic infections and osmotic diuresis-related adverse events (AEs) were seen with canagliflozin compared with placebo."( Efficacy and safety of canagliflozin when used in conjunction with incretin-mimetic therapy in patients with type 2 diabetes.
Capuano, G; de Zeeuw, D; Desai, M; Fulcher, G; Mahaffey, KW; Mathieu, C; Matthews, DR; Meininger, G; Neal, B; Perkovic, V; Shaw, W; Vercruysse, F; Woo, V; Wysham, C, 2016
)
0.96
" Safety was assessed by adverse event (AE) reports."( Efficacy and Safety of Canagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, as Add-on to Insulin in Patients With Type 1 Diabetes.
Alba, M; Henry, RR; Polidori, D; Thakkar, P; Tong, C, 2015
)
0.73
" The effects of canagliflozin on the incidence of adverse events (AEs), BP, and LDL-C were evaluated."( Effects of Baseline Blood Pressure and Low-Density Lipoprotein Cholesterol on Safety and Efficacy of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus.
Goda, M; Iijima, H; Inagaki, N; Maruyama, N; Yokota, S, 2015
)
0.98
" Safety was assessed based on adverse event (AE) reports."( Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America.
Alba, M; Cerdas, S; Chacon, Mdel P; Eliaschewitz, FG; Lavalle-González, FJ; Tong, C, 2016
)
0.74
" Some manageable adverse events include genital mycotic infections, urinary tract infections, osmotic diuresis-related events etc."( Efficacy and safety of canagliflozin in type 2 diabetes mellitus: systematic review of randomized controlled trials.
Agarwal, NB; Kaushal, N; Mali, G; Parveen, R; Raisuddin, S, 2016
)
0.74
" Safety was assessed based on adverse event (AE) reports from eight randomized, double-blind, placebo- and active-controlled studies (N = 9,439; n = 8,949 aged <75, n = 490 aged ≥75)."( Efficacy and Safety of Canagliflozin in Individuals Aged 75 and Older with Type 2 Diabetes Mellitus: A Pooled Analysis.
Bode, B; Desai, M; Harris, S; Meininger, G; Shaw, W; Sinclair, AJ; Vijapurkar, U, 2016
)
0.74
" Safety was assessed by reports of adverse events."( Impact of Age and Estimated Glomerular Filtration Rate on the Glycemic Efficacy and Safety of Canagliflozin: A Pooled Analysis of Clinical Studies.
Desai, M; Fioretto, P; Gilbert, RE; Kline, I; Law, G; Meininger, G; Shaw, W; Weir, MR, 2016
)
0.65
" The overall incidence of adverse events was similar across treatment groups regardless of sex, baseline BMI, baseline age or baseline eGFR."( Impact of Age and Estimated Glomerular Filtration Rate on the Glycemic Efficacy and Safety of Canagliflozin: A Pooled Analysis of Clinical Studies.
Desai, M; Fioretto, P; Gilbert, RE; Kline, I; Law, G; Meininger, G; Shaw, W; Weir, MR, 2016
)
0.65
"Efficacy endpoints included change from baseline in HbA1c, body weight (BW), systolic blood pressure (SBP), and lipids at week 26; safety and tolerability were assessed by adverse event reports."( Efficacy and Safety of Canagliflozin in Type 2 Diabetes Patients of Different Ethnicity.
Aguilar, R; Alba, M; Davidson, JA; Lavalle González, FJ; Meininger, G; Trujillo, A; Vijapurkar, U, 2016
)
0.74
"6 mmol/l (≥100 mg/dl); and no volume depletion-related adverse events (AEs) within 2 weeks before dose increase."( Efficacy and safety of titrated canagliflozin in patients with type 2 diabetes mellitus inadequately controlled on metformin and sitagliptin.
Aggarwal, N; Alba, M; Cao, A; Fung, A; Pfeifer, M; Rodbard, HW; Seufert, J, 2016
)
0.72
" The overall incidence of adverse events was similar between the two groups."( Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus.
Goda, M; Harashima, S; Iijima, H; Inagaki, N; Kawaguchi, Y; Maruyama, N, 2016
)
0.74
"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
" The overall safety of canagliflozin was good, with the exception of high incidence of genital mycotic infections and osmotic diuresis-related adverse events."( Efficacy and safety of canagliflozin in patients with type 2 diabetes: A meta-analysis of randomized controlled trials.
Chang, F; Xiao, MY; Xiong, W; Zhang, M, 2016
)
1.06
" Safety was assessed based on adverse event (AE) reports, including the incidence of AEs related to the mechanism of SGLT2 inhibition."( Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis.
Balis, D; Davies, MJ; Desai, M; Meininger, G; Qiu, R; Xie, J, 2017
)
0.72
"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
)
1.05
" Other endpoints included changes in fasting plasma glucose, body weight, proinsulin/C-peptide ratio, homeostatic model assessment 2-%B and adverse events."( Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24-week, randomized, double-blind, placebo-controlled trial.
Gouda, M; Iijima, H; Inagaki, N; Kadowaki, T; Kaneko, G; Kondo, K; Maruyama, N; Nakanishi, N; Nishimura, K; Watanabe, Y, 2017
)
0.77
" Safety was assessed based on adverse event (AE) reports."( Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data.
Davies, MJ; Merton, K; Qiu, R; Vijapurkar, U; Yee, J, 2017
)
0.77
" The safety endpoint was the incidence of adverse events (AEs)."( Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes.
Gouda, M; Iijima, H; Inagaki, N; Kadowaki, T; Kaneko, G; Kondo, K; Maruyama, N; Nakanishi, N; Nishimura, K; Watanabe, Y, 2018
)
0.76
" The incidence of adverse events was similar in both groups (55."( Efficacy and safety of teneligliptin added to canagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, placebo-controlled, parallel-group comparative study.
Gouda, M; Iijima, H; Inagaki, N; Kadowaki, T; Kaneko, G; Kondo, K; Maruyama, N; Nakanishi, N; Nishimura, K; Watanabe, Y, 2018
)
0.74
" The main outcomes included the incidences of adverse drug reactions (ADRs), serious ADRs, and the changes of laboratory tests as well as efficacy variables."( Safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus: a 1-year post-marketing surveillance in Japan.
Goda, M; Sasaki, K; Tajima, T; Ueno, M; Yamakura, T, 2018
)
0.79
" The safety endpoints were adverse events, hypoglycaemic events, and laboratory test values."( Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus.
Harashima, SI; Iijima, H; Inagaki, N; Kaku, K; Kawaguchi, Y; Kondo, K; Maruyama, N; Otsuka, M, 2018
)
0.76
" Adverse events occurred in 85."( Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus.
Harashima, SI; Iijima, H; Inagaki, N; Kaku, K; Kawaguchi, Y; Kondo, K; Maruyama, N; Otsuka, M, 2018
)
0.76
" 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
)
2.26
" Safety endpoints included adverse events (AEs), hypoglycaemia and laboratory tests."( Efficacy and safety of canagliflozin as add-on therapy to a glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week, open-label, phase IV study.
Harashima, SI; Inagaki, N; Kawaguchi, Y; Kondo, K; Maruyama, N; Otsuka, M; Watanabe, Y, 2018
)
0.79
"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
" 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
" Whereas, several adverse events caused by SGLT2is were also reported."( Investigation of efficacy and safety of low-dose sodium glucose transporter 2 inhibitors and differences between two agents, canagliflozin and ipragliflozin, in patients with type 2 diabetes mellitus.
Abe, I; Abe, M; Fujii, H; Kobayashi, K; Kudo, T; Minezaki, M; Mukoubara, S; Ochi, K; Ohe, K; Ohishi, H; Ohnishi, Y; Shinagawa, T; Sugimoto, K; Takashi, Y; Yamao, Y, 2019
)
0.72
" A total of 9 adverse events were reported including 2 episodes of urinary tract infection (UTI) and 4 episodes of genital infection."( Real world study of short term efficacy, safety, and tolerability of canagliflozin 100 mg initiation in type 2 diabetes mellitus patients during hot humid Indian summer.
Ghosh, S; Majumder, A; Pandit, K; Sanyal, D,
)
0.37
" This analysis of CREDENCE trial data examines the effect of canagliflozin on the incidence of kidney-related adverse events (AEs)."( Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the Randomized CREDENCE Trial.
Agarwal, R; Capuano, G; Charytan, DM; Craig, J; de Zeeuw, D; Di Tanna, GL; Heerspink, HJL; Jardine, MJ; Levin, A; Li, J; Neal, B; Oshima, M; Perkovic, V; Wheeler, DC; Yavin, Y; Zhang, H, 2022
)
2.41
" These results highlight the safety of canagliflozin with regard to adverse kidney-related AEs."( Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the Randomized CREDENCE Trial.
Agarwal, R; Capuano, G; Charytan, DM; Craig, J; de Zeeuw, D; Di Tanna, GL; Heerspink, HJL; Jardine, MJ; Levin, A; Li, J; Neal, B; Oshima, M; Perkovic, V; Wheeler, DC; Yavin, Y; Zhang, H, 2022
)
2.43
"Clinical trials are often underpowered to detect serious but rare adverse events of a new medication."( A novel data mining application to detect safety signals for newly approved medications in routine care of patients with diabetes.
Fralick, M; Kulldorff, M; Patorno, E; Redelmeier, D; Schneeweiss, S; Vine, S; Wang, SV, 2021
)
0.62
" We screened for incident adverse events where there were more outcomes observed among canagliflozin vs."( A novel data mining application to detect safety signals for newly approved medications in routine care of patients with diabetes.
Fralick, M; Kulldorff, M; Patorno, E; Redelmeier, D; Schneeweiss, S; Vine, S; Wang, SV, 2021
)
0.84
"In a large population-based study, we identified known but no other adverse events associated with canagliflozin, providing reassurance on its safety among adult patients with T2D and suggesting the tree-based scan statistic method is a useful post-marketing safety monitoring tool for newly approved medications."( A novel data mining application to detect safety signals for newly approved medications in routine care of patients with diabetes.
Fralick, M; Kulldorff, M; Patorno, E; Redelmeier, D; Schneeweiss, S; Vine, S; Wang, SV, 2021
)
0.84
" Safety was evaluated in terms of adverse drug reactions (ADRs)."( Real-World Safety and Effectiveness of Canagliflozin Treatment for Type 2 Diabetes Mellitus in Japan: SAPPHIRE, a Long-Term, Large-Scale Post-Marketing Surveillance.
Hamada, K; Inagaki, N; Iwasaki, T; Mori-Anai, K; Nangaku, M; Sakata, Y; Sasaki, K, 2022
)
0.99
" Adverse drug reactions occurred in 10."( Real-World Safety and Effectiveness of Canagliflozin Treatment for Type 2 Diabetes Mellitus in Japan: SAPPHIRE, a Long-Term, Large-Scale Post-Marketing Surveillance.
Hamada, K; Inagaki, N; Iwasaki, T; Mori-Anai, K; Nangaku, M; Sakata, Y; Sasaki, K, 2022
)
0.99
" Compared with controls, empagliflozin 10 mg and 25 mg, and canagliflozin 100 mg reduced the risk of any adverse events while canagliflozin 100 mg reduced the risk of serious adverse events."( Renal protective effect and safety of sodium-glucose cotransporter-2 inhibitors in patients with chronic kidney disease and type 2 diabetes mellitus: a network meta-analysis and systematic review.
Lin, J; Wang, S; Wen, T; Zhang, X, 2022
)
0.96
"5%) discontinued treatment due to adverse events which were SGLT2i related."( SGLT2-inhibitors are effective and safe in the elderly: The SOLD study.
Berra, C; Bertuzzi, F; Betella, N; Bucciarelli, L; Bulgheroni, M; Cimino, V; Favacchio, G; Fiorina, P; Folli, F; Gandolfi, A; Girelli, A; Lunati, ME; Luzi, L; Mascardi, C; Massari, G; Mirani, M; Montefusco, L; Morpurgo, PS; Pace, C; Pastore, I; Pintaudi, B; Trevisan, M, 2022
)
0.72
"SGLT2i are well-tolerated and safe in the elderly and appear as an effective therapeutic option, though some caution is also suggested, especially in more fragile subjects."( SGLT2-inhibitors are effective and safe in the elderly: The SOLD study.
Berra, C; Bertuzzi, F; Betella, N; Bucciarelli, L; Bulgheroni, M; Cimino, V; Favacchio, G; Fiorina, P; Folli, F; Gandolfi, A; Girelli, A; Lunati, ME; Luzi, L; Mascardi, C; Massari, G; Mirani, M; Montefusco, L; Morpurgo, PS; Pace, C; Pastore, I; Pintaudi, B; Trevisan, M, 2022
)
0.72
" Canagliflozin has one reported major degradation product, also metformin hydrochloride has one reported major degradation product, cyanoguanidine, and has a potential toxic impurity, melamine, that is reported to cause crystalluria that causes chronic kidney inflammation and nephrolithiasis leading to a renal failure."( Ecofriendly appraisal of stability-indicating high-performance chromatographic assay of canagliflozin and metformin with their toxic impurities; in silico toxicity prediction.
Emam, AA; Emam, RA, 2023
)
2.04

Pharmacokinetics

No changes in AUC0 - 72h and Cmax were observed for canagliflozin+teneligliptin versus monotherapy. Tmax and t½ of canag liflozin were independent of the dose. The half-life of orally administered canag Liflozin 100 or 300mg in healthy partici

ExcerptReferenceRelevance
" Half-life and time at which Cmax was observed were dose-independent."( Pharmacokinetics and pharmacodynamics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in subjects with type 2 diabetes mellitus.
Curtin, CR; Devineni, D; Gutierrez, MJ; Murphy, J; Polidori, D; Rothenberg, PL; Rusch, S, 2013
)
0.66
"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
"This study evaluated the effects of HCTZ on the pharmacokinetic and pharmacodynamic properties and tolerability of canagliflozin in healthy participants."( Effects of hydrochlorothiazide on the pharmacokinetics, pharmacodynamics, and tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in healthy participants.
Devineni, D; Polidori, D; Rusch, S; Vaccaro, N; Wajs, E, 2014
)
0.83
" Blood samples were taken before and several times after administration on day 7 of period 1 and on days 28 and 35 of period 2 for canagliflozin and HCTZ pharmacokinetic analyses using LC-MS/MS."( Effects of hydrochlorothiazide on the pharmacokinetics, pharmacodynamics, and tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in healthy participants.
Devineni, D; Polidori, D; Rusch, S; Vaccaro, N; Wajs, E, 2014
)
0.83
"Adding canagliflozin treatment to healthy participants on HCTZ treatment had no notable pharmacokinetic or pharmacodynamic effects; canagliflozin coadministered with HCTZ was generally well tolerated, with no unexpected tolerability concerns."( Effects of hydrochlorothiazide on the pharmacokinetics, pharmacodynamics, and tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in healthy participants.
Devineni, D; Polidori, D; Rusch, S; Vaccaro, N; Wajs, E, 2014
)
1.08
" Pharmacodynamic parameters were assessed at baseline and at weeks 1 and 12."( Effect of the sodium glucose co-transporter 2 inhibitor canagliflozin on plasma volume in patients with type 2 diabetes mellitus.
Farrell, K; Heise, T; Natarajan, J; Plum-Mörschel, L; Polidori, D; Rothenberg, P; Sha, S; Sica, D; Wang, SS, 2014
)
0.65
"This randomized, double-blind, placebo-controlled, single and multiple ascending-dose study evaluated the pharmacodynamic effects and safety/tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes."( Pharmacodynamic effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, from a randomized study in patients with type 2 diabetes.
Arnolds, S; Demarest, K; Devineni, D; Ghosh, A; Hompesch, M; Morrow, L; Polidori, D; Rothenberg, P; Sha, S; Spitzer, H, 2014
)
0.9
"This randomized, double-blind, placebo-controlled, single and multiple ascending-dose study evaluated the pharmacodynamic effects and safety/tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes."( Pharmacodynamic effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, from a randomized study in patients with type 2 diabetes.
Arnolds, S; Demarest, K; Devineni, D; Ghosh, A; Hompesch, M; Morrow, L; Polidori, D; Rothenberg, P; Sha, S; Spitzer, H, 2014
)
0.9
" Probenecid increased the Cmax by 13% and the AUC by 21%."( Effects of rifampin, cyclosporine A, and probenecid on the pharmacokinetic profile of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in healthy participants.
Ariyawansa, J; Curtin, C; Devineni, D; Di Prospero, NA; Mamidi, RN; Murphy, J; Rothenberg, P; Stieltjes, H; Vaccaro, N; Wajs, E; Wang, SS; Weiner, S, 2015
)
0.64
"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
)
0.9
" 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
" Similarly, pharmacodynamic effects of canagliflozin on RTG and UGE were found to be dose- and concentration-dependent."( Single- and multiple-dose pharmacokinetics and pharmacodynamics of canagliflozin, a selective inhibitor of sodium glucose co-transporter 2, in healthy participants.
Devineni, D; Polidori, D; Stieltjes, H; Vaccaro, N; Wajs, E, 2015
)
0.92
"When comparing the IR FDC tablet administered with and without food, PK parameters of canagliflozin were bioequivalent as the 90% confidence intervals (CIs) for log-transformed AUClast, AUC∞, and Cmax were within the bioequivalence limits of 80-125%."( Effect of food on the pharmacokinetics of canagliflozin/metformin (150/1,000 mg) immediate-release fixed-dose combination tablet in healthy participants.
Devineni, D; Murphy, J; Stieltjes, H; Wajs, E; Wang, SS, 2015
)
0.9
" The Cmax of metformin was decreased by 16%, which is not considered clinically meaningful."( Effect of food on the pharmacokinetics of canagliflozin/metformin (150/1,000 mg) immediate-release fixed-dose combination tablet in healthy participants.
Devineni, D; Murphy, J; Stieltjes, H; Wajs, E; Wang, SS, 2015
)
0.68
" In the renal study, the mean Cmax values were 13%, 29%, and 29% higher and the mean AUC0-∞ values were 17%, 63%, and 50% higher in participants with mild, moderate, and severe renal impairment, respectively; values were similar in the ESRD group relative to the group with normal function, however."( Effect of hepatic or renal impairment on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor.
Curtin, CR; Devineni, D; Marbury, TC; Rusch, S; Smith, W; Stieltjes, H; Vaccaro, N; Vandebosch, A; Wajs, E; Wexler, D, 2015
)
0.65
" Pharmacodynamic response to canagliflozin, measured by using UGE and RTG, declined with increasing severity of renal impairment."( Effect of hepatic or renal impairment on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor.
Curtin, CR; Devineni, D; Marbury, TC; Rusch, S; Smith, W; Stieltjes, H; Vaccaro, N; Vandebosch, A; Wajs, E; Wexler, D, 2015
)
0.95
" 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
" The pharmacokinetic findings in participants carrying the UGT1A9*3 and UGT2B4*2 allele implicate that UGT1A9 and UGT2B4 are involved in the metabolism of canagliflozin to M7 and M5, respectively."( In vitro metabolism of canagliflozin in human liver, kidney, intestine microsomes, and recombinant uridine diphosphate glucuronosyltransferases (UGT) and the effect of genetic variability of UGT enzymes on the pharmacokinetics of canagliflozin in humans.
Devineni, D; Favis, R; Francke, S; Jadwin, A; Mamidi, RN; Scheers, E; Solanki, B, 2015
)
0.93
" Median tmax and mean t1/2 were independent of dose and regimen."( Pharmacokinetics and pharmacodynamics of once- and twice-daily multiple-doses of canagliflozin, a selective inhibitor of sodium glucose co-transporter 2, in healthy participants.
Curtin, CR; Devineni, D; Murphy, J; Polidori, D; Stieltjes, H; Wajs, E; Wang, SS, 2015
)
0.64
" The half-life of orally administered canagliflozin 100 or 300 mg in healthy participants is 10."( Clinical Pharmacokinetic, Pharmacodynamic, and Drug-Drug Interaction Profile of Canagliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor.
Devineni, D; Polidori, D, 2015
)
0.92
" Mean AUC and Cmax of canagliflozin increased in a dose-dependent manner after single-dose administration (AUC0-∞, 10,521 ng · h/mL for 100 mg, 33,583 ng · h/mL for 300 mg; Cmax, 1178 ng/mL for 100 mg, 4113 ng/mL for 300 mg)."( Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Canagliflozin in Healthy Chinese Subjects.
Chen, X; Curtin, CR; Devineni, D; Hu, P; Polidori, D; Sha, S; Stieltjes, H; Vaccaro, N; Weiner, S, 2015
)
0.97
" Tmax and t½ of canagliflozin were independent of the dose."( Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Canagliflozin in Healthy Chinese Subjects.
Chen, X; Curtin, CR; Devineni, D; Hu, P; Polidori, D; Sha, S; Stieltjes, H; Vaccaro, N; Weiner, S, 2015
)
1
"The computational effort required to fit the pharmacodynamic (PD) part of a pharmacokinetic/pharmacodynamic (PK/PD) model can be considerable if the differential equations describing the model are solved numerically."( The method of averaging applied to pharmacokinetic/pharmacodynamic indirect response models.
de Winter, W; Dunne, A; Hsu, CH; Mariam, S; Neyens, M; Pinheiro, J; Woot de Trixhe, X, 2015
)
0.42
"0 h and elimination half-life (t 1/2) of 10."( Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus.
Iijima, H; Inagaki, N; Kifuji, T; Maruyama, N, 2015
)
0.67
" A population pharmacokinetic (popPK) model of canagliflozin, including relevant covariates as sources of inter-individual variability, was developed to describe phase I, II, and III data in healthy volunteers and in patients with type 2 diabetes mellitus (T2DM)."( Population Pharmacokinetic Modeling of Canagliflozin in Healthy Volunteers and Patients with Type 2 Diabetes Mellitus.
De Winter, W; Devineni, D; Dunne, A; Hoeben, E; Neyens, M; Vermeulen, A, 2016
)
0.96
" This study assessed the pharmacokinetic (PK) and pharmacodynamic (PD) properties and tolerability of single-dose canagliflozin 200 or 300 mg in healthy Indian participants."( Single-dose Pharmacokinetics and Pharmacodynamics of Canagliflozin, a Selective Inhibitor of Sodium Glucose Cotransporter 2, in Healthy Indian Participants.
Curtin, C; Devineni, D; Polidori, D; Stieltjes, H; Tian, H; Wajs, E, 2016
)
0.89
" After the administration of single doses of 200 and 300 mg, the mean (SD) Cmax values were 1792 (430) ng/mL and 2789 (941) ng/mL, respectively; AUC0-∞, values were 18,706 (3818) ng·h/mL and 28,207 (5901) ng·h/mL, respectively."( Single-dose Pharmacokinetics and Pharmacodynamics of Canagliflozin, a Selective Inhibitor of Sodium Glucose Cotransporter 2, in Healthy Indian Participants.
Curtin, C; Devineni, D; Polidori, D; Stieltjes, H; Tian, H; Wajs, E, 2016
)
0.68
" The Tmax and t½ of canagliflozin appeared to be independent of dose."( Single-dose Pharmacokinetics and Pharmacodynamics of Canagliflozin, a Selective Inhibitor of Sodium Glucose Cotransporter 2, in Healthy Indian Participants.
Curtin, C; Devineni, D; Polidori, D; Stieltjes, H; Tian, H; Wajs, E, 2016
)
1.01
" 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
"1 mL) was established and applied to a pharmacokinetic study in rats."( A validated LC-MS/MS method for the determination of canagliflozin, a sodium-glucose co-transporter 2 (SGLT-2) inhibitor, in a lower volume of rat plasma: application to pharmacokinetic studies in rats.
Ito, Y; Kobuchi, S; Sakaeda, T; Yano, K, 2016
)
0.68
"93) and Cmax (ratio: 108."( Effect of food on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, and assessment of dose proportionality in healthy participants.
Ariyawansa, J; Devineni, D; Di Prospero, NA; Manitpisitkul, P; Murphy, J; Rothenberg, P; Stieltjes, H, 2015
)
0.68
" Pharmacokinetic parameters were assessed at prespecified intervals."( Effect of canagliflozin on the pharmacokinetics of glyburide, metformin, and simvastatin in healthy participants.
Devineni, D; Mamidi, RN; Manitpisitkul, P; Murphy, J; Skee, D; Stieltjes, H; Tian, H; Usiskin, K; Vandebosch, A; Verhaeghe, T; Wajs, E; Wang, SS,
)
0.53
" Therefore, a physiologically based pharmacokinetic (PBPK) model of canagliflozin was developed based on clinical data from healthy volunteers and it was used to simulate luminal concentrations in intestines and renal tubules."( Physiologically based pharmacokinetic-pharmacodynamic modeling to predict concentrations and actions of sodium-dependent glucose transporter 2 inhibitor canagliflozin in human intestines and renal tubules.
Mori, K; Nakamaru, Y; Saito, R; Shimizu, M; Yamazaki, H, 2016
)
0.87
" A physiologically-based pharmacokinetic (PBPK) model was developed and clinical DDI simulations were performed to determine the likelihood of cytochrome P450 (CYP) inhibition by canagliflozin."( In vitro and physiologically-based pharmacokinetic based assessment of drug-drug interaction potential of canagliflozin.
Cuyckens, F; Dallas, S; Evans, DC; Johnson, MD; Kelley, MF; Leclercq, L; Lim, HK; Mamidi, RNVS; Scheers, E; Sensenhauser, C; Snoeys, J; Verboven, P, 2017
)
0.86
"This study was conducted to evaluate the pharmacokinetic properties and bioequivalence of two oral formulations of canagliflozin: a newly developed generic formulation (test) and a branded formulation (reference)."( Pharmacokinetics and bioequivalence of two oral formulations of canagliflozin after single-dose administration in healthy Chinese subjects
.
Hu, W; Liu, Z; Lu, C; Yang, Y; Zhang, Q; Zhou, R, 2020
)
1.01
"To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of rongliflozin in a cohort of healthy Chinese people and people with type 2 diabetes mellitus (T2DM)."( Pharmacokinetics and pharmacodynamics of rongliflozin, a novel selective inhibitor of sodium-glucose co-transporter-2, in people with type 2 diabetes mellitus.
Chen, H; Ding, Y; Li, C; Li, X; Liu, C; Liu, J; Wu, M; Zhang, H; Zhang, Y; Zhu, X, 2020
)
0.56
" This Phase I trial evaluated the pharmacokinetic and pharmacodynamic properties of DJT1116PG at steady state in healthy Chinese individuals."( A Phase I Study on the Pharmacokinetics and Pharmacodynamics of DJT1116PG, a Novel Selective Inhibitor of Sodium-glucose Cotransporter Type 2, in Healthy Individuals at Steady State.
Chen, H; Ding, Y; Li, C; Li, X; Liu, J; Wu, M; Zhang, H; Zhu, X, 2020
)
0.56
"A novel, selective and sensitive method is developed for simultaneous estimation of canagliflozin and metformin and successfully applied to fast and fed pharmacokinetic studies in healthy Indian volunteers."( Development of LC-MS/MS method for simultaneous determination of Canagliflozin and Metformin in human plasma and its pharmacokinetic application in Indian population under fast and fed conditions.
Gujar, S; Mungantiwar, A; Pandita, N; Wattamwar, T, 2020
)
1.02
" The main pharmacokinetic parameters were calculated using the non-compartmental model."( Evaluation of influence of telmisartan on the pharmacokinetics and tissue distribution of canagliflozin in rats and mice.
Ding, CY; Dong, ZJ; Li, Y; Meng, L; Wang, XN, 2021
)
0.84
"A pharmacokinetic drug-drug interaction between telmisartan and canagliflozin might occur during drug co-administration."( Evaluation of influence of telmisartan on the pharmacokinetics and tissue distribution of canagliflozin in rats and mice.
Ding, CY; Dong, ZJ; Li, Y; Meng, L; Wang, XN, 2021
)
1.08
" Here, we developed an ultra-performance liquid chromatography-tandem mass spectrometry method for the simultaneous determination of canagliflozin, sorafenib, and lenvatinib, and investigated the pharmacokinetic drug interactions between canagliflozin and sorafenib or lenvatinib in rats."( Pharmacokinetic Interactions between Canagliflozin and Sorafenib or Lenvatinib in Rats.
Cui, Y; Dong, Z; Guo, C; Li, Y; Ma, Y, 2022
)
1.2
" Tadalafil and canagliflozin were determined simultaneously in real human plasma using the described procedure and the method was applied for in vivo pharmacokinetic drug interaction study between the studied drugs, which proved significant interaction between them when administered simultaneously."( Cytochrome P450 3A4-mediated pharmacokinetic interaction study between tadalafil and canagliflozin using high-performance thin-layer chromatography.
Abdel-Aal, FAM; Ali, ABH; Mohamed, AI; Rageh, AH, 2022
)
1.3
" 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
)
1.36

Compound-Compound Interactions

meta-analysis of randomized control trials aimed to evaluate the effect of canagliflozin combined with other hypoglycemic drugs. Study demonstrates the long-term efficacy and safety of can Dagliflozin combined with insulin in Japanese patients.

ExcerptReferenceRelevance
"To evaluate the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin or metformin in combination with sulphonylurea."( Canagliflozin in Asian patients with type 2 diabetes on metformin alone or metformin in combination with sulphonylurea.
Dieu Van, NK; Han, P; Ji, L; Liu, Y; Meininger, G; Qiu, R; Vijapurkar, U; Yang, G, 2015
)
2.13
"Canagliflozin provided glycaemic improvements and reductions in body weight and systolic BP, and was generally well tolerated in Asian patients with T2DM on metformin or metformin in combination with sulphonylurea."( Canagliflozin in Asian patients with type 2 diabetes on metformin alone or metformin in combination with sulphonylurea.
Dieu Van, NK; Han, P; Ji, L; Liu, Y; Meininger, G; Qiu, R; Vijapurkar, U; Yang, G, 2015
)
3.3
" 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
)
0.66
"Canagliflozin in combination with insulin was effective in improving glycemic control and reducing body weight and well tolerated by Japanese patients with T2DM."( Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus.
Goda, M; Harashima, S; Iijima, H; Inagaki, N; Kawaguchi, Y; Maruyama, N, 2016
)
2.19
" This meta-analysis of randomized control trials aimed to evaluate the effect of canagliflozin combined with other hypoglycemic drugs."( Efficacy of canagliflozin combined with antidiabetic drugs in treating type 2 diabetes mellitus: Meta-analysis of randomized control trials.
Jiang, F; Liu, D; Meng, Q; Shen, Y, 2016
)
1.04
"gov for randomized control trials comparing canagliflozin combined with conventional antidiabetic drugs vs placebo."( Efficacy of canagliflozin combined with antidiabetic drugs in treating type 2 diabetes mellitus: Meta-analysis of randomized control trials.
Jiang, F; Liu, D; Meng, Q; Shen, Y, 2016
)
1.07
" The potential for canagliflozin to cause clinical drug-drug interactions (DDIs) was assessed."( In vitro and physiologically-based pharmacokinetic based assessment of drug-drug interaction potential of canagliflozin.
Cuyckens, F; Dallas, S; Evans, DC; Johnson, MD; Kelley, MF; Leclercq, L; Lim, HK; Mamidi, RNVS; Scheers, E; Sensenhauser, C; Snoeys, J; Verboven, P, 2017
)
1
"This study demonstrates the long-term efficacy and safety of canagliflozin combined with insulin in Japanese patients."( Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus.
Harashima, SI; Iijima, H; Inagaki, N; Kaku, K; Kawaguchi, Y; Kondo, K; Maruyama, N; Otsuka, M, 2018
)
1
"To analyze the efficacy and safety of replacing sitagliptin with canagliflozin in patients with type 2 diabetes (T2D) and poor metabolic control despite treatment with sitagliptin in combination with metformin and/or gliclazide."( Efficacy and safety of replacing sitagliptin with canagliflozin in real-world patients with type 2 diabetes uncontrolled with sitagliptin combined with metformin and/or gliclazide: The SITA-CANA Switch Study.
Garcia de Lucas, MD; Gómez Huelgas, R; Olalla Sierra, J; Pérez Belmonte, LM; Suárez Tembra, M, 2018
)
0.97
"5%) treated with sitagliptin in combination with metformin and/or gliclazide, sitagliptin (and gliclazide if appropriate) were replaced by canagliflozin."( Efficacy and safety of replacing sitagliptin with canagliflozin in real-world patients with type 2 diabetes uncontrolled with sitagliptin combined with metformin and/or gliclazide: The SITA-CANA Switch Study.
Garcia de Lucas, MD; Gómez Huelgas, R; Olalla Sierra, J; Pérez Belmonte, LM; Suárez Tembra, M, 2018
)
0.94
"In patients with T2D poorly controlled with sitagliptin, whether alone or in combination with metformin and/or gliclazide, replacing it with canagliflozin may be a simple yet effective intensification strategy."( Efficacy and safety of replacing sitagliptin with canagliflozin in real-world patients with type 2 diabetes uncontrolled with sitagliptin combined with metformin and/or gliclazide: The SITA-CANA Switch Study.
Garcia de Lucas, MD; Gómez Huelgas, R; Olalla Sierra, J; Pérez Belmonte, LM; Suárez Tembra, M, 2018
)
0.94
"Sodium-glucose cotransporter 2 inhibitor combined with dipeptidyl peptidase-4 inhibitor improved the quality of glycemic variability and reduced postprandial hyperglycemia compared with each monotherapy."( Improved time in range and postprandial hyperglycemia with canagliflozin in combination with teneligliptin: Secondary analyses of the CALMER study.
Aoki, S; Atsumi, T; Cho, KY; Kameda, H; Kawata, S; Kurihara, Y; Miya, A; Miyoshi, H; Nagai, S; Nakamura, A; Nishimoto, N; Nomoto, H; Omori, K; Shigesawa, I; Sugawara, H; Takeuchi, J; Taneda, S; Tsuchida, K; Yanagiya, S; Yokoyama, H, 2021
)
0.86
" We provide a comprehensive overview of the available pharmacological and clinical evidence on this potential drug-drug interaction (DDI)."( Potential drug-drug interaction between sodium-glucose co-transporter 2 inhibitors and statins: pharmacological and clinical evidence.
Douros, A; Kontogiorgis, C; Lalagkas, PN; Poulentzas, G, 2021
)
0.62
"Information on controlled trials was retrieved from four databases to obtain the effects of different doses of canagliflozin combined with metformin for treating T2DM."( Clinical Efficacy of Different Doses of Canagliflozin Combined with Metformin in the Treatment of Type 2 Diabetes: Meta-Analysis.
Li, G; Ni, J; Wang, S; Zhang, D, 2023
)
1.39
"The meta-analysis demonstrates that high doses of canagliflozin combined with metformin may be potentially effective in patients with T2DM, as evidenced by LS means of HbA1c and FPG, and the above conclusions need to be verified by more high-quality studies."( Clinical Efficacy of Different Doses of Canagliflozin Combined with Metformin in the Treatment of Type 2 Diabetes: Meta-Analysis.
Li, G; Ni, J; Wang, S; Zhang, D, 2023
)
1.43
" The diabetes drug canagliflozin inhibits NSCLC cell proliferation and the mammalian target of rapamycin (mTOR) pathway, which mediates cell growth and survival, but it is unclear whether this drug can enhance response rates when combined with cytotoxic therapy."( Canagliflozin mediates tumor suppression alone and in combination with radiotherapy in non-small cell lung cancer (NSCLC) through inhibition of HIF-1α.
Abdulkarim, B; Ahmadi, E; Ali, A; Berg, T; Biziotis, OD; Bramson, JL; Ellis, P; Farrell, T; Mekhaeil, B; Menjolian, G; Mesci, A; Muti, P; Singh, K; Steinberg, GR; Sur, RK; Tsakiridis, EE; Tsakiridis, T; Wang, S; Wu, J, 2023
)
2.68

Bioavailability

Canagliflozin (Invokana, JNJ-28431754) is an orally bioavailable and selective SGLT2 (subtype 2 sodium-glucose transport protein) inhibitor approved for the treatment of type 2 diabetes. Food did not affect canaglif lozin bioavailability parameters (Cmax and AUCs) or AUC's of metformin.

ExcerptReferenceRelevance
" Canagliflozin has dose-dependent pharmacokinetics, and research in laboratory animals demonstrated high oral bioavailability (85%) and rapid effects in lowering glycosylated hemoglobin (HbA(1c)) values."( Canagliflozin, a new sodium-glucose cotransporter 2 inhibitor, in the treatment of diabetes.
Kolanczyk, DM; Nisly, SA; Walton, AM, 2013
)
2.74
"Food did not affect canagliflozin bioavailability parameters (Cmax and AUCs) or AUCs of metformin."( Effect of food on the pharmacokinetics of canagliflozin/metformin (150/1,000 mg) immediate-release fixed-dose combination tablet in healthy participants.
Devineni, D; Murphy, J; Stieltjes, H; Wajs, E; Wang, SS, 2015
)
1
" Dose-proportional systemic exposure to canagliflozin has been observed over a wide dose range (50-1600 mg) with an oral bioavailability of 65 %."( Clinical Pharmacokinetic, Pharmacodynamic, and Drug-Drug Interaction Profile of Canagliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor.
Devineni, D; Polidori, D, 2015
)
0.91
" Sex, age, and weight on apparent volume of distribution of the central compartment, body mass index on first-order absorption rate constant, and body mass index and over-encapsulation on lag-time, and estimated glomerular filtration rate (eGFR, by MDRD equation), dose, and genetic polymorphism (carriers of UGT1A9*3 allele) on elimination rate constant were identified as statistically significant covariates."( Population Pharmacokinetic Modeling of Canagliflozin in Healthy Volunteers and Patients with Type 2 Diabetes Mellitus.
De Winter, W; Devineni, D; Dunne, A; Hoeben, E; Neyens, M; Vermeulen, A, 2016
)
0.7
"Absolute oral bioavailability of canagliflozin was assessed by simultaneous oral administration with intravenous [(14) C]-canagliflozin microdose infusion in nine healthy men."( Absolute oral bioavailability and pharmacokinetics of canagliflozin: A microdose study in healthy participants.
Devineni, D; Mamidi, RN; Murphy, J; Rothenberg, P; Scheers, E; Stieltjes, H; Wang, SS, 2015
)
0.95
"Canagliflozin (Invokana, JNJ-28431754) is an orally bioavailable and selective SGLT2 (subtype 2 sodium-glucose transport protein) inhibitor approved for the treatment of type 2 diabetes."( Syntheses of isotope-labeled SGLT2 inhibitor canagliflozin (JNJ-28431754).
Hoerr, DC; Lin, R; Salter, R; Weaner, LE, 2017
)
2.16
"The aim of the present investigation entails the development of solid SMEDDS for improving the oral bioavailability of canagliflozin using porous carriers."( Role of Porous Carriers in the Biopharmaceutical Performance of Solid SMEDDS of Canagliflozin.
Bedi, N; Singh, D; Tiwary, AK, 2018
)
0.92
" Enhanced in vitro dissolution rate of optimized solid SMEDDS manifested in bioavailability enhancement of 167."( Role of Porous Carriers in the Biopharmaceutical Performance of Solid SMEDDS of Canagliflozin.
Bedi, N; Singh, D; Tiwary, AK, 2018
)
0.71
"The present investigation reveals the immense potential of solid SMEDDS in augmenting the oral bioavailability profile of poorly water-soluble drug canagliflozin."( Role of Porous Carriers in the Biopharmaceutical Performance of Solid SMEDDS of Canagliflozin.
Bedi, N; Singh, D; Tiwary, AK, 2018
)
0.91
" The current study entails development and evaluation of spray dried lipid based formulation (solid SMEDDS) for enhancing oral bioavailability and anti-diabetic activity of CFZ."( Enhanced oral bioavailability and anti-diabetic activity of canagliflozin through a spray dried lipid based oral delivery: a novel paradigm.
Arora, S; Bedi, N; Kesavan, AK; Singh, AP; Singh, D; Tiwary, AK, 2020
)
0.8
" Graphical abstract Graphical Abstract: Enhanced oral bioavailability and anti-diabetic activity of canagliflozin through a spray dried lipid based oral delivery: a novel paradigm."( Enhanced oral bioavailability and anti-diabetic activity of canagliflozin through a spray dried lipid based oral delivery: a novel paradigm.
Arora, S; Bedi, N; Kesavan, AK; Singh, AP; Singh, D; Tiwary, AK, 2020
)
1.02
"The present investigation attempts to optimize Supersaturable lipid based formulation (SS SMEDDS) of Biopharmaceutical Classification System (BCS) class IV drug canagliflozin (CFZ) and evaluating the oral bioavailability of the formulation."( Polymeric Precipitation Inhibitor Based Supersaturable Self-microemulsifying Drug Delivery System of Canagliflozin: Optimization and Evaluation.
Bedi, N; Kang, TS; Singh, D; Tiwary, AK, 2021
)
1.03
" Canagliflozin reduced NADPH oxidase activity via AMP kinase (AMPK)/Rac1signalling and improved NOS coupling via increased tetrahydrobiopterin bioavailability ex vivo and in vitro."( Effects of canagliflozin on human myocardial redox signalling: clinical implications.
Akawi, N; Akoumianakis, I; Antoniades, C; Antonopoulos, AS; Badi, I; Carena, MC; Casadei, B; Channon, KM; Chuaiphichai, S; Farid, S; Kondo, H; Kotanidis, CP; Krasopoulos, G; Oikonomou, EK; Polkinghorne, M; Reus, EM; Sayeed, R; Shirodaria, C; Sommariva, E; Srivastava, V; Stadiotti, I, 2021
)
1.92
" The purpose of this study is to transform the structure of berberine in order to improve the bioavailability of berberine and reduce the dosage."( Synthesis of Berberine and Canagliflozin Chimera and Investigation into New Antibacterial Activity and Mechanisms.
Che, S; Chen, Y; Hao, W; Li, J; Luo, J; Wei, H; Xie, W; Zhang, W; Zhao, Z, 2022
)
1.02
" Commercially available CFZ tablets' active pharmaceutical ingredient (API) was Hemi-CFZ, which was easy conversion to CFZ or Mono-CFZ under the influence of temperature, pressure, humidity and other factors in tablets processing, storage, and transportation, thus affected bioavailability and efficacy of tablets."( Quantitative analysis of low content polymorphic impurities in canagliflozin tablets by PXRD, NIR, ATR-FITR and Raman solid-state analysis techniques combined with stoichiometry.
Gong, J; Li, H; Liu, J; Liu, M; Song, P; Wang, Q; Wu, S, 2023
)
1.15

Dosage Studied

Canagliflozin 300mg lowered HbA1c better than GLP-1RAs. Weight and SBP lowering could be non-inferior or slightly better with the latter drug.

ExcerptRelevanceReference
" The observed pharmacokinetic/pharmacodynamic profile of canagliflozin in subjects with type 2 diabetes supports a once-daily dosing regimen."( Pharmacokinetics and pharmacodynamics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in subjects with type 2 diabetes mellitus.
Curtin, CR; Devineni, D; Gutierrez, MJ; Murphy, J; Polidori, D; Rothenberg, PL; Rusch, S, 2013
)
0.9
"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
" The pharmacodynamic response to canagliflozin declines with increasing severity of renal impairment, and prescribing information should be consulted regarding dosage adjustments or restrictions in moderate to severe renal dysfunction."( Canagliflozin: a review of its use in patients with type 2 diabetes mellitus.
Plosker, GL, 2014
)
2.13
" 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
"Canagliflozin increased UGE dose-dependently (∼80-120 g/day with canagliflozin ≥100 mg), with increases maintained over the 14-day dosing period with each dose."( Pharmacodynamic effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, from a randomized study in patients with type 2 diabetes.
Arnolds, S; Demarest, K; Devineni, D; Ghosh, A; Hompesch, M; Morrow, L; Polidori, D; Rothenberg, P; Sha, S; Spitzer, H, 2014
)
2.14
"Canagliflozin increased UGE dose-dependently (,80-120 g/day with canagliflozin $100 mg), with increases maintained over the 14-day dosing period with each dose."( Pharmacodynamic effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, from a randomized study in patients with type 2 diabetes.
Arnolds, S; Demarest, K; Devineni, D; Ghosh, A; Hompesch, M; Morrow, L; Polidori, D; Rothenberg, P; Sha, S; Spitzer, H, 2014
)
2.14
" The focus of this article is to highlight the FDA's quantitative clinical pharmacology analyses that were conducted to support the regulatory decision on dosing in patients with renal impairment (RI)."( Canagliflozin use in patients with renal impairment-Utility of quantitative clinical pharmacology analyses in dose optimization.
Jain, L; Khurana, M; Marathe, A; Mehrotra, N; Sahajwalla, CG; Vaidyanathan, J; Zineh, I, 2015
)
1.86
" Compared with sitagliptin 100 mg, canagliflozin 300 mg demonstrated superior diabetes-related quality measure attainment, including glycemic, BP, and weight-related quality measures; there was no difference in LDL-C quality measure attainment between either dosage of canagliflozin and the 100-mg dosage of sitagliptin."( Diabetes-related quality measure attainment: canagliflozin versus sitagliptin based on a pooled analysis of 2 clinical trials.
Bailey, RA; Blonde, L; Meininger, GE; Rupnow, MF; Vijapurkar, U, 2014
)
0.94
" 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
") dosing with canagliflozin at the same total daily doses of 100 and 300 mg in healthy participants."( Pharmacokinetics and pharmacodynamics of once- and twice-daily multiple-doses of canagliflozin, a selective inhibitor of sodium glucose co-transporter 2, in healthy participants.
Curtin, CR; Devineni, D; Murphy, J; Polidori, D; Stieltjes, H; Wajs, E; Wang, SS, 2015
)
1
" dosing or vice versa."( Pharmacokinetics and pharmacodynamics of once- and twice-daily multiple-doses of canagliflozin, a selective inhibitor of sodium glucose co-transporter 2, in healthy participants.
Curtin, CR; Devineni, D; Murphy, J; Polidori, D; Stieltjes, H; Wajs, E; Wang, SS, 2015
)
0.64
" The 300-mg dose provides near-maximal effects on RTG throughout the full 24-h dosing interval, whereas the effect of the 100-mg dose on RTG is near-maximal for approximately 12 h and is modestly attenuated during the overnight period."( Clinical Pharmacokinetic, Pharmacodynamic, and Drug-Drug Interaction Profile of Canagliflozin, a Sodium-Glucose Co-transporter 2 Inhibitor.
Devineni, D; Polidori, D, 2015
)
0.64
" However, dosage adjustments are recommended for T2DM patients with renal impairment (eGFR ≥60 mL/min/1."( Population Pharmacokinetic Modeling of Canagliflozin in Healthy Volunteers and Patients with Type 2 Diabetes Mellitus.
De Winter, W; Devineni, D; Dunne, A; Hoeben, E; Neyens, M; Vermeulen, A, 2016
)
0.7
" 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
)
0.46
" 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
)
0.46
"Data from two clinical studies, one with once-daily, and the other with twice-daily dosing of canagliflozin as add-on to metformin were used (n = 1347)."( Dynamic population pharmacokinetic-pharmacodynamic modelling and simulation supports similar efficacy in glycosylated haemoglobin response with once or twice-daily dosing of canagliflozin.
de Trixhe, XW; de Winter, W; Devineni, D; Dunne, A; Hsu, CH; Pinheiro, J; Polidori, D, 2017
)
0.87
"Internal and external model validation demonstrated that the model adequately predicted HbA1c-lowering for canagliflozin once-daily and twice-daily dosing regimens."( Dynamic population pharmacokinetic-pharmacodynamic modelling and simulation supports similar efficacy in glycosylated haemoglobin response with once or twice-daily dosing of canagliflozin.
de Trixhe, XW; de Winter, W; Devineni, D; Dunne, A; Hsu, CH; Pinheiro, J; Polidori, D, 2017
)
0.86
" While the highest approved dosage of GLP-1RAs lowered HbA1c better than canagliflozin 300-mg, weight and SBP lowering could be non-inferior or slightly better with the latter drug."( Spotlight on Canagliflozin 300: review of its efficacy and an indirect comparison to other SGLT-2 inhibitors and long-acting GLP-1 receptor agonists.
Singh, AK; Singh, R, 2017
)
1.06
" Additionally, the linearity range, limit of detection and limit of quantification were determined and the selectivity was examined through the analysis of laboratory prepared mixtures and the combined dosage form of the drugs."( Different mathematical processing of absorption, ratio and derivative spectra for quantification of mixtures containing minor component: An application to the analysis of the recently co-formulated antidiabetic drugs; canagliflozin and metformin.
Elshahed, MS; Lotfy, HM; Mohamed, D, 2018
)
0.67
" In this chronic study male Sprague-Dawley rats were dosed orally with canagliflozin at high dose-levels (65 or 100 mg/kg/day) for 15 months and received either a standard diet or a glucose-free diet."( Renal tubular and adrenal medullary tumors in the 2-year rat study with canagliflozin confirmed to be secondary to carbohydrate (glucose) malabsorption in the 15-month mechanistic rat study.
De Jonghe, S; Feyen, B; Johnson, MD; Lammens, G; Mamidi, RNVS; Proctor, J; Vinken, P, 2017
)
0.92
" In this study, sensitive and precise spectrophotometric methods were developed for the determination of such hypoglycemic drug combinations in bulk powder and in pharmaceutical dosage form without prior separation."( Different resolution techniques for management of overlapped spectra: Application for the determination of novel co-formulated hypoglycemic drugs in their combined pharmaceutical dosage form.
Fawzy, MG; Mahrouse, MA; Moussa, BA, 2018
)
0.48
"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
)
0.82
" Continued research specific to canagliflozin is needed to clarify risks of adverse effects and determine optimal dosing requirements for canagliflozin in regard to cardiovascular risk reduction."( Clinical potential of canagliflozin in cardiovascular risk reduction in patients with type 2 diabetes.
Carter, BS; Roberts, MZ; Skelley, JW, 2018
)
1.08
"In this work, the transfer of oral solid dosage forms, currently manufactured via wet granulation, to a continuous direct compression process was considered."( Systematic development of a high dosage formulation to enable direct compression of a poorly flowing API: A case study.
Belen-Girona, J; Castro-Dominguez, B; Croker, DM; Cronin, P; Moroney, KM; Ruane, P; Schaller, BE; Walker, GM, 2019
)
0.51
" The PK and PD measurements obtained for rongliflozin demonstrate a dose-response relationship when the drug is administered at doses ranging from 10 to 50 mg in healthy people and in people with T2DM."( Pharmacokinetics and pharmacodynamics of rongliflozin, a novel selective inhibitor of sodium-glucose co-transporter-2, in people with type 2 diabetes mellitus.
Chen, H; Ding, Y; Li, C; Li, X; Liu, C; Liu, J; Wu, M; Zhang, H; Zhang, Y; Zhu, X, 2020
)
0.56
" 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
)
0.79
" Therefore, a meta-analysis was conducted to investigate the weight reduction effects and dose-response relationship of SGLT inhibitors and to assess the relative efficacy of SGLT1/SGLT2 inhibitors."( SGLT inhibitors on weight and body mass: A meta-analysis of 116 randomized-controlled trials.
Chai, P; Chan, MY; Cheong, AJY; Chia, AZQ; Chong, EY; Kong, WKF; Lee, CH; Lim, AYL; Ong, HT; Sia, CH; Syn, NL; Teo, YH; Teo, YN; Ting, AZH; Wong, RCC, 2022
)
0.72
"The lowest dosage of empagliflozin (10 mg) showed similar benefits on glycated hemoglobin (HbA1c) level, body weight, blood pressure, and total and cardiovascular mortality in comparison with the highest available dose (25 mg) in the EMPAREG trial."( Dose-ranging effects of SGLT2 inhibitors in patients with type 2 diabetes: a systematic review and meta-analysis.
Gross, JL; Leitão, CB; Pinto, LC; Rados, DV; Remonti, LR; Viana, MV, 2022
)
0.72
" Chronic adenine dosing resulted in severe CKD in vehicle-treated rats as indicated by a marked rise in serum creatinine levels, a marked decrease in creatinine clearance, and a disturbed mineral metabolism."( Progression of established non-diabetic chronic kidney disease is halted by metformin treatment in rats.
Corremans, R; D'Haese, PC; De Broe, ME; Leysen, H; Maudsley, S; Neven, E; Verhulst, A; Vervaet, BA, 2022
)
0.72
"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
"There is a pressing need for the development of greener liquid chromatographic bioanalytical methods for antidiabetic drugs for plasma monitoring and revisiting patients' dosage regimens."( Liquid chromatographic methods for the analysis of canagliflozin: concise overview and greener assessment.
Haneef, J; Khan, MD, 2023
)
1.16
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
hypoglycemic agentA drug which lowers the blood glucose level.
sodium-glucose transport protein subtype 2 inhibitorAny 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]

Drug Classes (3)

ClassDescription
C-glycosyl compoundA 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.
thiophenesCompounds containing at least one thiophene ring.
organofluorine compoundAn organofluorine compound is a compound containing at least one carbon-fluorine bond.
[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 Targets (3)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency39.81070.009610.525035.4813AID1479145
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Sodium/glucose cotransporter 1Homo sapiens (human)IC50 (µMol)0.94970.06071.61058.4440AID1447832; AID1546222; AID670284
Sodium/glucose cotransporter 2Homo sapiens (human)IC50 (µMol)0.00390.00050.16534.1000AID1396969; AID1447831; AID1546223; AID670283
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Sodium/glucose cotransporter 1Homo sapiens (human)EC50 (µMol)0.91000.00111.25448.3000AID1546902
Sodium/glucose cotransporter 2Homo sapiens (human)EC50 (µMol)0.00220.00110.11071.3900AID1546903
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (18)

Processvia Protein(s)Taxonomy
chloride transmembrane transportSodium/glucose cotransporter 1Homo sapiens (human)
glucose transmembrane transportSodium/glucose cotransporter 1Homo sapiens (human)
alpha-glucoside transportSodium/glucose cotransporter 1Homo sapiens (human)
intestinal D-glucose absorptionSodium/glucose cotransporter 1Homo sapiens (human)
response to inorganic substanceSodium/glucose cotransporter 1Homo sapiens (human)
pentose transmembrane transportSodium/glucose cotransporter 1Homo sapiens (human)
fucose transmembrane transportSodium/glucose cotransporter 1Homo sapiens (human)
galactose transmembrane transportSodium/glucose cotransporter 1Homo sapiens (human)
myo-inositol transportSodium/glucose cotransporter 1Homo sapiens (human)
transepithelial water transportSodium/glucose cotransporter 1Homo sapiens (human)
renal glucose absorptionSodium/glucose cotransporter 1Homo sapiens (human)
glucose import across plasma membraneSodium/glucose cotransporter 1Homo sapiens (human)
sodium ion import across plasma membraneSodium/glucose cotransporter 1Homo sapiens (human)
intestinal hexose absorptionSodium/glucose cotransporter 1Homo sapiens (human)
transport across blood-brain barrierSodium/glucose cotransporter 1Homo sapiens (human)
glucose transmembrane transportSodium/glucose cotransporter 1Homo sapiens (human)
sodium ion transportSodium/glucose cotransporter 1Homo sapiens (human)
alpha-glucoside transportSodium/glucose cotransporter 2Homo sapiens (human)
carbohydrate metabolic processSodium/glucose cotransporter 2Homo sapiens (human)
hexose transmembrane transportSodium/glucose cotransporter 2Homo sapiens (human)
renal glucose absorptionSodium/glucose cotransporter 2Homo sapiens (human)
glucose import across plasma membraneSodium/glucose cotransporter 2Homo sapiens (human)
sodium ion import across plasma membraneSodium/glucose cotransporter 2Homo sapiens (human)
sodium ion transportSodium/glucose cotransporter 2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (12)

Processvia Protein(s)Taxonomy
galactose transmembrane transporter activitySodium/glucose cotransporter 1Homo sapiens (human)
glucose transmembrane transporter activitySodium/glucose cotransporter 1Homo sapiens (human)
myo-inositol:sodium symporter activitySodium/glucose cotransporter 1Homo sapiens (human)
water transmembrane transporter activitySodium/glucose cotransporter 1Homo sapiens (human)
glucose:sodium symporter activitySodium/glucose cotransporter 1Homo sapiens (human)
protein bindingSodium/glucose cotransporter 1Homo sapiens (human)
pentose transmembrane transporter activitySodium/glucose cotransporter 1Homo sapiens (human)
fucose transmembrane transporter activitySodium/glucose cotransporter 1Homo sapiens (human)
alpha-glucoside transmembrane transporter activitySodium/glucose cotransporter 1Homo sapiens (human)
galactose:sodium symporter activitySodium/glucose cotransporter 1Homo sapiens (human)
D-glucose transmembrane transporter activitySodium/glucose cotransporter 1Homo sapiens (human)
low-affinity glucose:sodium symporter activitySodium/glucose cotransporter 2Homo sapiens (human)
glucose:sodium symporter activitySodium/glucose cotransporter 2Homo sapiens (human)
protein bindingSodium/glucose cotransporter 2Homo sapiens (human)
alpha-glucoside transmembrane transporter activitySodium/glucose cotransporter 2Homo sapiens (human)
D-glucose transmembrane transporter activitySodium/glucose cotransporter 2Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (10)

Processvia Protein(s)Taxonomy
early endosomeSodium/glucose cotransporter 1Homo sapiens (human)
plasma membraneSodium/glucose cotransporter 1Homo sapiens (human)
apical plasma membraneSodium/glucose cotransporter 1Homo sapiens (human)
brush border membraneSodium/glucose cotransporter 1Homo sapiens (human)
intracellular organelleSodium/glucose cotransporter 1Homo sapiens (human)
perinuclear region of cytoplasmSodium/glucose cotransporter 1Homo sapiens (human)
extracellular exosomeSodium/glucose cotransporter 1Homo sapiens (human)
intracellular vesicleSodium/glucose cotransporter 1Homo sapiens (human)
plasma membraneSodium/glucose cotransporter 1Homo sapiens (human)
plasma membraneSodium/glucose cotransporter 2Homo sapiens (human)
membraneSodium/glucose cotransporter 2Homo sapiens (human)
apical plasma membraneSodium/glucose cotransporter 2Homo sapiens (human)
extracellular exosomeSodium/glucose cotransporter 2Homo sapiens (human)
plasma membraneSodium/glucose cotransporter 2Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (20)

Assay IDTitleYearJournalArticle
AID1447833Selectivity ratio of IC50 for human SGLT1 expressed in CHO cells to IC50 for human SGLT2 expressed in CHO cells2017Journal 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.
AID670287Inhibition of CYP3A4 using BFC substrate in which compound added to reaction mixture before addition of BFC substrate by fluorometric assay2012Bioorganic & 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.
AID670288Potency 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 o2012Bioorganic & 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.
AID1546903Inhibition of SGLT2 (unknown origin)2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
The Race to Bash NASH: Emerging Targets and Drug Development in a Complex Liver Disease.
AID1447847Antidiabetic 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 less than 3 days2017Journal 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.
AID670285Selectivity index, ratio of IC50 for human SGLT1 to IC50 for human SGLT22012Bioorganic & 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.
AID1447841Antidiabetic activity in Sprague-Dawley rat assessed as increase in urinary glucose excrection at 1 to 10 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 24 2017Journal 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.
AID1546902Inhibition of SGLT1 (unknown origin)2020Journal of medicinal chemistry, 05-28, Volume: 63, Issue:10
The Race to Bash NASH: Emerging Targets and Drug Development in a Complex Liver Disease.
AID670283Inhibition of human SGLT2 expressed in CHO-K1 cells by [14C]AMG uptake assay2012Bioorganic & 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.
AID1546222Inhibition of human SGLT12019European journal of medicinal chemistry, Dec-15, Volume: 184Synthetic strategy and SAR studies of C-glucoside heteroaryls as SGLT2 inhibitor: A review.
AID1546223Inhibition of human SGLT22019European journal of medicinal chemistry, Dec-15, Volume: 184Synthetic strategy and SAR studies of C-glucoside heteroaryls as SGLT2 inhibitor: A review.
AID1447831Inhibition of human SGLT2 expressed in CHO cells assessed as decrease in uptake of [14C]AMG after 120 mins by TopCount method2017Journal 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.
AID1396969Inhibition of SGLT2 (unknown origin)2018Bioorganic & 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.
AID670286Inhibition of CYP3A4 using BFC substrate in which compound added to reaction mixture simultaneously with BFC substrate by fluorometric assay2012Bioorganic & 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.
AID1447832Inhibition of human SGLT1 expressed in CHO cells assessed as decrease in uptake of [14C]AMG after 120 mins by TopCount method2017Journal 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.
AID670284Inhibition of human SGLT1 expressed in CHO-K1 cells by [14C]AMG uptake assay2012Bioorganic & 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.
AID1546232Selectivity ratio of IC50 for inhibition of human SGLT1 to IC50 for inhibition of human SGLT22019European journal of medicinal chemistry, Dec-15, Volume: 184Synthetic strategy and SAR studies of C-glucoside heteroaryls as SGLT2 inhibitor: A review.
AID1347411qHTS 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) Libary2020ACS 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.
AID1346965Human Sodium/glucose cotransporter 2 (Hexose transporter family)2012PloS one, , Volume: 7, Issue:2
Effect of canagliflozin on renal threshold for glucose, glycemia, and body weight in normal and diabetic animal models.
AID1346950Human Sodium/glucose cotransporter 1 (Hexose transporter family)2012PloS one, , Volume: 7, Issue:2
Effect of canagliflozin on renal threshold for glucose, glycemia, and body weight in normal and diabetic animal models.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (976)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's588 (60.25)24.3611
2020's388 (39.75)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 84.39

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index84.39 (24.57)
Research Supply Index7.08 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index147.71 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (84.39)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials194 (19.44%)5.53%
Reviews220 (22.04%)6.00%
Case Studies45 (4.51%)4.05%
Observational30 (3.01%)0.25%
Other509 (51.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (133)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
An Open-Label, Single-Dose Study to Assess the Absolute Oral Bioavailability and Pharmacokinetics of JNJ-28431754 (Canagliflozin) Administered as a 300-mg Oral Tablet and an Intravenous Microdose of 10 mcg 14C-canagliflozin in Healthy Male Subjects [NCT01157000]Phase 19 participants (Actual)Interventional2010-05-31Completed
An Open-Label, Randomized, Parallel-Group, Single-Center Study to Evaluate the Single and Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Healthy Subjects [NCT01281579]Phase 127 participants (Actual)Interventional2011-01-31Completed
A Double-Blind, Randomized, Placebo Controlled, 2-Period Crossover Study to Evaluate the Effect of a Single Dose of JNJ-28431754 (Canagliflozin) on Gastrointestinal Glucose Absorption and Metabolism in Healthy Subjects [NCT01173549]Phase 126 participants (Actual)Interventional2010-11-30Completed
An Open-Label, Multiple-Dose Study to Assess the Steady-State Pharmacokinetics, Pharmacodynamics and Safety of Once-Daily Versus Twice-Daily Dosing With Canagliflozin in Healthy Subjects [NCT01286103]Phase 134 participants (Actual)Interventional2011-01-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Mechanistic Study to Evaluate the Effects of Canagliflozin on Intravascular Volume and Hemodynamics in Subjects With Type 2 Diabetes Mellitus and Heart Failure [NCT03190798]Phase 40 participants (Actual)Interventional2017-09-01Withdrawn(stopped due to Study has been withdrawn from IRB review pending IND revision)
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who H [NCT01064414]Phase 3272 participants (Actual)Interventional2010-06-30Completed
A Double-Blind, Placebo-Controlled, Randomized, Crossover, Multicenter Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Subjects With Type 2 Diabetes Mellitus [NCT01381887]Phase 137 participants (Actual)Interventional2011-06-30Completed
An Open-Label, Single-Dose, Randomized, 3-Period, Crossover Study to Evaluate the Pharmacokinetic Dose Proportionality of Canagliflozin of 50, 100, and 300 mg Under Fasted Conditions in Healthy Subjects [NCT01340677]Phase 124 participants (Actual)Interventional2011-05-31Completed
Metformin And Cardiovascular Effectiveness vs SGLT2 (MACES) [NCT03627039]20,000 participants (Anticipated)Observational2018-09-01Active, not recruiting
Retrospective Observational Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Patients With BMI>25 kg/m^2, in Real World Clinical Setting [NCT03604224]178 participants (Actual)Observational2018-09-05Completed
An Open-Label Study to Evaluate the Pharmacokinetics of a Single Oral Dose of 300 mg JNJ-28431754 (Canagliflozin) in Subjects With Various Degrees of Impaired Hepatic Function Compared With Subjects With Normal Hepatic Function [NCT01186588]Phase 124 participants (Actual)Interventional2010-08-31Completed
An Open-Label Drug Interaction Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Administered Alone and in Combination With Multiple-Dose JNJ-28431754 (Canagliflozin) in Healthy Male and Female Subjects [NCT01195324]Phase 114 participants (Actual)Interventional2010-09-30Completed
Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus [NCT03249506]25,358 participants (Actual)Observational2016-05-12Completed
Canagliflozin vs. Placebo for Post Bariatric Patients With Persistent Type 2 Diabetes [NCT02912455]Phase 416 participants (Actual)Interventional2017-01-05Terminated(stopped due to Study was terminated due to difficulty with reaching enrollment goals)
A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 50 mg/500 mg) With Respect to the Individual Components of Ca [NCT02065752]Phase 12 participants (Actual)Interventional2014-02-28Completed
A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 150 mg/500 mg) With Respect to the Individual Components of C [NCT02071368]Phase 13 participants (Actual)Interventional2014-02-28Completed
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release (IR) 1 x (50 mg/500 mg) With Respect to the [NCT02220218]Phase 12 participants (Actual)Interventional2014-08-31Completed
A Single-Dose, Open-Label, Randomized, 2-Period, 2-Sequence, Crossover Study to Determine the Effect of Food Coadministration on the Pharmacokinetics of 300 mg Canagliflozin in Healthy Subjects [NCT01343290]Phase 124 participants (Actual)Interventional2011-04-30Completed
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 41,167 participants (Anticipated)Interventional2021-06-30Not yet recruiting
A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 50 mg/1,000 mg) With Respect to the Individual Components of [NCT02077803]Phase 147 participants (Actual)Interventional2014-03-31Completed
Impact of Canaglifloxin on Gut Hormone Secretion After Gastric Bypass [NCT03426956]10 participants (Anticipated)Interventional2018-02-08Recruiting
Effect of Glimepiride, Vildagliptin, Pioglitazone and Canagliflozin on Durability of Glycemic Control After Metformin Failure in Type 2 Diabetes [NCT02142309]Phase 4450 participants (Anticipated)Interventional2005-10-31Recruiting
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)Interventional2018-10-10Recruiting
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release (IR) 1 x (150 mg/500 mg) With Respect to the [NCT02221180]Phase 12 participants (Actual)Interventional2014-08-31Completed
Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes [NCT03136484]Phase 3788 participants (Actual)Interventional2017-03-15Completed
A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Subjects With Type 2 Diabetes Mellitus [NCT01128985]Phase 139 participants (Actual)Interventional2010-03-31Completed
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)Observational2018-02-22Completed
Canagliflozin: Impact on Health Status, Quality of Life, and Functional Status in Heart Failure [NCT04252287]Phase 3476 participants (Actual)Interventional2020-03-10Completed
Canagliflozin Continuous Glucose Monitoring (CANA CGM) Trial: A Pilot Randomized, Double-Blind, Controlled, Crossover Study on the Effects of the SGLT-2 Inhibitor Canagliflozin (vs. the DPP-4 Inhibitor Sitagliptin) on Glucose Variability in Mexican Patien [NCT03267576]Phase 464 participants (Actual)Interventional2017-10-27Completed
An Open-Label, Two-Period, Fixed-Sequence Study to Explore the Effects of Multiple Doses of Hydrochlorothiazide on the Pharmacodynamics, Pharmacokinetics, and Safety of Multiple Doses of Canagliflozin in Healthy Subjects [NCT01294631]Phase 130 participants (Actual)Interventional2011-03-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Di [NCT01081834]Phase 3678 participants (Actual)Interventional2010-03-31Completed
Pharmacogenomics to Predict Responses to SGLT2 Inhibitors [NCT02891954]Phase 1700 participants (Anticipated)Interventional2016-09-30Enrolling by invitation
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) 1 x (50 mg/500 mg) With Respect to the M [NCT02865668]Phase 144 participants (Actual)Interventional2016-08-31Completed
TriMaster: Randomised Double-Blind Crossover Study of a DPP4 Inhibitor, SGLT2 Inhibitor and Thiazolidinedione as Third Line Therapy in Patients With Type 2 Diabetes Who Have Suboptimal Glycaemic Control on Dual Therapy With Metformin and a Sulphonylurea [NCT02653209]Phase 4525 participants (Actual)Interventional2016-11-01Completed
A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ-28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus [NCT01032629]Phase 34,330 participants (Actual)Interventional2009-12-09Completed
Nanjing Medical University, Nanjing First Hospital [NCT05856578]Phase 460 participants (Actual)Interventional2022-03-15Active, not recruiting
A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 150 mg/1,000 mg) With Respect to the Individual Components of [NCT02073227]Phase 152 participants (Actual)Interventional2014-02-28Completed
Harmonizing RCT-Duplicate Emulations: A Real World Replication Program Analyzing Three Clinical Trials, CANVAS, LEADER, and SAVOR TIMI in Type 2 Diabetes Mellitus [NCT06099067]239,990 participants (Actual)Observational2020-05-15Completed
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of JNJ-28431754 in Type 2 Diabetes Mellitus Patients [NCT00963768]Phase 1116 participants (Actual)Interventional2007-06-30Completed
Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients [NCT02324842]45 participants (Actual)Interventional2014-11-30Completed
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)Observational2021-09-01Recruiting
Canagliflozin Administration in Non-diabetic Women With Polycystic Ovarian Syndrome [NCT04973891]Phase 1/Phase 252 participants (Actual)Interventional2021-04-07Completed
A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors With PIK3CA or KRAS Mutations [NCT04073680]Phase 1/Phase 260 participants (Anticipated)Interventional2020-09-01Not yet recruiting
Effects of SGLT2 Inhibition Treatment on Different Levels of Albuminuria in Patients With Type 2 Diabetes: a Prospective Interventional Study [NCT04127084]Phase 470 participants (Anticipated)Interventional2019-10-15Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Investigate the Safety and Efficacy of JNJ-28431754 in Nondiabetic Overweight and Obese Subjects [NCT00650806]Phase 2376 participants (Actual)Interventional2008-05-31Completed
Role of Canagliflozin on Gene Expression and Function of CD34+ Endothelial Progenitor Cells and Renal Function in Patients With Type 2 Diabetes [NCT02964585]Phase 434 participants (Actual)Interventional2016-11-30Completed
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) 1 x (50 mg/1000 mg) With Respect to the [NCT02851095]Phase 144 participants (Actual)Interventional2016-08-31Completed
Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes vs Best Medical Treatment [NCT02041234]Phase 440 participants (Anticipated)Interventional2014-02-28Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Contr [NCT01106651]Phase 3716 participants (Actual)Interventional2010-06-30Completed
Safety and Efficacy of Canagliflozin in Advanced CKD [NCT05309785]Phase 444 participants (Anticipated)Interventional2022-11-24Recruiting
An Open-Label, Fixed-Sequence Study to Assess Effects of Steady-State Rifampin on the Single-Dose Pharmacokinetics of Canagliflozin in Healthy Subjects [NCT01395927]Phase 114 participants (Actual)Interventional2011-07-31Completed
Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV: A Randomized Controlled Trial. [NCT05135039]218 participants (Anticipated)Interventional2022-01-01Recruiting
Molecular Mechanisms of SGLT2 Inhibition in Diabetic Kidney Disease [NCT05507892]Phase 240 participants (Anticipated)Interventional2022-10-10Recruiting
Effects of SGLT2 Inhibitors on Islet Cell Function and Insulin Sensitivity in Patients of Type 2 Diabetes Mellitus [NCT04014192]Phase 440 participants (Anticipated)Interventional2019-09-01Recruiting
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Met [NCT01106690]Phase 3344 participants (Actual)Interventional2010-06-30Completed
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) 1 x (150 mg/1000 mg) With Respect to the [NCT02851212]Phase 144 participants (Actual)Interventional2016-08-31Completed
The Effect of add-on Canagliflozin in Patients With Type 2 Diabetes Treated With ≥200 Units Per Day of U-500 Insulin [NCT02597309]Phase 40 participants (Actual)Interventional2015-11-30Withdrawn
A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Parallel Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered SGLT2 Inhibitor JNJ-28431754 [NCT00642278]Phase 2451 participants (Actual)Interventional2008-04-30Completed
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 160 participants (Actual)Interventional2013-07-31Completed
A Phase 1, Single-center, Partially Double-blind, Randomized, Single-dose, 3-Period Crossover Study to Assess the Pharmacodynamic Effects of LX4211 and INVOKANA™ (Canagliflozin) in Healthy Subjects Using Stable Isotope Tracer Methods [NCT01916863]Phase 125 participants (Actual)Interventional2013-08-31Completed
Open-Label, Multicenter, Multiple Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents ≥10 to <18 Years of Age With Type 2 Diabetes Mellitus and Currently on a Stable Dose of Metf [NCT02000700]Phase 117 participants (Actual)Interventional2014-03-31Completed
A Double-Blind, Placebo-Controlled, Randomized, Parallel Groups, Multicenter Study to Investigate the Effects of Canagliflozin on Insulin Sensitivity, Hepatic Fat Content and Beta Cell Function in Subjects With Type 2 Diabetes Mellitus [NCT02009488]Phase 159 participants (Actual)Interventional2014-09-08Completed
Targeting Insulin Feedback to Enhance Alpelisib (TIFA): A Phase 2 Randomized Control Trial in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer [NCT05090358]Phase 2106 participants (Anticipated)Interventional2021-10-08Recruiting
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Met [NCT01340664]Phase 2279 participants (Actual)Interventional2011-07-31Completed
A Randomized, Double-Blind, Placebo and Active-Controlled, 4-Arm, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Con [NCT01106677]Phase 31,284 participants (Actual)Interventional2010-05-31Completed
A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen: The 'Can Do Ramadan' Study [NCT02694263]Phase 425 participants (Actual)Interventional2016-07-31Completed
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) 1 x (150 mg/500 mg) With Respect to the [NCT02846506]Phase 144 participants (Actual)Interventional2016-08-31Completed
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Met [NCT01106625]Phase 3469 participants (Actual)Interventional2010-05-31Completed
A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Co [NCT00968812]Phase 31,452 participants (Actual)Interventional2009-09-30Completed
A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Versus Sitagliptin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformi [NCT01137812]Phase 3756 participants (Actual)Interventional2010-07-31Completed
An Open-Label, Fixed-Sequence Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Subjects [NCT01428284]Phase 114 participants (Actual)Interventional2011-08-31Completed
A Double-Blind, Placebo-Controlled, Randomized, Parallel-Groups Study to Investigate the Effects of JNJ-28431754 (Canagliflozin) on Plasma Volume and Renal Function in Subjects With Type 2 Diabetes Mellitus [NCT01483781]Phase 136 participants (Actual)Interventional2011-12-31Completed
A Prospective, Multi-centric, Open-label, Single-arm, Phase 4 Study to Evaluate the Safety and Efficacy of Canagliflozin + Metformin Hydrochloride IR Fixed-dose Combination as an Adjunct to Diet and Exercise to Improve Glycemic Control in Indian Adult Pat [NCT04288778]Phase 4276 participants (Actual)Interventional2020-11-25Completed
An Open-label Drug-Drug Interaction Study in Healthy Female Subjects to Explore the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics and Safety of Single Doses of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel [NCT01714193]Phase 130 participants (Actual)Interventional2008-02-29Completed
Canagliflozin in Advanced Renal Disease With MRI Endpoints [NCT06182839]Phase 292 participants (Anticipated)Interventional2024-03-30Not yet recruiting
Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers [NCT02404870]Phase 167 participants (Actual)Interventional2014-09-16Completed
Mechanism of the Effect by Sodium-glucose Cotransporter-2 Inhibitor on Obesity Associated Cardiomyopathy [NCT05764811]40 participants (Actual)Interventional2020-03-06Completed
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagl [NCT01518712]Phase 164 participants (Actual)Interventional2011-09-30Completed
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study [NCT05220917]781,430 participants (Anticipated)Observational2021-08-01Active, not recruiting
An Open-Label, Fixed Sequence Study to Investigate the Potential for Pharmacokinetic and Pharmacodynamic Interaction Between Single-Dose Metformin and Multiple-Dose Canagliflozin in Healthy Subjects [NCT01273571]Phase 118 participants (Actual)Interventional2010-12-31Completed
Effect of Canagliflozin in T1DM After Interruption of Continuous Subcutaneous Insulin Infusion [NCT02673138]10 participants (Actual)Interventional2016-01-31Completed
Canagliflozin Targeting Vascular Inflammation: An Ottawa Imaging Study - A Pilot Study [NCT05427084]Phase 2/Phase 324 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Canagliflozin: a New Therapeutic Option in Patients That Present Postprandial Hyperinsulinemic Hypoglycemia After Roux-en-Y-gastric By-pass [NCT04720859]40 participants (Anticipated)Interventional2018-01-05Recruiting
Therapeutic Effects of Canagliflozin on the Liver Inflammation Damage and Lipoprotein Metabolism in Patients With Type 2 Diabetes Mellitus Combined With Nonalcoholic Fatty Liver Disease [NCT05422092]80 participants (Anticipated)Interventional2022-09-20Not yet recruiting
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (150 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1x300 mg) and Metformin IR Tab [NCT01508182]Phase 164 participants (Actual)Interventional2012-01-31Completed
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/500 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Ta [NCT01508195]Phase 164 participants (Actual)Interventional2012-01-31Completed
A Double-Blind, Randomized, Placebo-Controlled, 2-Way Cross-Over Study to Evaluate the Effect of Single Dose Canagliflozin on Kinetics of C-Peptide in Healthy Subjects [NCT01665638]Phase 110 participants (Actual)Interventional2012-09-30Completed
A Double-Blind, Randomized, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of JNJ-28431754 (Canagliflozin) in Healthy Chinese Subjects [NCT01707316]Phase 115 participants (Actual)Interventional2012-06-30Completed
An Open-Label, 2-Period, Crossover Study to Evaluate the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics of Multiple Doses of Digoxin in Healthy Subjects. [NCT01714206]Phase 118 participants (Actual)Interventional2009-06-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Blood Pressure Reduction With Ambulatory Blood Pressure Monitoring (ABPM), Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Hypert [NCT01939496]Phase 4171 participants (Actual)Interventional2013-10-31Completed
An Open-Label, Single Sequence Study to Assess the Effect of a Single Dose of Cyclosporine on the Steady-State Pharmacokinetics of JNJ-28431754 (Canagliflozin) in Healthy Adult Subjects [NCT01718652]Phase 118 participants (Actual)Interventional2011-02-28Completed
An Open-Label Drug-Drug Interaction Study in Healthy Subjects to Explore the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics and Safety of Single Doses of Glyburide [NCT01733108]Phase 129 participants (Actual)Interventional2008-07-31Completed
A Single-Dose, Open-Label, Randomized, Two-Way, Cross-Over Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-28431754 in Healthy Indian Subjects [NCT01748526]Phase 116 participants (Actual)Interventional2008-08-31Completed
A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of JNJ-28431754 in Otherwise Healthy Obese Male and Female Subjects [NCT01756404]Phase 180 participants (Actual)Interventional2007-06-14Completed
An Open-Label, Fixed Sequence, Single and Multiple Dose Study in Male and Female Subjects to Investigate the Potential for Pharmacokinetic and Pharmacodynamic Interaction Between Metformin and JNJ-28431754 [NCT01756417]Phase 118 participants (Actual)Interventional2007-10-31Completed
An Open-Label, Single-Dose Study to Evaluate JNJ-28431754 Pharmacokinetics, Pharmacodynamics and Safety in Non-Diabetic Subjects With Varying Degrees of Renal Function [NCT01759576]Phase 140 participants (Actual)Interventional2008-03-31Completed
A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Four-Way Crossover Study Evaluating ECG Intervals in Healthy Adults Receiving a Single, Oral Dose of JNJ-28431754 at Therapeutic and Supra-Therapeutic Doses [NCT01787357]Phase 160 participants (Actual)Interventional2008-06-30Completed
A Open-Label, Single Sequence Study to Assess the Pharmacokinetics and Pharmacodynamics of Simvastatin Alone and of Simvastatin in Combination With JNJ-28431754 in Healthy Adult Subjects [NCT01821027]Phase 122 participants (Actual)Interventional2008-08-31Completed
Pharmacogenetics of Sodium-dependent Glucose Transporter-2 (SGLT2) Inhibitors [NCT02462421]Phase 430 participants (Actual)Interventional2015-06-01Terminated(stopped due to Did not meet recruitment targets.)
Replication of Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes (CANVAS Trial) [NCT03936010]152,202 participants (Actual)Observational2017-09-22Completed
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of FDC Tablets of Canagliflozin and Metformin IR (2x150 mg/1000 mg) With Respect to the Individual Components of Canagliflozin (1x300 mg) and Metformin IR (2 [NCT01463228]Phase 183 participants (Actual)Interventional2011-09-30Completed
Pivotal BE CANA/MET IR FDC - Low Strength [NCT01463774]Phase 174 participants (Actual)Interventional2011-09-30Completed
Canagliflozin-Mealtime Insulin Rescue [NCT02624908]Phase 440 participants (Anticipated)Interventional2016-01-31Active, not recruiting
Clinical Study of Capeline Combined With Gemcitabine in the Treatment of Pancreatic Cancer [NCT05903703]20 participants (Anticipated)Interventional2023-10-01Not yet recruiting
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy [NCT03436693]Phase 3308 participants (Actual)Interventional2018-02-15Completed
Therapeutic Effects of Canagliflozin on the Liver Inflammation Damage and Lipoprotein Metabolism in Patients With Type 2 Diabetes Mellitus Combined With Nonalcoholic Fatty Liver Disease [NCT05513729]80 participants (Anticipated)Observational [Patient Registry]2022-08-18Recruiting
Investigating the Protective Effect of Newer Antidiabetic Drugs on Cognitive Decline in Diabetic Patients [NCT05347459]100 participants (Anticipated)Observational2022-03-02Recruiting
A Randomized Active-Control Double-Blinded Study to Evaluate the Treatment of Diabetes in Patients With Systolic Heart Failure [NCT02920918]Phase 436 participants (Actual)Interventional2016-10-31Completed
Mechanisms of Weight Loss With SGLT2 Inhibition [NCT02360774]Phase 430 participants (Actual)Interventional2015-02-28Completed
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR [NCT01454622]Phase 164 participants (Actual)Interventional2011-09-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese [NCT02243202]Phase 2335 participants (Actual)Interventional2014-09-30Completed
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin in Patients With Inadequate Glycemic Control on Teneligliptin) [NCT02354235]Phase 3138 participants (Actual)Interventional2015-01-31Completed
A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy [NCT02065791]Phase 34,401 participants (Actual)Interventional2014-02-17Completed
An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-28431754 in Healthy Male Subjects Following a Single Oral Dose Administration of 14C-JNJ-28431754 [NCT01791231]Phase 16 participants (Actual)Interventional2007-08-31Completed
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 3424 participants (Actual)Interventional2015-11-30Completed
A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus [NCT01989754]Phase 45,813 participants (Actual)Interventional2014-01-16Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 18-Week Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alon [NCT01381900]Phase 3678 participants (Actual)Interventional2011-08-31Completed
An Open-Label Study to Compare Two Methods for Determining the Renal Threshold for Glucose in Subjects With Type 2 Diabetes Mellitus [NCT01273558]Phase 128 participants (Actual)Interventional2011-01-31Completed
A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Contr [NCT02025907]Phase 4218 participants (Actual)Interventional2014-02-28Completed
An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus [NCT02622113]Phase 4139 participants (Actual)Interventional2014-12-31Completed
Effect of Canagliflozin on Cardiac Microcirculation Function in Patients With Type 2 Diabetes Mellitus Complicated With Cardiovascular Risk Factors [NCT05367063]Phase 470 participants (Anticipated)Interventional2022-01-05Recruiting
Efficacy and Safety of Early Initiation of Canagliflozin in Patients With Acute Decompansted Heart Failure [NCT05364190]Phase 3144 participants (Anticipated)Interventional2022-06-04Recruiting
Multicentre Prospective Open Label Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy. [NCT04662723]Phase 4878 participants (Anticipated)Interventional2023-05-01Recruiting
A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (≥10 to <18 Years) With Type 2 Diabetes Mellitus [NCT03170518]Phase 3171 participants (Actual)Interventional2017-07-21Completed
A Randomized Phase 2, Double-blind, Placebo-controlled, Treat-to-Target, Parallel-group, 3-arm, Multicenter Study to Assess the Efficacy and Safety of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Subjects With Type 1 Diabetes Mellitus [NCT02139943]Phase 2352 participants (Actual)Interventional2014-05-31Completed
The Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome: A Randomized, Open Label Trial [NCT04700839]Phase 468 participants (Actual)Interventional2020-05-01Completed
A Randomized, Double-Blind, 5-Arm, Parallel-Group, 26-Week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in Combination With Metformin as Initial Combination Therapy in the Treatment of Subjects With Type 2 Diabete [NCT01809327]Phase 31,186 participants (Actual)Interventional2013-06-04Completed
Subclinical Inflammation, Myocardial Function and Fatty Acid Metabolism in Patients With Type 2 Diabetes and Heart Failure: Impact of a Short-term Treatment With Canagliflozin - a Pilot Study [NCT03298009]0 participants (Actual)Interventional2017-11-01Withdrawn(stopped due to end of contract negociations)
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 4880 participants (Actual)Interventional2020-09-04Active, not recruiting
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin in Patients With Inadequate Glycemic Control on Canagliflozin) [NCT02354222]Phase 3154 participants (Actual)Interventional2015-01-31Completed
An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to GLP-1 Analogue in Subjects With Type 2 Diabetes Mellitus [NCT02227849]Phase 471 participants (Actual)Interventional2014-08-31Completed
Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus [NCT02220907]Phase 3153 participants (Actual)Interventional2014-08-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus [NCT02220920]Phase 4146 participants (Actual)Interventional2014-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00642278 (6) [back to overview]Percent Change in Body Weight From Baseline to Week 12
NCT00642278 (6) [back to overview]Absolute Change in Body Weight From Baseline to Week 12
NCT00642278 (6) [back to overview]Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12
NCT00642278 (6) [back to overview]Change in HbA1c From Baseline to Week 12
NCT00642278 (6) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12
NCT00642278 (6) [back to overview]Percentage of Patients With Symptoms of Hypoglycemia
NCT00650806 (8) [back to overview]Change in Waist Circumference From Baseline to Week 12
NCT00650806 (8) [back to overview]Change in Hip Circumference From Baseline to Week 12
NCT00650806 (8) [back to overview]Change in Body Mass Index (BMI) From Baseline to Week 12
NCT00650806 (8) [back to overview]Absolute Change in Body Weight From Baseline to Week 12
NCT00650806 (8) [back to overview]Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12
NCT00650806 (8) [back to overview]Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12
NCT00650806 (8) [back to overview]Percent Change in Body Weight From Baseline to Week 12
NCT00650806 (8) [back to overview]Change in Waist/Hip Ratio From Baseline to Week 12
NCT00968812 (4) [back to overview]Change in HbA1c From Baseline to Week 104
NCT00968812 (4) [back to overview]Change in HbA1c From Baseline to Week 52
NCT00968812 (4) [back to overview]Percent Change in Body Weight From Baseline to Week 52
NCT00968812 (4) [back to overview]Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52
NCT01032629 (13) [back to overview]Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT)
NCT01032629 (13) [back to overview]Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment
NCT01032629 (13) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment
NCT01032629 (13) [back to overview]Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment
NCT01032629 (13) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment
NCT01032629 (13) [back to overview]Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment
NCT01032629 (13) [back to overview]Percentage of Participants With Progression of Albuminuria at the End-of-Treatment
NCT01032629 (13) [back to overview]Percent Change From Baseline in Body Weight at End-of-Treatment
NCT01032629 (13) [back to overview]Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke
NCT01032629 (13) [back to overview]Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment
NCT01032629 (13) [back to overview]Change From Baseline in Triglycerides Levels at End-of-Treatment
NCT01032629 (13) [back to overview]Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment
NCT01032629 (13) [back to overview]Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment
NCT01064414 (3) [back to overview]Change in HbA1c From Baseline to Week 26
NCT01064414 (3) [back to overview]Percentage of Patients With HbA1c <7% at Week 26
NCT01064414 (3) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
NCT01081834 (16) [back to overview]Change in HbA1c From Baseline to Week 26 (Main Study)
NCT01081834 (16) [back to overview]Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)
NCT01081834 (16) [back to overview]Percent Change in Body Weight From Baseline to Week 26 (Main Study)
NCT01081834 (16) [back to overview]Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)
NCT01081834 (16) [back to overview]Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)
NCT01081834 (16) [back to overview]Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)
NCT01081834 (16) [back to overview]Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)
NCT01081834 (16) [back to overview]Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)
NCT01081834 (16) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)
NCT01081834 (16) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)
NCT01081834 (16) [back to overview]Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)
NCT01081834 (16) [back to overview]Percentage of Patients With HbA1c <7% at Week 26 (Main Study)
NCT01081834 (16) [back to overview]Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)
NCT01081834 (16) [back to overview]Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)
NCT01081834 (16) [back to overview]Percent Change in Triglycerides From Baseline to Week 26 (Main Study)
NCT01081834 (16) [back to overview]Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)
NCT01106625 (7) [back to overview]Percent Change in Triglycerides From Baseline to Week 26
NCT01106625 (7) [back to overview]Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
NCT01106625 (7) [back to overview]Percent Change in Body Weight From Baseline to Week 26
NCT01106625 (7) [back to overview]Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
NCT01106625 (7) [back to overview]Percentage of Patients With HbA1c <7% at Week 26
NCT01106625 (7) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
NCT01106625 (7) [back to overview]Change in HbA1c From Baseline to Week 26
NCT01106651 (14) [back to overview]Change in HbA1c From Baseline to Week 26
NCT01106651 (14) [back to overview]Percent Change in Body Weight From Baseline to Week 26
NCT01106651 (14) [back to overview]Percentage of Patients With HbA1c <7% at Week 26
NCT01106651 (14) [back to overview]Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
NCT01106651 (14) [back to overview]Percent Change in Triglycerides From Baseline to Week 26
NCT01106651 (14) [back to overview]Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26
NCT01106651 (14) [back to overview]Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26
NCT01106651 (14) [back to overview]Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26
NCT01106651 (14) [back to overview]Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26
NCT01106651 (14) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
NCT01106651 (14) [back to overview]Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
NCT01106651 (14) [back to overview]Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
NCT01106651 (14) [back to overview]Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
NCT01106651 (14) [back to overview]Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition
NCT01106677 (14) [back to overview]Change in 2-hour Post-prandial Glucose From Baseline to Week 26
NCT01106677 (14) [back to overview]Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
NCT01106677 (14) [back to overview]Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52
NCT01106677 (14) [back to overview]Percent Change in Triglycerides From Baseline to Week 26
NCT01106677 (14) [back to overview]Change in Systolic Blood Pressure (SBP) From Baseline to Week 52
NCT01106677 (14) [back to overview]Percentage of Patients With HbA1c <7% at Week 26
NCT01106677 (14) [back to overview]Change in HbA1c From Baseline to Week 52
NCT01106677 (14) [back to overview]Percent Change in Body Weight From Baseline to Week 26
NCT01106677 (14) [back to overview]Percent Change in Body Weight From Baseline to Week 52
NCT01106677 (14) [back to overview]Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
NCT01106677 (14) [back to overview]Change in HbA1c From Baseline to Week 26
NCT01106677 (14) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
NCT01106677 (14) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
NCT01106677 (14) [back to overview]Percent Change in Triglycerides From Baseline to Week 52
NCT01106690 (8) [back to overview]Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26
NCT01106690 (8) [back to overview]Change in HbA1c From Baseline to Week 26
NCT01106690 (8) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
NCT01106690 (8) [back to overview]Change in Systolic Blood Pressure (SBP) From Baseline to Week 26
NCT01106690 (8) [back to overview]Percentage of Patients With HbA1c <7% at Week 26
NCT01106690 (8) [back to overview]Percent Change in Triglycerides From Baseline to Week 26
NCT01106690 (8) [back to overview]Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
NCT01106690 (8) [back to overview]Percent Change in Body Weight From Baseline to Week 26
NCT01137812 (7) [back to overview]Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52
NCT01137812 (7) [back to overview]Percent Change in Body Weight From Baseline to Week 52
NCT01137812 (7) [back to overview]Change in Systolic Blood Pressure (SBP) From Baseline to Week 52
NCT01137812 (7) [back to overview]Change in HbA1c From Baseline to Week 52
NCT01137812 (7) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
NCT01137812 (7) [back to overview]Percentage of Patients With HbA1c <7% at Week 52
NCT01137812 (7) [back to overview]Percent Change in Triglycerides From Baseline to Week 52
NCT01340664 (4) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18
NCT01340664 (4) [back to overview]Percentage of Patients With HbA1c <7% at Week 18
NCT01340664 (4) [back to overview]Change in HbA1c From Baseline to Week 18
NCT01340664 (4) [back to overview]Percent Change in Body Weight From Baseline to Week 18
NCT01381900 (5) [back to overview]Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18
NCT01381900 (5) [back to overview]Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18
NCT01381900 (5) [back to overview]Percent Change in Body Weight From Baseline to Week 18
NCT01381900 (5) [back to overview]Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18
NCT01381900 (5) [back to overview]Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18
NCT01809327 (7) [back to overview]Change in Systolic Blood Pressure From Baseline at Week 26
NCT01809327 (7) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs)
NCT01809327 (7) [back to overview]Percent Change in Body Weight From Baseline to Week 26
NCT01809327 (7) [back to overview]Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26
NCT01809327 (7) [back to overview]Percent Change in Triglycerides From Baseline to Week 26
NCT01809327 (7) [back to overview]Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26
NCT01809327 (7) [back to overview]Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26
NCT01939496 (15) [back to overview]Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2
NCT01939496 (15) [back to overview]Change From Baseline in Body Weight to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6
NCT01939496 (15) [back to overview]Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6
NCT01989754 (3) [back to overview]Progression of Albuminuria
NCT01989754 (3) [back to overview]Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure
NCT01989754 (3) [back to overview]Cardiovascular (CV) Death
NCT02025907 (5) [back to overview]Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
NCT02025907 (5) [back to overview]Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26
NCT02025907 (5) [back to overview]Percent Change From Baseline in Body Weight at Week 26
NCT02025907 (5) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
NCT02025907 (5) [back to overview]Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
NCT02065791 (8) [back to overview]Cardiovascular (CV) Death
NCT02065791 (8) [back to overview]Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)
NCT02065791 (8) [back to overview]CV Composite Endpoint
NCT02065791 (8) [back to overview]Hospitalized Heart Failure (HHF)
NCT02065791 (8) [back to overview]Major Adverse Cardiac Event (MACE)
NCT02065791 (8) [back to overview]Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death
NCT02065791 (8) [back to overview]All-cause Mortality
NCT02065791 (8) [back to overview]Renal Composite Endpoint
NCT02139943 (2) [back to overview]Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight
NCT02139943 (2) [back to overview]Percentage of Participants With Adverse Events
NCT02220907 (4) [back to overview]Change From Baseline in Fasting Plasma Glucose Level
NCT02220907 (4) [back to overview]Percentage Change in Body Weight From Baseline
NCT02220907 (4) [back to overview]Number of Participants With Adverse Events
NCT02220907 (4) [back to overview]Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
NCT02220920 (5) [back to overview]"Percentage of Participants With Adverse Events and Hypoglycemia and Blood Glucose Decreased"
NCT02220920 (5) [back to overview]Change in Blood Pressure
NCT02220920 (5) [back to overview]Change in Fasting Plasma Glucose
NCT02220920 (5) [back to overview]Change in HbA1c From Baseline
NCT02220920 (5) [back to overview]Percent Change in Body Weight
NCT02227849 (5) [back to overview]Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
NCT02227849 (5) [back to overview]Change in Blood Pressure
NCT02227849 (5) [back to overview]Percentage Change in Body Weight
NCT02227849 (5) [back to overview]Change in Percentage of HbA1c
NCT02227849 (5) [back to overview]Change in Fasting Plasma Glucose
NCT02243202 (7) [back to overview]Change From Baseline in Systolic Blood Pressure at Week 26
NCT02243202 (7) [back to overview]Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
NCT02243202 (7) [back to overview]Absolute Change From Baseline in Body Weight at Week 26
NCT02243202 (7) [back to overview]Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
NCT02243202 (7) [back to overview]Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26
NCT02243202 (7) [back to overview]Change From Baseline in Pulse Rate at Week 26
NCT02243202 (7) [back to overview]Percent Change From Baseline in Body Weight at Week 26
NCT02324842 (8) [back to overview]Change in 24-hour Blood Pressure at Study End Compared to Baseline.
NCT02324842 (8) [back to overview]HbA1c at 4 Months
NCT02324842 (8) [back to overview]Fasting Plasma Glucose (FPG) at 4 Months
NCT02324842 (8) [back to overview]Change in Total Body Weight at Study End Compared to Baseline
NCT02324842 (8) [back to overview]Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline
NCT02324842 (8) [back to overview]Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)
NCT02324842 (8) [back to overview]Change in Free Plasma Insulin at the End of the Study From Baseline Value
NCT02324842 (8) [back to overview]Body Mass Index (BMI) at 4 Months
NCT02354222 (5) [back to overview]Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
NCT02354222 (5) [back to overview]Percentage Change in Body Weight From Baseline
NCT02354222 (5) [back to overview]Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)
NCT02354222 (5) [back to overview]Change From Baseline in Fasting Plasma Glucose Level
NCT02354222 (5) [back to overview]Change From Baseline in 2-hour Postprandial Plasma Glucose Level
NCT02354235 (5) [back to overview]Percentage Change in Body Weight From Baseline
NCT02354235 (5) [back to overview]Change From Baseline in 2-hour Postprandial Plasma Glucose Level
NCT02354235 (5) [back to overview]Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)
NCT02354235 (5) [back to overview]Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
NCT02354235 (5) [back to overview]Change From Baseline in Fasting Plasma Glucose Level
NCT02360774 (4) [back to overview]Change in Body Composition, Measured Using DXA Scanning.
NCT02360774 (4) [back to overview]Change in Body Weight
NCT02360774 (4) [back to overview]Change in Glycemic Control
NCT02360774 (4) [back to overview]Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery
NCT02462421 (6) [back to overview]Canagliflozin-induced Change in Urinary Excretion of Sodium
NCT02462421 (6) [back to overview]Change in Fractional Excretion of Uric Acid (the Difference Between Data After Administration of Canagliflozin Minus Data Before Administration of Canagliflozin)
NCT02462421 (6) [back to overview]Urinary Excretion of Glucose (Measured During the 24 Hours Following Administration of Canagliflozin)
NCT02462421 (6) [back to overview]Canagliflozin-induced Change in Serum Creatinine
NCT02462421 (6) [back to overview]Canagliflozin-induced Change in Fasting Plasma Glucose
NCT02462421 (6) [back to overview]Canagliflozin-induced Change in Serum Uric Acid
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]Change From Baseline in Body Weight at 24 Weeks
NCT02597049 (11) [back to overview]Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks
NCT02597049 (11) [back to overview]Number of Participants With Adjudicated Cardiovascular (CV) Events
NCT02597049 (11) [back to overview]Percentage of Participants With HbA1c <7%
NCT02597049 (11) [back to overview]Rate of Hypoglycemic Events Adjusted Per 30 Days
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)
NCT02597049 (11) [back to overview]Change From Baseline in Fasting Glucagon at 24 Weeks
NCT02597049 (11) [back to overview]Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia
NCT02597049 (11) [back to overview]Number of Participants With Adjudicated Acute Pancreatitis Events
NCT02622113 (4) [back to overview]Percentage Change in Body Weight
NCT02622113 (4) [back to overview]Change in Percentage of HbA1c
NCT02622113 (4) [back to overview]Change in Fasting Plasma Glucose
NCT02622113 (4) [back to overview]Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
NCT02673138 (4) [back to overview]Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion
NCT02673138 (4) [back to overview]Differences in Plasma Glucose Levels Following the Interruption of Basal Subcutaneous Infusion of Insulin
NCT02673138 (4) [back to overview]Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal
NCT02673138 (4) [back to overview]Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion
NCT02912455 (17) [back to overview]Change at Six Months Versus Baseline in Hemoglobin A1c Value (%)
NCT02912455 (17) [back to overview]Change in Adiponectin Levels at 6 Months Compared to Randomization
NCT02912455 (17) [back to overview]Change in Body Weight at Six Months Compared to Baseline
NCT02912455 (17) [back to overview]Change in CRP Levels at 6 Months Compared to Baseline
NCT02912455 (17) [back to overview]Change in Diastolic Blood Pressure at Six Months Compared to Baseline
NCT02912455 (17) [back to overview]Change in Fasting Glucose From Randomization
NCT02912455 (17) [back to overview]Change in Percentage of Truncal Fat
NCT02912455 (17) [back to overview]Change in Spine Bone Mineral Density
NCT02912455 (17) [back to overview]Change in Percentage of Lean Mass
NCT02912455 (17) [back to overview]Change in Percentage of Gynoid Fat
NCT02912455 (17) [back to overview]Change in Percentage of Android Fat
NCT02912455 (17) [back to overview]Change in Percent Body Fat as Measured by DEXA Scan at 6 Months Compared to Randomization
NCT02912455 (17) [back to overview]Change in Leptin Levels at 6 Months Compared to Baseline
NCT02912455 (17) [back to overview]Number of Participants Who Reported Hypoglycemia From Each Group (at a Frequency of 1 Episode)
NCT02912455 (17) [back to overview]Change in Leg Bone Mineral Density
NCT02912455 (17) [back to overview]Change in Total Cholesterol
NCT02912455 (17) [back to overview]Change in Systolic Blood Pressure at 6 Months Compared to Baseline
NCT02920918 (2) [back to overview]Change From Baseline Ventilatory Efficiency at 12 Weeks
NCT02920918 (2) [back to overview]Change From Baseline Aerobic Exercise Capacity at 12 Weeks
NCT02964585 (18) [back to overview]Glycemic Control
NCT02964585 (18) [back to overview]Glycemic Control (HbA1C)
NCT02964585 (18) [back to overview]Microalbumin
NCT02964585 (18) [back to overview]Pulse Wave Velocity
NCT02964585 (18) [back to overview]Resting Metabolic Rate (RMR)
NCT02964585 (18) [back to overview]Serum Endothelial Inflammatory Markers (2)
NCT02964585 (18) [back to overview]Augmentation Index (Pulse Wave Analysis)
NCT02964585 (18) [back to overview]Body Fat Percentage
NCT02964585 (18) [back to overview]eGFR
NCT02964585 (18) [back to overview]Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Proliferation)
NCT02964585 (18) [back to overview]Fasting Lipid Profile
NCT02964585 (18) [back to overview]Creatinine (Urine)
NCT02964585 (18) [back to overview]BMI
NCT02964585 (18) [back to overview]Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Counts)
NCT02964585 (18) [back to overview]Serum Endothelial Inflammatory Markers (1)
NCT02964585 (18) [back to overview]Kidney Function Markers
NCT02964585 (18) [back to overview]Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)
NCT02964585 (18) [back to overview]Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Percentages)
NCT03136484 (61) [back to overview]Change in Total Fat Mass (kg)
NCT03136484 (61) [back to overview]Change in SMPG- Mean Postprandial Increment Over All Meals
NCT03136484 (61) [back to overview]Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile
NCT03136484 (61) [back to overview]Change in SF-36: Physical Component Summary (PCS)
NCT03136484 (61) [back to overview]Change in SF-36: Mental Component Summary (MCS)
NCT03136484 (61) [back to overview]Change in Ratio Between Total Fat Mass and Total Lean Mass
NCT03136484 (61) [back to overview]Change in Pulse
NCT03136484 (61) [back to overview]Participants Who Achieved Weight Loss ≥5% (Yes/no)
NCT03136484 (61) [back to overview]Participants Who Achieved Weight Loss ≥3% (Yes/no)
NCT03136484 (61) [back to overview]Participants Who Achieved Weight Loss ≥10% (Yes/no)
NCT03136484 (61) [back to overview]Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no)
NCT03136484 (61) [back to overview]Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no)
NCT03136484 (61) [back to overview]Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no)
NCT03136484 (61) [back to overview]Participants Who Achieved HbA1c Reduction ≥1% (Yes/no)
NCT03136484 (61) [back to overview]Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no)
NCT03136484 (61) [back to overview]Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no)
NCT03136484 (61) [back to overview]Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no)
NCT03136484 (61) [back to overview]Change in Haematological Parameter- Leukocytes
NCT03136484 (61) [back to overview]Change in Haematological Parameter- Haemoglobin
NCT03136484 (61) [back to overview]Change in Haematological Parameter- Haematocrit
NCT03136484 (61) [back to overview]Change in Haematological Parameter- Erythrocytes
NCT03136484 (61) [back to overview]Change in FPG (Fasting Plasma Glucose)
NCT03136484 (61) [back to overview]Change in Fasting Triglycerides
NCT03136484 (61) [back to overview]Change in Fasting Total Cholesterol
NCT03136484 (61) [back to overview]Change in Fasting LDL-cholesterol
NCT03136484 (61) [back to overview]Change in Fasting HDL-cholesterol
NCT03136484 (61) [back to overview]Change in Calcitonin
NCT03136484 (61) [back to overview]Change in Body Weight (kg)
NCT03136484 (61) [back to overview]Change in Body Mass Index (BMI)
NCT03136484 (61) [back to overview]Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure)
NCT03136484 (61) [back to overview]Change in Short Form 36 Health Survey (SF-36): Sub-domains
NCT03136484 (61) [back to overview]Change in Physical Examination
NCT03136484 (61) [back to overview]Change in HbA1c
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- Total Bilirubin
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- Sodium
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- Potassium
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- Lipase
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- eGFR
NCT03136484 (61) [back to overview]Change in Haematological Parameter- Thrombocytes
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- Calcium
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- AST
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- Amylase
NCT03136484 (61) [back to overview]Change in ECG
NCT03136484 (61) [back to overview]Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately
NCT03136484 (61) [back to overview]Change in Control of Eating Questionnaire (CoEQ): Domains
NCT03136484 (61) [back to overview]Change in CoEQ: Individual Items
NCT03136484 (61) [back to overview]Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
NCT03136484 (61) [back to overview]Total Number of Treatment Emergent Adverse Events (TEAEs)
NCT03136484 (61) [back to overview]Percentage Change in Visceral Fat Mass (%)
NCT03136484 (61) [back to overview]Percentage Change in Total Lean Mass (%)
NCT03136484 (61) [back to overview]Percentage Change in Total Fat Mass (%)
NCT03136484 (61) [back to overview]Eye Examination
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- ALT
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- ALP
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- Albumin
NCT03136484 (61) [back to overview]Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
NCT03136484 (61) [back to overview]Change in Waist Circumference
NCT03136484 (61) [back to overview]Change in Visceral Fat Mass (kg)
NCT03136484 (61) [back to overview]Percentage Change in Body Weight (%)
NCT03136484 (61) [back to overview]Change in Total Lean Mass (kg)
NCT03136484 (61) [back to overview]Change in Biochemistry Parameter- Creatinine
NCT03267576 (15) [back to overview]Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL
NCT03267576 (15) [back to overview]Change From Baseline in Time Spent With Glucose Level < 70 mg/dL
NCT03267576 (15) [back to overview]Change From Baseline in Time Spent With Glucose Level > 140 mg/dL
NCT03267576 (15) [back to overview]Change From Baseline in Time Spent With Glucose Level > 180 mg/dL
NCT03267576 (15) [back to overview]Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL
NCT03267576 (15) [back to overview]Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL
NCT03267576 (15) [back to overview]Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL
NCT03267576 (15) [back to overview]Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL
NCT03267576 (15) [back to overview]Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL
NCT03267576 (15) [back to overview]Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1
NCT03267576 (15) [back to overview]Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2
NCT03267576 (15) [back to overview]Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels
NCT03267576 (15) [back to overview]Change From Baseline in Fasting Plasma Glucose Levels
NCT03267576 (15) [back to overview]Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile
NCT03267576 (15) [back to overview]Change From Baseline in Mean 24-hour Glucose Profile
NCT04252287 (5) [back to overview]Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12
NCT04252287 (5) [back to overview]Change From Baseline in KCCQ Clinical Summary Score at Week 12
NCT04252287 (5) [back to overview]Change From Baseline in KCCQ Overall Summary Score at Week 12
NCT04252287 (5) [back to overview]Change From Baseline in Total Daily Step Count at Week 12
NCT04252287 (5) [back to overview]Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12
NCT04288778 (4) [back to overview]Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
NCT04288778 (4) [back to overview]Percentage of Participants With Unexpected Adverse Events (AEs)
NCT04288778 (4) [back to overview]Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
NCT04288778 (4) [back to overview]Percentage of Participants With Adverse Drug Reactions (ADRs)

Percent Change in Body Weight From Baseline to Week 12

The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change. (NCT00642278)
Timeframe: Day 1 (Baseline) and Week 12

InterventionPercent change (Mean)
Placebo-1.1
Canagliflozin 50 mg Daily-2.3
Canagliflozin 100 mg Daily-2.6
Canagliflozin 200 mg Daily-2.7
Canagliflozin 300 mg Daily-3.4
Canagliflozin 300 mg Twice Daily-3.4
Sitagliptin 100 mg Daily-0.6

[back to top]

Absolute Change in Body Weight From Baseline to Week 12

The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group. (NCT00642278)
Timeframe: Day 1 (Baseline) and Week 12

Interventionkg (Mean)
Placebo-0.78
Canagliflozin 50 mg Daily-1.96
Canagliflozin 100 mg Daily-2.25
Canagliflozin 200 mg Daily-2.32
Canagliflozin 300 mg Daily-2.88
Canagliflozin 300 mg Twice Daily-2.87
Sitagliptin 100 mg Daily-0.43

[back to top]

Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12

The table below shows the mean change in overnight urine glucose/creatinine ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change. (NCT00642278)
Timeframe: Day 1 (Baseline) and Week 12

Interventionmg/mg (Mean)
Placebo1.9
Canagliflozin 50 mg Daily35.4
Canagliflozin 100 mg Daily51.5
Canagliflozin 200 mg Daily50.5
Canagliflozin 300 mg Daily49.4
Canagliflozin 300 mg Twice Daily61.6
Sitagliptin 100 mg Daily-1.9

[back to top]

Change in HbA1c From Baseline to Week 12

The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change. (NCT00642278)
Timeframe: Day 1 (Baseline) and Week 12

InterventionPercent (Mean)
Placebo-0.22
Canagliflozin 50 mg Daily-0.79
Canagliflozin 100 mg Daily-0.76
Canagliflozin 200 mg Daily-0.70
Canagliflozin 300 mg Daily-0.92
Canagliflozin 300 mg Twice Daily-0.95
Sitagliptin 100 mg Daily-0.74

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12

The table below shows the mean change in FPG from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change. (NCT00642278)
Timeframe: Day 1 (Baseline) and Week 12

Interventionmmol/L (Mean)
Placebo0.2
Canagliflozin 50 mg Daily-0.9
Canagliflozin 100 mg Daily-1.4
Canagliflozin 200 mg Daily-1.5
Canagliflozin 300 mg Daily-1.4
Canagliflozin 300 mg Twice Daily-1.3
Sitagliptin 100 mg Daily-0.7

[back to top]

Percentage of Patients With Symptoms of Hypoglycemia

The table below shows the percentage of patients who experienced symptomatic hypoglycemic events between Baseline and Week 12. (NCT00642278)
Timeframe: Up to Week 12

InterventionPercentage of patients (Number)
Placebo2
Canagliflozin 50 mg Daily0
Canagliflozin 100 mg Daily2
Canagliflozin 200 mg Daily6
Canagliflozin 300 mg Daily0
Canagliflozin 300 mg Twice Daily3
Sitagliptin 100 mg Daily5

[back to top]

Change in Waist Circumference From Baseline to Week 12

The table below shows the mean change in waist circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change. (NCT00650806)
Timeframe: Day 1 (Baseline) and Week 12

Interventioncm (Mean)
Placebo-1.2
Canagliflozin 50 mg-1.4
Canagliflozin 100 mg-2.9
Canagliflozin 300 mg-2.6

[back to top]

Change in Hip Circumference From Baseline to Week 12

The table below shows the mean change in hip circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change. (NCT00650806)
Timeframe: Day 1 (Baseline) and Week 12

Interventioncm (Mean)
Placebo0.1
Canaglifozin 50 mg-2.0
Canagliflozin 100 mg-2.1
Canagliflozin 300 mg-3.0

[back to top]

Change in Body Mass Index (BMI) From Baseline to Week 12

The table below shows the mean change in BMI from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change. (NCT00650806)
Timeframe: Day 1 (Baseline) and Week 12

Interventionkg/m2 (Mean)
Placebo-0.4
Canagliflozin 50 mg-0.7
Canagliflozin 100 mg-1.0
Canagliflozin 300 mg-0.9

[back to top]

Absolute Change in Body Weight From Baseline to Week 12

The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change. (NCT00650806)
Timeframe: Day 1 (Baseline) and Week 12

Interventionkg (Mean)
Placebo-1.1
Canagliflozin 50 mg-1.9
Canagliflozin 100 mg-2.8
Canagliflozin 300 mg-2.4

[back to top]

Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12

The table below shows the percentage of patients who lost at least 5% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo). (NCT00650806)
Timeframe: Day 1 (Baseline) and Week 12

InterventionPercentage of patients (Number)
Placebo8.1
Canagliflozin 50 mg12.6
Canagliflozin 100 mg18.8
Canagliflozin 300 mg17.2

[back to top]

Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12

The table below shows the percentage of patients who lost at least 10% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo). (NCT00650806)
Timeframe: Day 1 (Baseline) and Week 12

InterventionPercentage of patients (Number)
Placebo0.0
Canagliflozin 50 mg3.2
Canagliflozin 100 mg2.4
Canagliflozin 300 mg1.1

[back to top]

Percent Change in Body Weight From Baseline to Week 12

The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean percent change. (NCT00650806)
Timeframe: Day 1 (Baseline) and Week 12

InterventionPercent change (Mean)
Placebo-1.1
Canagliflozin 50 mg-2.0
Canagliflozin 100 mg-2.8
Canaglifloziin 300 mg-2.5

[back to top]

Change in Waist/Hip Ratio From Baseline to Week 12

The table below shows the mean change in waist/hip ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change. (NCT00650806)
Timeframe: Day 1 (Baseline) and Week 12

Interventionratio (Mean)
Placebo-0.011
Canaglifozin 50 mg0.003
Canagliflozin 100 mg-0.008
Canagliflozin 300 mg-0.004

[back to top]

Change in HbA1c From Baseline to Week 104

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change. (NCT00968812)
Timeframe: Baseline, Week 104

InterventionPercent (Least Squares Mean)
Canagliflozin 100 mg-0.65
Canagliflozin 300 mg-0.74
Glimepiride-0.55

[back to top]

Change in HbA1c From Baseline to Week 52

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercent (Least Squares Mean)
Canagliflozin 100 mg-0.82
Canagliflozin 300 mg-0.93
Glimepiride-0.81

[back to top]

Percent Change in Body Weight From Baseline to Week 52

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercent change (Least Squares Mean)
Canagliflozin 100 mg-4.2
Canagliflozin 300 mg-4.7
Glimepiride1.0

[back to top]

Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52

The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages. (NCT00968812)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercentage of patients (Number)
Canagliflozin 100 mg5.6
Canagliflozin 300 mg4.9
Glimepiride34.2

[back to top]

Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT)

The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100 percent. (NCT01032629)
Timeframe: Baseline and end of treatment (approximately 338 weeks)

InterventionPercentage of HOMA2 (Least Squares Mean)
Placebo4.02
Canagliflozin 100 mg6.82
Canagliflozin 300 mg8.09

[back to top]

Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment

Change from baseline in glycated hemoglobin (HbA1c) percentage (%) was assessed at end of treatment. Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average glucose concentration in the blood. (NCT01032629)
Timeframe: Baseline and end of treatment (approximately 338 weeks)

InterventionHbA1c (%) (Least Squares Mean)
Placebo0.01
Canagliflozin 100 mg-0.26
Canagliflozin 300 mg-0.31

[back to top]

Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment

Change from baseline in the fasting plasma glucose levels at end-of-treatment was assessed. (NCT01032629)
Timeframe: Baseline and end of treatment (approximately 338 weeks)

InterventionMillimoles per liter (mmol/L) (Least Squares Mean)
Placebo0.16
Canagliflozin 100 mg-0.42
Canagliflozin 300 mg-0.57

[back to top]

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment

Change from baseline in Estimated Glomerular Filtration Rate (eGFR) was assessed at end of treatment. GFR is a measure of the rate at which blood is filtered by the kidney. Modification of Diet in Renal Disease (MDRD) is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and sex. eGFR milliliters/minute/1.73 meters square (mL/min/1.73 m^2) = 175 * (serum creatinine) ^ 1.154 * (Age) ^-0.203 *(0.742 if female) * (1.21 if Black). (NCT01032629)
Timeframe: Baseline and end of treatment (approximately 338 weeks)

InterventionmL/min/1.73 m^2 (Least Squares Mean)
Placebo-5.23
Canagliflozin 100 mg-3.55
Canagliflozin 300 mg-3.98

[back to top]

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment

Change from baseline in systolic blood pressure and diastolic blood pressure was assessed. (NCT01032629)
Timeframe: Baseline and end of treatment (approximately 338 weeks)

,,
InterventionMillimeter of mercury (mmHg) (Least Squares Mean)
SBP(Change at end of treatment)DBP (Change at end of treatment)
Canagliflozin 100 mg-4.91-3.70
Canagliflozin 300 mg-6.49-4.51
Placebo-1.96-2.88

[back to top]

Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment

Change from baseline in cholesterol, high-density lipoprotein cholesterol and low density lipoprotein cholesterol levels were assessed. (NCT01032629)
Timeframe: Baseline and end of treatment (approximately 338 weeks)

,,
Interventionmmol/L (Least Squares Mean)
Cholesterol (change at EOT)HDL-C (change at EOT)LDL-C (change at EOT)
Canagliflozin 100 mg0.110.040.04
Canagliflozin 300 mg0.160.050.10
Placebo-0.07-0.01-0.07

[back to top]

Percentage of Participants With Progression of Albuminuria at the End-of-Treatment

Progression defined as the development of micro-albuminuria (albumin/creatinine ratio (ACR) greater than or equal to [>=] 30 milligram per gram (mg/g) and less than or equal to <= 300 mg/g) or macroalbuminuria (ACR of >300 mg/g) in a participant with baseline normoalbuminuria or the development of macro-albuminuria in a participant with baseline microalbuminuria. Percentage of participants with progression of albuminuria at the end-of-treatment were assessed. (NCT01032629)
Timeframe: End of treatment (approximately 338 weeks)

InterventionPercentage of participants (Number)
Placebo24.0
Canagliflozin 100 mg20.2
Canagliflozin 300 mg18.3

[back to top]

Percent Change From Baseline in Body Weight at End-of-Treatment

Percent change from baseline in body weight was assessed at the end of treatment. (NCT01032629)
Timeframe: Baseline and end of treatment (approximately 338 weeks)

InterventionPercent change (Least Squares Mean)
Placebo-0.50
Canagliflozin 100 mg-3.47
Canagliflozin 300 mg-4.12

[back to top]

Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke

MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented. (NCT01032629)
Timeframe: Up to approximately 8 years

InterventionEvents per 1000 patient-year (Number)
Placebo30.36
Canagliflozin 100 mg28.41
Canagliflozin 300 mg25.37
Canagliflozin (Total)26.89

[back to top]

Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment

Urinary Albumin/Creatinine Ratio is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. (NCT01032629)
Timeframe: Baseline and End of treatment (approximately 338 weeks)

InterventionMilligram per gram (mg/g) (Geometric Mean)
Placebo29.30
Canagliflozin 100 mg25.50
Canagliflozin 300 mg24.47

[back to top]

Change From Baseline in Triglycerides Levels at End-of-Treatment

Change from baseline in triglycerides levels was assessed. (NCT01032629)
Timeframe: Baseline and end of treatment (approximately 338 weeks)

Interventionmmol/L (Mean)
Placebo0.05
Canagliflozin 100 mg0.13
Canagliflozin 300 mg0.09

[back to top]

Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment

A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion. (NCT01032629)
Timeframe: Baseline and end of treatment (approximately 338 weeks)

InterventionPicomole per milli international units (Least Squares Mean)
Placebo0.70
Canagliflozin 100 mg0.67
Canagliflozin 300 mg1.03

[back to top]

Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment

Change from baseline in LDL-C to HDL-C ratio was assessed. (NCT01032629)
Timeframe: Baseline and end of treatment (approximately 338 weeks)

InterventionRatio (Least Squares Mean)
Placebo-0.04
Canagliflozin 100 mg-0.02
Canagliflozin 300 mg0.00

[back to top]

Change in HbA1c From Baseline to Week 26

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01064414)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent (Least Squares Mean)
Placebo-0.03
Canagliflozin 100 mg-0.33
Canagliflozin 300 mg-0.44

[back to top]

Percentage of Patients With HbA1c <7% at Week 26

The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01064414)
Timeframe: Week 26

InterventionPercentage of patients (Number)
Placebo17.2
Canagliflozin 100 mg27.3
Canagliflozin 300 mg32.6

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01064414)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmg/dL (Least Squares Mean)
Placebo0.49
Canagliflozin 100 mg-14.9
Canagliflozin 300 mg-11.7

[back to top]

Change in HbA1c From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent (Least Squares Mean)
Placebo0.14
Canagliflozin 100 mg-0.77
Canagliflozin 300 mg-1.03

[back to top]

Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmg/dL (Least Squares Mean)
Canagliflozin 100 mg-118
Canagliflozin 300 mg-126

[back to top]

Percent Change in Body Weight From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo-0.6
Canagliflozin 100 mg-2.8
Canagliflozin 300 mg-3.9

[back to top]

Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Canagliflozin 100 mg-3.0
Canagliflozin 300 mg-3.8

[back to top]

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

InterventionmmHg (Least Squares Mean)
Placebo0.38
Canagliflozin 100 mg-3.34
Canagliflozin 300 mg-5.04

[back to top]

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

InterventionmmHg (Least Squares Mean)
Canagliflozin 100 mg-4.47
Canagliflozin 300 mg-4.97

[back to top]

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Canagliflozin 100 mg2.4
Canagliflozin 300 mg10.8

[back to top]

Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent (Least Squares Mean)
Canagliflozin 100 mg-2.13
Canagliflozin 300 mg-2.56

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmg/dL (Least Squares Mean)
Placebo8.33
Canagliflozin 100 mg-27.2
Canagliflozin 300 mg-35.0

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmg/dL (Least Squares Mean)
Canagliflozin 100 mg-81.7
Canagliflozin 300 mg-86.3

[back to top]

Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmg/dL (Least Squares Mean)
Placebo5.19
Canagliflozin 100 mg-42.9
Canagliflozin 300 mg-58.8

[back to top]

Percentage of Patients With HbA1c <7% at Week 26 (Main Study)

The table below shows the percentage of patients with HbA1c <7% at Week 26. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01081834)
Timeframe: Week 26

InterventionPercentage of patients (Number)
Placebo20.6
Canagliflozin 100 mg44.5
Canagliflozin 300 mg62.4

[back to top]

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo4.4
Canagliflozin 100 mg11.2
Canagliflozin 300 mg10.5

[back to top]

Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)

The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Canagliflozin 100 mg-0.6
Canagliflozin 300 mg-12.7

[back to top]

Percent Change in Triglycerides From Baseline to Week 26 (Main Study)

The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01081834)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo7.8
Canagliflozin 100 mg2.5
Canagliflozin 300 mg-2.4

[back to top]

Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)

The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy. (NCT01081834)
Timeframe: Week 26

InterventionPercentage of patients (Number)
Canagliflozin 100 mg17.4
Canagliflozin 300 mg11.6

[back to top]

Percent Change in Triglycerides From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo11.6
Canagliflozin 100 mg5.4
Canagliflozin 300 mg8.5

[back to top]

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo3.2
Canagliflozin 100 mg5.7
Canagliflozin 300 mg6.5

[back to top]

Percent Change in Body Weight From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo-0.7
Canagliflozin 100 mg-2.1
Canagliflozin 300 mg-2.6

[back to top]

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26

InterventionmmHg (Least Squares Mean)
Placebo-2.65
Canagliflozin 100 mg-4.89
Canagliflozin 300 mg-4.27

[back to top]

Percentage of Patients With HbA1c <7% at Week 26

The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01106625)
Timeframe: Week 26

InterventionPercentage of patients (Number)
Placebo18
Canagliflozin 100 mg43.2
Canagliflozin 300 mg56.6

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmg/dL (Least Squares Mean)
Placebo4.11
Canagliflozin 100 mg-18.2
Canagliflozin 300 mg-30.5

[back to top]

Change in HbA1c From Baseline to Week 26

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106625)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent (Least Squares Mean)
Placebo-0.13
Canagliflozin 100 mg-0.85
Canagliflozin 300 mg-1.06

[back to top]

Change in HbA1c From Baseline to Week 26

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent (Least Squares Mean)
Placebo-0.03
Canagliflozin 100 mg-0.60
Canagliflozin 300 mg-0.73

[back to top]

Percent Change in Body Weight From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo-0.1
Canagliflozin 100 mg-2.4
Canagliflozin 300 mg-3.1

[back to top]

Percentage of Patients With HbA1c <7% at Week 26

The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01106651)
Timeframe: Week 26

InterventionPercentage of patients (Number)
Placebo28.0
Canagliflozin 100 mg47.7
Canagliflozin 300 mg58.5

[back to top]

Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Interventionkg (Least Squares Mean)
Placebo-0.28
Canagliflozin 100 mg-1.87
Canagliflozin 300 mg-2.38

[back to top]

Percent Change in Triglycerides From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo7.7
Canagliflozin 100 mg2.8
Canagliflozin 300 mg8.4

[back to top]

Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo-0.5
Canagliflozin 100 mg-0.9
Canagliflozin 300 mg-1.0

[back to top]

Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo0.5
Canagliflozin 100 mg0.7
Canagliflozin 300 mg0.2

[back to top]

Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo-1.0
Canagliflozin 100 mg-0.7
Canagliflozin 300 mg-0.6

[back to top]

Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo-0.5
Canagliflozin 100 mg-0.7
Canagliflozin 300 mg-0.8

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmg/dL (Least Squares Mean)
Placebo7.39
Canagliflozin 100 mg-18.1
Canagliflozin 300 mg-20.3

[back to top]

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo1.5
Canagliflozin 100 mg6.8
Canagliflozin 300 mg6.2

[back to top]

Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent (Least Squares Mean)
Placebo0.02
Canagliflozin 100 mg-1.04
Canagliflozin 300 mg-1.18

[back to top]

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionmmHg (Least Squares Mean)
Placebo1.10
Canagliflozin 100 mg-3.52
Canagliflozin 300 mg-6.79

[back to top]

Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition

Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106651)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent (Least Squares Mean)
Placebo0.00
Canagliflozin 100 mg-1.03
Canagliflozin 300 mg-1.18

[back to top]

Change in 2-hour Post-prandial Glucose From Baseline to Week 26

The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmg/dL (Least Squares Mean)
Placebo/Sitagliptin-9.79
Canagliflozin 100 mg-47.9
Canagliflozin 300 mg-57.1
Sitagliptin 100 mg-49.3

[back to top]

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Sitagliptin3.7
Canagliflozin 100 mg10.4
Canagliflozin 300 mg12.1
Sitagliptin 100 mg5.0

[back to top]

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52

The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercent change (Least Squares Mean)
Canagliflozin 100 mg11.2
Canagliflozin 300 mg13.3
Sitagliptin 100 mg6.0

[back to top]

Percent Change in Triglycerides From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Sitagliptin3.2
Canagliflozin 100 mg1.6
Canagliflozin 300 mg-1.4
Sitagliptin 100 mg1.0

[back to top]

Change in Systolic Blood Pressure (SBP) From Baseline to Week 52

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

InterventionmmHg (Least Squares Mean)
Canagliflozin 100 mg-3.53
Canagliflozin 300 mg-4.65
Sitagliptin 100 mg-0.66

[back to top]

Percentage of Patients With HbA1c <7% at Week 26

The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences between each canagliflozin or sitagliptin group and placebo. (NCT01106677)
Timeframe: Week 26

InterventionPercentage of patients (Number)
Placebo/Sitagliptin29.8
Canagliflozin 100 mg45.5
Canagliflozin 300 mg57.8
Sitagliptin 100 mg54.5

[back to top]

Change in HbA1c From Baseline to Week 52

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercent (Least Squares Mean)
Canagliflozin 100 mg-0.73
Canagliflozin 300 mg-0.88
Sitagliptin 100 mg-0.73

[back to top]

Percent Change in Body Weight From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Sitagliptin-1.2
Canagliflozin 100 mg-3.7
Canagliflozin 300 mg-4.2
Sitagliptin 100 mg-1.2

[back to top]

Percent Change in Body Weight From Baseline to Week 52

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercent change (Least Squares Mean)
Canagliflozin 100 mg-3.8
Canagliflozin 300 mg-4.2
Sitagliptin 100 mg-1.3

[back to top]

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

InterventionmmHg (Least Squares Mean)
Placebo/Sitagliptin1.52
Canagliflozin 100 mg-3.84
Canagliflozin 300 mg-5.06
Sitagliptin 100 mg-1.83

[back to top]

Change in HbA1c From Baseline to Week 26

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent (Least Squares Mean)
Placebo/Sitagliptin-0.17
Canagliflozin 100 mg-0.79
Canagliflozin 300 mg-0.94
Sitagliptin 100 mg-0.82

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

Interventionmg/dL (Least Squares Mean)
Canagliflozin 100 mg-26.2
Canagliflozin 300 mg-35.2
Sitagliptin 100 mg-17.7

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmg/dL (Least Squares Mean)
Placebo/Sitagliptin2.47
Canagliflozin 100 mg-27.3
Canagliflozin 300 mg-37.8
Sitagliptin 100 mg-20.2

[back to top]

Percent Change in Triglycerides From Baseline to Week 52

The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change. (NCT01106677)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercent change (Least Squares Mean)
Canagliflozin 100 mg1.9
Canagliflozin 300 mg2.7
Sitagliptin 100 mg-0.4

[back to top]

Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26

HOMA2-%B is a measure of beta cell function (the cells in the pancreas that produce and store insulin). The table below shows the least-squares (LS) mean change in HOMA2-%B from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106690)
Timeframe: Day 1 (Baseline) and Week 26

InterventionHOMA2-%B (Least Squares Mean)
Placebo/Sitagliptin0.91
Canagliflozin 100 mg15.19
Canagliflozin 300 mg18.14

[back to top]

Change in HbA1c From Baseline to Week 26

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106690)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent (Least Squares Mean)
Placebo/Sitagliptin-0.26
Canagliflozin 100 mg-0.89
Canagliflozin 300 mg-1.03

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106690)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmg/dL (Least Squares Mean)
Placebo/Sitagliptin2.54
Canagliflozin 100 mg-26.8
Canagliflozin 300 mg-33.2

[back to top]

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01106690)
Timeframe: Day 1 (Baseline) and Week 26

InterventionmmHg (Least Squares Mean)
Placebo/Sitagliptin-1.24
Canagliflozin 100 mg-5.30
Canagliflozin 300 mg-4.70

[back to top]

Percentage of Patients With HbA1c <7% at Week 26

The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01106690)
Timeframe: Week 26

InterventionPercentage of patients (Number)
Placebo/Sitagliptin32.5
Canagliflozin 100 mg46.9
Canagliflozin 300 mg64.3

[back to top]

Percent Change in Triglycerides From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01106690)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Sitagliptin15.2
Canagliflozin 100 mg3.2
Canagliflozin 300 mg-1.7

[back to top]

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01106690)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Sitagliptin2.4
Canagliflozin 100 mg7.2
Canagliflozin 300 mg8.9

[back to top]

Percent Change in Body Weight From Baseline to Week 26

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01106690)
Timeframe: Day 1 (Baseline) and Week 26

InterventionPercent change (Least Squares Mean)
Placebo/Sitagliptin-0.1
Canagliflozin 100 mg-2.8
Canagliflozin 300 mg-3.8

[back to top]

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52

The table below shows the mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercent change (Least Squares Mean)
Canagliflozin 300 mg7.6
Sitagliptin 100 mg0.6

[back to top]

Percent Change in Body Weight From Baseline to Week 52

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercent change (Least Squares Mean)
Canagliflozin 300 mg-2.5
Sitagliptin 100 mg0.3

[back to top]

Change in Systolic Blood Pressure (SBP) From Baseline to Week 52

The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

InterventionmmHg (Least Squares Mean)
Canagliflozin 300 mg-5.06
Sitagliptin 100 mg0.85

[back to top]

Change in HbA1c From Baseline to Week 52

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercent (Least Squares Mean)
Canagliflozin 300 mg-1.03
Sitagliptin 100 mg-0.66

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

Interventionmg/dL (Least Squares Mean)
Canagliflozin 300 mg-29.9
Sitagliptin 100 mg-5.85

[back to top]

Percentage of Patients With HbA1c <7% at Week 52

The table below shows the percentage of patients with HbA1c <7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage. (NCT01137812)
Timeframe: Week 52

InterventionPercentage of patients (Number)
Canagliflozin 300 mg47.6
Sitagliptin 100 mg35.3

[back to top]

Percent Change in Triglycerides From Baseline to Week 52

The table below shows the mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. (NCT01137812)
Timeframe: Day 1 (Baseline) and Week 52

InterventionPercent change (Least Squares Mean)
Canagliflozin 300 mg9.6
Sitagliptin 100 mg11.9

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01340664)
Timeframe: Day 1 (Baseline) and Week 18

Interventionmg/dL (Least Squares Mean)
Placebo8.1
Canagliflozin 50 mg Bid-15.5
Canagliflozin 150 mg Bid-15.9

[back to top]

Percentage of Patients With HbA1c <7% at Week 18

The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01340664)
Timeframe: Week 18

InterventionPercentage of Participants (Number)
Placebo31.5
Canagliflozin 50 mg Bid47.8
Canagliflozin 150 mg Bid57.1

[back to top]

Change in HbA1c From Baseline to Week 18

The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01340664)
Timeframe: Day 1 (Baseline) and Week 18

InterventionPercent (Least Squares Mean)
Placebo-0.01
Canagliflozin 50 mg Bid-0.45
Canagliflozin 150 mg Bid-0.61

[back to top]

Percent Change in Body Weight From Baseline to Week 18

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01340664)
Timeframe: Day 1 (Baseline) and Week 18

InterventionPercent change (Least Squares Mean)
Placebo-0.6
Canagliflozin 50 mg Bid-2.8
Canagliflozin 150 mg Bid-3.2

[back to top]

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18

The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01381900)
Timeframe: Day 1 (Baseline) and Week 18

Interventionmg/dL (Least Squares Mean)
Placebo-0.40
Canagliflozin 100 mg-1.44
Canagliflozin 300 mg-1.83

[back to top]

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18

The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. (NCT01381900)
Timeframe: Day 1 (Baseline) and Week 18

InterventionPercent (Least Squares Mean)
Placebo-0.47
Canagliflozin 100 mg-0.97
Canagliflozin 300 mg-1.06

[back to top]

Percent Change in Body Weight From Baseline to Week 18

The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. (NCT01381900)
Timeframe: Day 1 (Baseline) and Week 18

InterventionPecent change (Least Squares Mean)
Placebo-0.8
Canagliflozin 100 mg-2.9
Canagliflozin 300 mg-3.1

[back to top]

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18

The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01381900)
Timeframe: Day 1 (Baseline) and Week 18

InterventionPercentage of patients (Number)
Placebo27.8
Canagliflozin 100 mg49.1
Canagliflozin 300 mg52.9

[back to top]

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18

The table below shows the percentage of patients with HbA1c <6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. (NCT01381900)
Timeframe: Day 1 (Baseline) and Week 18

InterventionPercentage of patients (Number)
Placebo11.7
Canagliflozin 100 mg21.6
Canagliflozin 300 mg25.3

[back to top]

Change in Systolic Blood Pressure From Baseline at Week 26

The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups. (NCT01809327)
Timeframe: Day 1 (Baseline) and Week 26

Interventionmillimeter of mercury (mm Hg) (Least Squares Mean)
Metformin XR-0.33
Canagliflozin 100 Milligram (mg)-2.24
Canagliflozin 300 mg-2.36
Canagliflozin 100 mg + Metformin XR-2.24
Canagliflozin 300 mg + Metformin XR-1.65

[back to top]

Number of Participants With Treatment Emergent Adverse Events (AEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. (NCT01809327)
Timeframe: Up to 30 weeks of last study drug administration

Interventionparticipants (Number)
Metformin XR89
Canagliflozin 100 Milligram (mg)88
Canagliflozin 300 mg95
Canagliflozin 100 mg + Metformin XR99
Canagliflozin 300 mg + Metformin XR105

[back to top]

Percent Change in Body Weight From Baseline to Week 26

The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups. (NCT01809327)
Timeframe: Day 1 (Baseline) and Week 26

Interventionpercent change (Least Squares Mean)
Metformin XR-2.1
Canagliflozin 100 Milligram (mg)-3.0
Canagliflozin 300 mg-3.9
Canagliflozin 100 mg + Metformin XR-3.5
Canagliflozin 300 mg + Metformin XR-4.2

[back to top]

Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26

The percentage change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) from baseline to Week 26 was compared between the different treatment groups. (NCT01809327)
Timeframe: Day 1 (Baseline) and Week 26

Interventionpercent change (Least Squares Mean)
Metformin XR10.2
Canagliflozin 100 Milligram (mg)17.6
Canagliflozin 300 mg16.6
Canagliflozin 100 mg + Metformin XR15.5
Canagliflozin 300 mg + Metformin XR14.5

[back to top]

Percent Change in Triglycerides From Baseline to Week 26

The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups. (NCT01809327)
Timeframe: Day 1 (Baseline) and Week 26

Interventionpercent change (Mean)
Metformin XR13.6
Canagliflozin 100 Milligram (mg)1.7
Canagliflozin 300 mg2.8
Canagliflozin 100 mg + Metformin XR13.0
Canagliflozin 300 mg + Metformin XR21.2

[back to top]

Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26

The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups. (NCT01809327)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Metformin XR43.0
Canagliflozin 100 Milligram (mg)38.8
Canagliflozin 300 mg42.8
Canagliflozin 100 mg + Metformin XR49.6
Canagliflozin 300 mg + Metformin XR56.8

[back to top]

Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26

The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups. (NCT01809327)
Timeframe: Day 1 (Baseline) and Week 26

Interventionpercentage of hemoglobin (Least Squares Mean)
Metformin XR-1.30
Canagliflozin 100 Milligram (mg)-1.37
Canagliflozin 300 mg-1.42
Canagliflozin 100 mg + Metformin XR-1.77
Canagliflozin 300 mg + Metformin XR-1.78

[back to top]

Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6

The standing heart rate was evaluated. (NCT01939496)
Timeframe: Baseline, Day 2, Week 3 and 6

,,
Interventionbeats per minute (Mean)
Baseline (n=56,57,56)Change From Baseline at Day 2 (n=55,57,56)Change From Baseline at Week 3 (n=55,57,56)Change From Baseline at Week 6 (n=55,57,56)
Canagliflozin 100 Milligram (mg)78.654.323.471.44
Canagliflozin 300 mg81.862.790.48-0.68
Placebo82.540.27-0.89-0.07

[back to top]

Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6

The standing office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure. (NCT01939496)
Timeframe: Baseline, Day 2, Week 3 and 6

,,
Interventionmillimeter of mercury (mmHg) (Mean)
SBP: Baseline (n=56,57,56)SBP: Change From Baseline at Day 2 (n=55,57,56)SBP: Change From Baseline at Week 3 (n=55,57,56)SBP: Change From Baseline at Week 6 (n=55,57,56)DBP: Baseline (n=55,57,56)DBP: Change From Baseline at Day 2 (n=55,57,56)DBP: Change From Baseline at Week 3 (n=55,57,56)DBP: Change From Baseline at Week 6 (n=55,57,56)
Canagliflozin 100 Milligram (mg)139.3-2.46-7.12-7.9585.25-0.60-3.47-2.51
Canagliflozin 300 mg140.8-5.91-11.9-11.386.09-1.32-5.36-4.55
Placebo140.3-4.36-6.55-3.7685.79-0.65-2.91-0.89

[back to top]

Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6

The difference in seated heart rate and standing heart rate was evaluated. (NCT01939496)
Timeframe: Baseline, Day 2, Week 3 and 6

,,
Interventionbeats per minute (Mean)
Baseline (n=56,57,56)Change From Baseline at Day 2 (n=55,57,56)Change From Baseline at Week 3 (n=55,57,56)Change From Baseline at Week 6 (n=55,57,56)
Canagliflozin 100 Milligram (mg)3.601.261.770.37
Canagliflozin 300 mg3.731.111.380.48
Placebo2.961.671.352.16

[back to top]

Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6

The difference in seated office blood pressure and standing office blood pressure was evaluated. (NCT01939496)
Timeframe: Baseline, Day 2, Week 3 and 6

,,
Interventionmillimeter of mercury (mmHg) (Mean)
Baseline (n=56,57,56)Change From Baseline at Day 2 (n=55,57,56)Change From Baseline at Week 3 (n=55,57,56)Change From Baseline at Week 6 (n=55,57,56)
Canagliflozin 100 Milligram (mg)0.78-0.390.40-2.96
Canagliflozin 300 mg1.55-0.80-1.27-3.90
Placebo2.65-1.13-0.60-0.41

[back to top]

Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6

The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings. (NCT01939496)
Timeframe: Baseline, Day 2 and Week 6

,,
Interventionmillimeter of mercury (mmHg) (Mean)
Baseline (n=56,57,56)Change From Baseline at Day 2 (n=50,50,50)Change From Baseline at Week 6 (n=54,54,55)
Canagliflozin 100 Milligram (mg)78.01-0.85-2.18
Canagliflozin 300 mg79.31-0.45-3.27
Placebo78.361.01-0.26

[back to top]

Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6

The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings. (NCT01939496)
Timeframe: Baseline and Week 6

,,
Interventionmillimeter of mercury (mmHg) (Mean)
Baseline (n=56,57,56)Change From Baseline at Week 6 (n=54,54,55)
Canagliflozin 100 Milligram (mg)136.5-4.78
Canagliflozin 300 mg139.6-7.31
Placebo136.7-1.26

[back to top]

Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6

The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings. (NCT01939496)
Timeframe: Baseline, Day 2 and Week 6

,,
Interventionmillimeter of mercury (mmHg) (Mean)
Baseline (n=56,57,56)Change From Baseline at Day 2 (n=50,50,50)Change From Baseline at Week 6 (n=54,54,55)
Canagliflozin 100 Milligram (mg)128.3-1.02-4.33
Canagliflozin 300 mg130.2-4.37-6.98
Placebo129.3-0.19-3.49

[back to top]

Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6

The seated heart rate was evaluated. (NCT01939496)
Timeframe: Baseline, Day 2, Week 3 and 6

,,
Interventionbeats per minute (Mean)
Baseline (n=56,57,56)Change From Baseline at Day 2 (n=55,57,56)Change From Baseline at Week 3 (n=55,57,56)Change From Baseline at Week 6 (n=55,57,56)
Canagliflozin 100 Milligram (mg)75.053.051.701.07
Canagliflozin 300 mg78.131.68-0.89-1.16
Placebo79.57-1.40-2.24-2.24

[back to top]

Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6

The seated office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure. (NCT01939496)
Timeframe: Baseline, Day 2, Week 3 and 6

,,
Interventionmillimeter of mercury (mmHg) (Mean)
SBP: Baseline (n=56,57,56)SBP: Change From Baseline at Day 2 (n=55,57,56)SBP: Change From Baseline at Week 3 (n=55,57,56)SBP: Change From Baseline at Week 6 (n=55,57,56)DBP: Baseline (n=55,57,56)DBP: Change From Baseline at Day 2 (n=55,57,56)DBP: Change From Baseline at Week 3 (n=55,57,56)DBP: Change From Baseline at Week 6 (n=55,57,56)
Canagliflozin 100 Milligram (mg)138.5-2.06-7.53-4.9882.37-0.26-2.22-1.52
Canagliflozin 300 mg139.2-5.11-10.6-7.3883.02-0.87-4.23-2.43
Placebo137.7-3.24-5.95-3.3682.67-2.61-2.84-1.78

[back to top]

Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2

The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings. (NCT01939496)
Timeframe: Baseline and Day 2

,,
Interventionmillimeter of mercury (mmHg) (Mean)
Baseline (n=56,57,56)Change From Baseline at Day 2 (n=50,50,50)
Canagliflozin 100 Milligram (mg)136.5-1.78
Canagliflozin 300 mg139.6-1.97
Placebo136.70.49

[back to top]

Change From Baseline in Body Weight to Week 6

Body weight was evaluated. (NCT01939496)
Timeframe: Baseline and Week 6

,,
InterventionKilogram (kg) (Mean)
Baseline (n=56,57,56)Change From Baseline at Week 6 (n=54,55,56)
Canagliflozin 100 Milligram (mg)95.32-0.98
Canagliflozin 300 mg96.06-1.47
Placebo91.650.14

[back to top]

Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6

The fasting plasma glucose was evaluated. (NCT01939496)
Timeframe: Baseline and Week 6

,,
Interventionmillimoles per liter (mmol/L) (Mean)
Baseline (n=56,57,56)Change From Baseline at Week 6 (n=55,54,55)
Canagliflozin 100 Milligram (mg)9.69-0.03
Canagliflozin 300 mg9.38-1.27
Placebo9.84-0.38

[back to top]

Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6

The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings. (NCT01939496)
Timeframe: Baseline, Day 2 and Week 6

,,
Interventionmillimeter of mercury (mmHg) (Mean)
Baseline (n=56,57,56)Change From Baseline at Day 2 (n=50,50,50)Change From Baseline at Week 6 (n=54,54,55)
Canagliflozin 100 Milligram (mg)80.53-1.08-2.39
Canagliflozin 300 mg81.810.03-3.23
Placebo80.841.21-0.20

[back to top]

Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6

The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings. (NCT01939496)
Timeframe: Baseline, Day 2 and Week 6

,,
Interventionmillimeter of mercury (mmHg) (Mean)
Baseline (n=56,57,56)Change From Baseline at Day 2 (n=50,50,50)Change From Baseline at Week 6 (n=54,54,55)
Canagliflozin 100 Milligram (mg)139.6-2.06-5.05
Canagliflozin 300 mg142.8-1.16-7.36
Placebo139.40.96-0.65

[back to top]

Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6

The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings. (NCT01939496)
Timeframe: Baseline, Day 2 and Week 6

,,
Interventionmillimeter of mercury (mmHg) (Mean)
Baseline (n=56,57,56)Change From Baseline at Day 2 (n=50,50,50)Change From Baseline at Week 6 (n=54,54,55)
Canagliflozin 100 Milligram (mg)71.10-0.23-1.73
Canagliflozin 300 mg72.31-2.24-3.42
Placebo71.570.87-0.98

[back to top]

Progression of Albuminuria

Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio [UACR] 30 to 300 milligram per gram [mg/g]) or macroalbuminuria (Albumin/creatinine ratio [ACR] of greater than [>] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than [<] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (>=) 30 percent from baseline. Participants with macroalbuminuria at baseline (ACR>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event. (NCT01989754)
Timeframe: Up to 3 years

InterventionEvents per 1000 patient-year (Number)
Placebo153.01
Canagliflozin (Experimental)99.80

[back to top]

Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure

Analyses were using adjudicated events, that is (i.e.) CV death events or hospitalization due to heart failure, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event. (NCT01989754)
Timeframe: Approximately 3 years

InterventionEvents per 1000 patient-years (Number)
Placebo21.91
Canagliflozin (Experimental)15.85

[back to top]

Cardiovascular (CV) Death

Analyses were using adjudicated events, i.e. CV death events, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event. (NCT01989754)
Timeframe: Approximately 3 years

InterventionEvents per 1000 patient-years (Number)
Placebo11.60
Canagliflozin (Experimental)10.06

[back to top]

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

(NCT02025907)
Timeframe: Baseline and Week 26

Interventionpercentage of glycosylated hemoglobin (Least Squares Mean)
Placebo-0.01
Canagliflozin-0.91

[back to top]

Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26

(NCT02025907)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Placebo12.2
Canagliflozin32.3

[back to top]

Percent Change From Baseline in Body Weight at Week 26

(NCT02025907)
Timeframe: Baseline and Week 26

Interventionpercent change (Least Squares Mean)
Placebo-1.60
Canagliflozin-3.35

[back to top]

Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

(NCT02025907)
Timeframe: Baseline and Week 26

Interventionmillimeter of mercury (mmHg) (Least Squares Mean)
Placebo0.09
Canagliflozin-5.76

[back to top]

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

(NCT02025907)
Timeframe: Baseline and Week 26

Interventionmillimoles per liter (Least Squares Mean)
Placebo-0.14
Canagliflozin-1.65

[back to top]

Cardiovascular (CV) Death

CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of CV death are presented. (NCT02065791)
Timeframe: Up to 4.6 years

InterventionEvent rate per 1000 participant-years (Number)
Placebo24.38
Canagliflozin 100 mg19.01

[back to top]

Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)

The composite endpoint included CV death and HHF. CV death included death due to myocardial infarction (MI), stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the composite endpoint of CV death and HHF are presented. (NCT02065791)
Timeframe: Up to 4.6 years

InterventionEvent rate per 1000 participant-years (Number)
Placebo45.44
Canagliflozin 100 mg31.47

[back to top]

CV Composite Endpoint

The CV composite endpoint included the CV death, non-fatal MI, non-fatal stroke, hospitalized heart failure, and hospitalized unstable angina. CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the CV composite endpoint are presented. (NCT02065791)
Timeframe: Up to 4.6 years

InterventionEvent rate per 1000 participant-years (Number)
Placebo66.95
Canagliflozin 100 mg49.35

[back to top]

Hospitalized Heart Failure (HHF)

Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of hospitalized heart failure are presented. (NCT02065791)
Timeframe: Up to 4.6 years

InterventionEvent rate per 1000 participant-years (Number)
Placebo25.33
Canagliflozin 100 mg15.65

[back to top]

Major Adverse Cardiac Event (MACE)

The composite endpoint included CV death, non-fatal MI, and non-fatal stroke (that is, 3-point MACE). Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented. (NCT02065791)
Timeframe: Up to 4.6 years

InterventionEvent rate per 1000 participant-years (Number)
Placebo48.67
Canagliflozin 100 mg38.71

[back to top]

Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death

Primary composite endpoint is the composite of DoSC, ESKD, and renal or CV death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: as initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an estimated glomerular filtration rate (eGFR) value of less than (<)15 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who had reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in blinded fashion. Event rate estimated based on time to first occurrence of primary composite endpoint are presented. (NCT02065791)
Timeframe: Up to 4.6 years

InterventionEvent rate per 1000 participant-years (Number)
Placebo61.24
Canagliflozin 100 mg43.21

[back to top]

All-cause Mortality

Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on time to first occurrence of all-cause mortality are presented. (NCT02065791)
Timeframe: Up to 4.6 years

InterventionEvent rate per 1000 participant-years (Number)
Placebo35.00
Canagliflozin 100 mg29.04

[back to top]

Renal Composite Endpoint

The renal composite endpoint included composite of DoSC, ESKD and Renal death. DoSC: from the baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of <15 mL/min/1.73 m^2 (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who have reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented. (NCT02065791)
Timeframe: Up to 4.6 years

InterventionEvent rate per 1000 participant-years (Number)
Placebo40.36
Canagliflozin 100 mg26.99

[back to top]

Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight

Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight. (NCT02139943)
Timeframe: Week 18

,,
Interventionpercentage of participants (Number)
YesNo
Canagliflozin 100 Milligram (mg)36.963.1
Canagliflozin 300 mg41.458.6
Placebo14.585.5

[back to top]

Percentage of Participants With Adverse Events

(NCT02139943)
Timeframe: Up to 22 Weeks

Interventionpercentage of participants (Number)
Placebo54.7
Canagliflozin 100 Milligram (mg)55.6
Canagliflozin 300 mg67.5

[back to top]

Change From Baseline in Fasting Plasma Glucose Level

The change from baseline in fasting plasma glucose level collected at Week 52. (NCT02220907)
Timeframe: Baseline, 52 Weeks

Interventionmg/dL (Mean)
Teneligliptin+Canagliflozin-38.6

[back to top]

Percentage Change in Body Weight From Baseline

The percentage change from baseline in body weight collected at Week 52. (NCT02220907)
Timeframe: Baseline, 52 Weeks

Interventionpercent change (Mean)
Teneligliptin+Canagliflozin-3.92

[back to top]

Number of Participants With Adverse Events

(NCT02220907)
Timeframe: 52 Weeks

Interventionparticipants (Number)
Serious Adverse EventAdverse Event
Teneligliptin+Canagliflozin11107

[back to top]

Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)

The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52. (NCT02220907)
Timeframe: Baseline, 52 Weeks

Interventionpercentage of HbA1c (Mean)
Teneligliptin+Canagliflozin-0.99

[back to top]

"Percentage of Participants With Adverse Events and Hypoglycemia and Blood Glucose Decreased"

(NCT02220920)
Timeframe: Week 16

,
Interventionpercentage of participants (Number)
adverse eventsHypoglycemia and Blood glucose decreased
Canagliflozin (TA-7284) +Insulin68.040.0
Placebo+Insulin64.829.6

[back to top]

Change in Blood Pressure

(NCT02220920)
Timeframe: baseline and Week 16

,
InterventionmmHg (Least Squares Mean)
Systolic blood pressureDiastolic blood pressure
Canagliflozin (TA-7284) +Insulin-3.58-1.55
Placebo+Insulin-0.40-0.31

[back to top]

Change in Fasting Plasma Glucose

(NCT02220920)
Timeframe: baseline and Week 16

Interventionmg/dL (Least Squares Mean)
Canagliflozin (TA-7284) +Insulin-34.1
Placebo+Insulin-1.4

[back to top]

Change in HbA1c From Baseline

(NCT02220920)
Timeframe: baseline and Week 16

InterventionPercent (Least Squares Mean)
Canagliflozin (TA-7284) +Insulin-0.97
Placebo+Insulin0.13

[back to top]

Percent Change in Body Weight

(NCT02220920)
Timeframe: baseline and Week 16

Interventionpercent change (Least Squares Mean)
Canagliflozin (TA-7284) +Insulin-2.13
Placebo+Insulin0.24

[back to top]

Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)

(NCT02227849)
Timeframe: 52 Weeks

InterventionParticipants (Count of Participants)
Serious Adverse EventAdverse Event
Canagliflozin (TA-7284) + GLP-1 Analogue551

[back to top]

Change in Blood Pressure

(NCT02227849)
Timeframe: Baseline, 52 Weeks

InterventionmmHg (Mean)
Systolic blood pressureDiastolic blood pressure
Canagliflozin (TA-7284) + GLP-1 Analogue-7.90-4.32

[back to top]

Percentage Change in Body Weight

(NCT02227849)
Timeframe: Baseline, 52 Weeks

Interventionpercent change (Mean)
Canagliflozin (TA-7284) + GLP-1 Analogue-4.46

[back to top]

Change in Percentage of HbA1c

(NCT02227849)
Timeframe: Baseline, 52 Weeks

Interventionpercentage of HbA1c (Mean)
Canagliflozin (TA-7284) + GLP-1 Analogue-0.70

[back to top]

Change in Fasting Plasma Glucose

(NCT02227849)
Timeframe: Baseline, 52 Weeks

Interventionmg/dL (Mean)
Canagliflozin (TA-7284) + GLP-1 Analogue-34.7

[back to top]

Change From Baseline in Systolic Blood Pressure at Week 26

Change from baseline in systolic blood pressure was analysed at week 26. (NCT02243202)
Timeframe: Week 26

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
Placebo-2.7
Phentermine 15 mg-1.4
Canagliflozin 300 mg-3.1
Canagliflozin 300 mg/Phentermine 15 mg-6.9

[back to top]

Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26

Change from baseline in diastolic blood pressure (DBP) at week 26. (NCT02243202)
Timeframe: Week 26

InterventionmmHg (millimeters of mercury) (Least Squares Mean)
Placebo-0.9
Phentermine 15 mg0.1
Canagliflozin 300 mg-1.5
Canagliflozin 300 mg/Phentermine 15 mg-2.5

[back to top]

Absolute Change From Baseline in Body Weight at Week 26

Absolute change from baseline in body weight was analysed at week 26. (NCT02243202)
Timeframe: Week 26

InterventionKilogram (Kg) (Least Squares Mean)
Placebo-0.6
Phentermine 15 mg-4.1
Canagliflozin 300 mg-1.9
Canagliflozin 300 mg/Phentermine 15 mg-7.3

[back to top]

Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26

Percentage of participants with weight loss >= 5 percent were analysed at week 26. (NCT02243202)
Timeframe: Week 26

Interventionpercentage of participants (Number)
Placebo17.5
Phentermine 15 mg41.7
Canagliflozin 300 mg17.9
Canagliflozin 300 mg/Phentermine 15 mg66.7

[back to top]

Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26

Percentage of participants with weight loss >= 10 percent at week 26. (NCT02243202)
Timeframe: Week 26

InterventionPercentage of Participants (Number)
Placebo8.8
Phentermine 15 mg8.3
Canagliflozin 300 mg5.4
Canagliflozin 300 mg/Phentermine 15 mg34.9

[back to top]

Change From Baseline in Pulse Rate at Week 26

Change from baseline in pulse rate at week 26 (NCT02243202)
Timeframe: Week 26

InterventionBeats Per Minute (Beats/Min) (Least Squares Mean)
Placebo-0.7
Phentermine 15 mg4.1
Canagliflozin 300 mg0.7
Canagliflozin 300 mg/Phentermine 15 mg3.5

[back to top]

Percent Change From Baseline in Body Weight at Week 26

The percent change from baseline in body weight at Week 26 was analysed. (NCT02243202)
Timeframe: Week 26

InterventionPercent Change (Least Squares Mean)
Placebo-0.6
Phentermine 15 mg-4.1
Canagliflozin 300 mg-1.9
Canagliflozin 300 mg/Phentermine 15 mg-7.5

[back to top]

Change in 24-hour Blood Pressure at Study End Compared to Baseline.

Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA. (NCT02324842)
Timeframe: Approximately 4 months

InterventionmmHg (Mean)
Canagliflozin-5.2
Liraglutide5.1
Canagliflozin Plus Liraglutide-14.1

[back to top]

HbA1c at 4 Months

Primary end point of the study is the HbA1c level in response to canagliflozin alone, liraglutide or canagliflozin with liraglutide. (NCT02324842)
Timeframe: Approximately 4 months

Interventionpercentage glycated hemoglobin (Mean)
Canagliflozin8.2
Liraglutide8.4
Canagliflozin Plus Liraglutide8.1

[back to top]

Fasting Plasma Glucose (FPG) at 4 Months

Values will be presented as the mean + (Standard Deviation) SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA. (NCT02324842)
Timeframe: Baseline to Approximately 4 months

Interventionmg/dl (Mean)
Canagliflozin174
Liraglutide177
Canagliflozin Plus Liraglutide180

[back to top]

Change in Total Body Weight at Study End Compared to Baseline

Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA. The difference between baseline and study end will represent the change in body weight due to change in hepatic, visceral and abdominal subcutaneous fat. (NCT02324842)
Timeframe: Approximately 4 months

Interventionkg (Mean)
Canagliflozin-3.5
Liraglutide-1.9
Canagliflozin Plus Liraglutide-6.0

[back to top]

Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline

Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA. (NCT02324842)
Timeframe: Approximately 4 months

Interventionmg/ml (Mean)
Canagliflozin12
Liraglutide-7
Canagliflozin Plus Liraglutide-5

[back to top]

Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)

Values will be presented as the mean + SD. The Matsuda Index is a novel assessment of insulin sensitivity that is simple to calculate and provides a reasonable approximation of whole-body insulin sensitivity from the OGTT. The index is calculated from plasma glucose (mg/dl) and insulin (mIU/l) concentrations in both fasting state and post-OGTT. The index value obtained is compared to normal physiologic values to assess insulin sensitivity or resistance. The higher the number, the more insulin sensitive and the lower the number the more insulin resistant the subjects are. Insulin secretion will be measured from plasma C-peptide concentration during the OGTT and the Mari Model will be used to measure beta cell glucose sensitivity (NCT02324842)
Timeframe: Change from Baseline to Approximately 4 months

Interventionindex value (Mean)
Canagliflozin0.8
Liraglutide-0.5
Canagliflozin Plus Liraglutide0.1

[back to top]

Change in Free Plasma Insulin at the End of the Study From Baseline Value

Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA. (NCT02324842)
Timeframe: At Approximately 4 months

Interventionmg/ml (Mean)
Canagliflozin-2
Liraglutide2
Canagliflozin Plus Liraglutide0.7

[back to top]

Body Mass Index (BMI) at 4 Months

A measure of BMI at 4 months to examine effects of combination therapy with liraglutide plus canagliflozin. (NCT02324842)
Timeframe: Approximately 4 months

Interventionkg/m2 (Mean)
Canagliflozin34.8
Liraglutide35.1
Canagliflozin Plus Liraglutide34.8

[back to top]

Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)

The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24. (NCT02354222)
Timeframe: Baseline, 24 Weeks

Interventionpercentage of HbA1c (Least Squares Mean)
Teneligliptin+Canagliflozin-0.94
Placebo+Canagliflozin0.00

[back to top]

Percentage Change in Body Weight From Baseline

The percentage change from baseline in body weight collected at Week 24. (NCT02354222)
Timeframe: Baseline, 24 Weeks

Interventionpercent change (Least Squares Mean)
Teneligliptin+Canagliflozin0.09
Placebo+Canagliflozin-1.34

[back to top]

Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)

The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24. (NCT02354222)
Timeframe: 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks

Interventionhour*mg/dL (Least Squares Mean)
Teneligliptin+Canagliflozin-50.2
Placebo+Canagliflozin5.7

[back to top]

Change From Baseline in Fasting Plasma Glucose Level

The change from baseline in fasting plasma glucose level collected at Week 24. (NCT02354222)
Timeframe: Baseline, 24 Weeks

Interventionmg/dL (Least Squares Mean)
Teneligliptin+Canagliflozin-5.6
Placebo+Canagliflozin10.0

[back to top]

Change From Baseline in 2-hour Postprandial Plasma Glucose Level

The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24. (NCT02354222)
Timeframe: 2 Hours Postprandial, at Baseline and 24 Weeks

Interventionmg/dL (Least Squares Mean)
Teneligliptin+Canagliflozin-35.3
Placebo+Canagliflozin2.3

[back to top]

Percentage Change in Body Weight From Baseline

The percentage change from baseline in body weight collected at Week 24. (NCT02354235)
Timeframe: Baseline, 24 Weeks

Interventionpercent change (Least Squares Mean)
Canagliflozin+Teneligliptin-3.32
Placebo+Teneligliptin-0.99

[back to top]

Change From Baseline in 2-hour Postprandial Plasma Glucose Level

The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24. (NCT02354235)
Timeframe: 2 Hours Postprandial, at Baseline and 24 Weeks

Interventionmg/dL (Least Squares Mean)
Canagliflozin+Teneligliptin-60.1
Placebo+Teneligliptin-9.2

[back to top]

Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)

The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24. (NCT02354235)
Timeframe: 0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks

Interventionhour*mg/dL (Least Squares Mean)
Canagliflozin+Teneligliptin-105.9
Placebo+Teneligliptin-5.6

[back to top]

Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)

The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24. (NCT02354235)
Timeframe: Baseline, 24 Weeks

Interventionpercentage of HbA1c (Least Squares Mean)
Canagliflozin+Teneligliptin-0.97
Placebo+Teneligliptin-0.10

[back to top]

Change From Baseline in Fasting Plasma Glucose Level

The change from baseline in fasting plasma glucose level collected at Week 24. (NCT02354235)
Timeframe: Baseline, 24 Weeks

Interventionmg/dL (Least Squares Mean)
Canagliflozin+Teneligliptin-34.9
Placebo+Teneligliptin3.9

[back to top]

Change in Body Composition, Measured Using DXA Scanning.

Body composition will be measured at baseline and at study completion using DXA scanning. (NCT02360774)
Timeframe: 18 weeks (duration of study)

Intervention% fat (Mean)
Canagliflozin-0.2
Placebo-0.4

[back to top]

Change in Body Weight

Body weight will be measured at each study visit (screening visit, enrollment (study week 0), and at study weeks 2, 4, 8, 12 and 18). Change in body weight will be calculated using ANOVA such that body weight at all time points is included in the data analysis, rather than simply comparing weight at the enrollment visit to weight at the final study visit. (NCT02360774)
Timeframe: 18 weeks (duration of study)

Interventionkg (Mean)
Canagliflozin3.0
Placebo0.3

[back to top]

Change in Glycemic Control

Hemoglobin A1C will be measured at baseline and at study completion. (NCT02360774)
Timeframe: 18 weeks (duration of study)

Interventionpercent glycated hemoglobin (Mean)
Canagliflozin-0.4
Placebo-0.1

[back to top]

Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery

Resting energy expenditure will be measured at each study visit using indirect calorimetery. Data analysis will include change in REE from baseline to study conclusion, as well as change in REE throughout the study. (NCT02360774)
Timeframe: 18 weeks (duration of study)

Interventionkcal (Mean)
Canagliflozin-60.8
Placebo-68.6

[back to top]

Canagliflozin-induced Change in Urinary Excretion of Sodium

The pharmacodynamic response to canagliflozin will be assessed by measuring the % increase in 24 hour urinary excretion of sodium. (NCT02462421)
Timeframe: 24 hours after administration of canagliflozin

Intervention% increase in urinary Na excretion (Mean)
Wild Type Genotype20
Nonsense Mutation in SLC5A466
Nonsense Mutation in SLC5A918
Missense Variant in SLC2A948
Total Population32

[back to top]

Change in Fractional Excretion of Uric Acid (the Difference Between Data After Administration of Canagliflozin Minus Data Before Administration of Canagliflozin)

For the study arm focused on individuals with a genetic variant in SLC2A9, the pharmacodynamic response to canagliflozin will be assessed by measuring the absolute change in fractional excretion of uric acid in the urine. Fractional excretion of uric acid represents the fraction of the calculated filtered uric acid load (serum uric acid level multiplied by the measured creatinine clearance rate) that was excreted in the urine. (NCT02462421)
Timeframe: 24 hour urine collection after administration of canagliflozin

Interventionabsolute change in fractional excretion (Mean)
Wild Type Genotype0.25
Nonsense Mutation in SLC5A40.25
Nonsense Mutation in SLC5A90.28
Missense Variant in SLC2A90.38
Total Population0.29

[back to top]

Urinary Excretion of Glucose (Measured During the 24 Hours Following Administration of Canagliflozin)

The pharmacodynamic response to canagliflozin will be assessed by measuring the increase in 24 hour urinary glucose excretion. (NCT02462421)
Timeframe: 24 hours after administration of canagliflozin

Interventionglucose (g)/creatinine (g) (Mean)
Wild Type Genotype37.6
Nonsense Mutation in SLC5A437.1
Nonsense Mutation in SLC5A939.1
Missense Variant in SLC2A936.9
Total Population37.7

[back to top]

Canagliflozin-induced Change in Serum Creatinine

The pharmacodynamic response to canagliflozin will be assessed by measuring changes in serum creatinine (NCT02462421)
Timeframe: 24 hours after administration of canagliflozin

Interventionmg/dL (Mean)
Wild Type Genotype0.06
Nonsense Mutation in SLC5A4-0.03
Nonsense Mutation in SLC5A90.07
Missense Variant in SLC2A90.05
Total Population0.04

[back to top]

Canagliflozin-induced Change in Fasting Plasma Glucose

The magnitude of the change in fasting plasma glucose 24 hours after administration of canagliflozin (300 mg) (NCT02462421)
Timeframe: 24 hrs

Interventionmg/dL (Mean)
Wild Type Genotype-5.0
Nonsense Mutation in SLC5A4-2.0
Nonsense Mutation in SLC5A9-4.7
Missense Variant in SLC2A9-3.4
Total Study Population-4.2

[back to top]

Canagliflozin-induced Change in Serum Uric Acid

The pharmacodynamic response to canagliflozin will be assessed by measuring changes in serum uric acid level (NCT02462421)
Timeframe: 24 hours after administration of canagliflozin

Intervention% change in serum uric acid level (Mean)
Wild Type Genotype-22
Nonsense Mutation in SLC5A4-29
Nonsense Mutation in SLC5A9-12
Missense Variant in SLC2A9-17
Total Study Population-20

[back to top]

Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks

The self-monitored plasma glucose (SMPG) data were collected at the following 6 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin use, SGLT2 inhibitor use, country, visit, baseline HbA1c strata, and treatment-by-visit interaction as fixed effects and baseline as a covariate. (NCT02597049)
Timeframe: Baseline, Week 24

,,
Interventionmg/dL (Least Squares Mean)
Pre-morning Morning Meal2-Hour Postprandial Morning MealPre-Mid Day Meal2-Hour Postprandial Mid Day MealPre-Evening Meal2-Hour Postprandial Evening Meal
0.75 mg Dulaglutide-23.2-41.1-22.0-25.5-30.1-30.6
1.5 mg Dulaglutide-27.8-44.6-26.0-31.8-30.3-36.0
Placebo-8.1-20.1-7.7-12.8-7.5-13.9

[back to top]

Change From Baseline in Body Weight at 24 Weeks

LS mean of the body weight change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, treatment-by-visit interactions as fixed effects, and baseline body weight as a covariate and participant as a random effect, via a MMRM analysis (NCT02597049)
Timeframe: Baseline, Week 24

,,
Interventionkilograms (kg) (Least Squares Mean)
Treatment-regimen EstimandEfficacy Estimand
0.75 mg Dulaglutide-2.6-2.6
1.5 mg Dulaglutide-3.1-3.1
Placebo-2.1-2.3

[back to top]

Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks

LS mean of change from baseline was calculated using last observation carried forward (LOCF) by treatment group, adjusted for treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, and baseline fasting serum glucose using analysis of covariance (ANCOVA). (NCT02597049)
Timeframe: Baseline, Week 24

,,
Interventionmilligram/deciliter (mg/dL) (Least Squares Mean)
Treatment-regimen EstimandEfficacy Estimand
0.75 mg Dulaglutide-26.5-26.0
1.5 mg Dulaglutide-31.6-31.9
Placebo-6.9-5.3

[back to top]

Number of Participants With Adjudicated Cardiovascular (CV) Events

Death and selected nonfatal CV adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the Sponsor. Nonfatal CV events that were to be adjudicated were myocardial infarction (MI); hospitalization for unstable angina; hospitalization for heart failure; coronary interventions such as coronary artery bypass graft (CABG) or ( percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack (TIA). (NCT02597049)
Timeframe: Baseline through 24 Weeks

,,
InterventionParticipants (Count of Participants)
Any CV EventFatal CV EventNon-fatal CV Event
0.75 mg Dulaglutide000
1.5 mg Dulaglutide000
Placebo303

[back to top]

Percentage of Participants With HbA1c <7%

Number of participants with an HbA1c value of <7% at Week 24 is measured using longitudinal logistic regression with repeated measurements. The model will include independent variables of treatment, country, SGLT2 inhibitor dose, metformin use, visit, treatment-by-visit interaction, and baseline HbA1c as a covariate. (NCT02597049)
Timeframe: 24 Weeks

,,
Interventionpercentage of participants (Number)
Treatment-regimen EstimandEfficacy Estimand
0.75 mg Dulaglutide60.4561.83
1.5 mg Dulaglutide71.2171.54
Placebo31.5832.52

[back to top]

Rate of Hypoglycemic Events Adjusted Per 30 Days

A hypoglycemic event is defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a PG level of ≤70 mg/dL (≤3.9 mmol/L). (NCT02597049)
Timeframe: Baseline through 24 Weeks

,,
InterventionNumber of events/participant/30 days (Mean)
Total HypoglycemiaDocumented Symptomatic HypoglycemiaAsymptomatic HypoglycemiaProbable SymptomaticRelative HypoglycemiaNocturnal Hypoglycemia
0.75 mg Dulaglutide0.0220.0130.0080.0010.0010.009
1.5 mg Dulaglutide0.0260.0130.0130.0000.0030.002
Placebo0.0170.0100.0060.0010.0050.000

[back to top]

Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)

LS mean of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The efficacy estimand excluded post-rescue data and compared the benefit of randomized treatments when taken as directed without rescue medication. (NCT02597049)
Timeframe: Baseline, Week 24

Interventionpercentage of HbA1c (Least Squares Mean)
1.5 mg Dulaglutide-1.33
0.75 mg Dulaglutide-1.19
Placebo-0.51

[back to top]

Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)

Least Squares mean (LS) of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The treatment-regimen estimand used all data including post-rescue data and compared the benefit of treatment regimens as they were actually taken. (NCT02597049)
Timeframe: Baseline, Week 24

Interventionpercentage of HbA1c (Least Squares Mean)
1.5 mg Dulaglutide-1.34
0.75 mg Dulaglutide-1.21
Placebo-0.54

[back to top]

Change From Baseline in Fasting Glucagon at 24 Weeks

Change from baseline in fasting glucagon was analyzed using an ANCOVA model with last observation carried forward (LOCF) included in treatment, country, SGLT2i dose, metformin use, and baseline HbA1c strata as fixed effects and baseline fasting glucagon as a covariate (with and without post rescue data). (NCT02597049)
Timeframe: Baseline, Week 24

,,
Interventionpicomole per liter (pmol/L) (Least Squares Mean)
Treatment-regimen EstimandEfficacy Estimand
0.75 mg Dulaglutide-1.5-1.4
1.5 mg Dulaglutide-2.1-2.2
Placebo-0.9-0.9

[back to top]

Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia

Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. (NCT02597049)
Timeframe: Baseline through 24 Weeks

InterventionParticipants (Count of Participants)
1.5 mg Dulaglutide0
0.75 mg Dulaglutide3
Placebo2

[back to top]

Number of Participants With Adjudicated Acute Pancreatitis Events

"The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 24 weeks. Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor.~A summary of serious and other non-serious events regardless of causality is located in the Reported Adverse Events module." (NCT02597049)
Timeframe: Baseline through 24 Weeks

InterventionParticipants (Count of Participants)
1.5 mg Dulaglutide0
0.75 mg Dulaglutide0
Placebo0

[back to top]

Percentage Change in Body Weight

(NCT02622113)
Timeframe: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

Interventionpercent change (Mean)
Placebo/CANA + Insulin-1.40
CANA/CANA + Insulin-2.14

[back to top]

Change in Percentage of HbA1c

(NCT02622113)
Timeframe: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

Interventionpercentage of HbA1c (Mean)
Placebo/CANA + Insulin-1.09
CANA/CANA + Insulin-0.88

[back to top]

Change in Fasting Plasma Glucose

(NCT02622113)
Timeframe: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

Interventionmg/dL (Mean)
Placebo/CANA + Insulin-33.1
CANA/CANA + Insulin-32.8

[back to top]

Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)

(NCT02622113)
Timeframe: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks

,
InterventionParticipants (Count of Participants)
Serious Adverse EventAdverse Event
CANA/CANA + Insulin769
Placebo/CANA + Insulin757

[back to top]

Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion

(NCT02673138)
Timeframe: 20 hours

Interventionmmol/L (Mean)
Basal Interruption0.8
Basal Interruption With Canagliflozin0.7

[back to top]

Differences in Plasma Glucose Levels Following the Interruption of Basal Subcutaneous Infusion of Insulin

The primary outcome measure for this study will be differences in plasma glucose levels following the interruption of basal subcutaneous infusion of insulin under the two study conditions; i.e., control study during treatment with insulin alone vs. experimental study during treatment with insulin plus canagliflozin or other SGLT2 inhibitor. (NCT02673138)
Timeframe: 20 hours

Interventionmg/dL (Mean)
Basal Interruption197
Basal Interruption With Canagliflozin99

[back to top]

Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal

(NCT02673138)
Timeframe: 20 hours

Interventionmmol/L (Mean)
Basal Interruption1.2
Basal Interruption With Canagliflozin1.5

[back to top]

Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion

(NCT02673138)
Timeframe: 20 hours

Interventionpg/mL (Mean)
Basal Interruption14
Basal Interruption With Canagliflozin36

[back to top]

Change at Six Months Versus Baseline in Hemoglobin A1c Value (%)

The change in hemoglobin A1c from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery (NCT02912455)
Timeframe: 6 months

Interventionpercentage (Mean)
Study Drug (Canagliflozin)-0.31
Placebo0.11

[back to top]

Change in Adiponectin Levels at 6 Months Compared to Randomization

The change in adiponectin levels from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery. (NCT02912455)
Timeframe: 6 months

Interventionug/mL (Mean)
Study Drug (Canagliflozin)0.7
Placebo-3.4

[back to top]

Change in Body Weight at Six Months Compared to Baseline

The change in body weight from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery. (NCT02912455)
Timeframe: 6 months

Interventionkilograms (Mean)
Study Drug (Canagliflozin)-3.77
Placebo6.33

[back to top]

Change in CRP Levels at 6 Months Compared to Baseline

The change in C-reactive protein levels from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery. (NCT02912455)
Timeframe: 6 months

Interventionmg/L (Mean)
Study Drug (Canagliflozin)-5.35
Placebo3.34

[back to top]

Change in Diastolic Blood Pressure at Six Months Compared to Baseline

The change in diastolic blood pressure from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery (NCT02912455)
Timeframe: 6 months

InterventionmmHg (Mean)
Study Drug (Canagliflozin)-1.18
Placebo2.95

[back to top]

Change in Fasting Glucose From Randomization

The change in fasting glucose from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery. (NCT02912455)
Timeframe: 6 months

Interventionmg/dL (Mean)
Study Drug (Canagliflozin)-32.90
Placebo-44.61

[back to top]

Change in Percentage of Truncal Fat

Change in percentage of truncal fat as measured by DEXA scan at 6 months compared to randomization (NCT02912455)
Timeframe: 6 months

Interventionpercent change (Mean)
Study Drug (Canagliflozin)-2.67
Placebo2.74

[back to top]

Change in Spine Bone Mineral Density

Change in spine bone marrow density as measured by DEXA scan at 6 months compared to randomization (NCT02912455)
Timeframe: 6 months

Interventiongrams per square centimeter (Mean)
Study Drug (Canagliflozin)-0.02
Placebo0.14

[back to top]

Change in Percentage of Lean Mass

Change in percentage of lean body mass as measured by DEXA scan at 6 months compared to randomization (NCT02912455)
Timeframe: 6 months

Interventionpercent change (Mean)
Study Drug (Canagliflozin)1.82
Placebo-2.65

[back to top]

Change in Percentage of Gynoid Fat

Change in percentage of gynoid fat as measured by DEXA scan at 6 months compared to randomization (NCT02912455)
Timeframe: 6 months

Interventionpercent change (Mean)
Study Drug (Canagliflozin)-1.69
Placebo2.17

[back to top]

Change in Percentage of Android Fat

Change in percentage of android fat as measured by DEXA scan at 6 months compared to randomization (NCT02912455)
Timeframe: 6 months

Interventionpercent change (Mean)
Study Drug (Canagliflozin)-3.00
Placebo3.33

[back to top]

Change in Percent Body Fat as Measured by DEXA Scan at 6 Months Compared to Randomization

The change in body fat from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery. (NCT02912455)
Timeframe: 6 months

Interventionpercent change (Mean)
Study Drug (Canagliflozin)-1.82
Placebo2.65

[back to top]

Change in Leptin Levels at 6 Months Compared to Baseline

Change in leptin levels at 6 months compared to baseline The change in leptin levels from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery. (NCT02912455)
Timeframe: 6 months

Interventionng/mL (Mean)
Study Drug (Canagliflozin)-8.1
Placebo-11

[back to top]

Number of Participants Who Reported Hypoglycemia From Each Group (at a Frequency of 1 Episode)

The number of participants who reported symptomatic hypoglycemia episodes from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery. (NCT02912455)
Timeframe: 6 months

Interventionparticipants (Number)
Study Drug (Canagliflozin)2
Placebo0

[back to top]

Change in Leg Bone Mineral Density

Change in leg bone marrow density as measured by DEXA scan at 6 months compared to randomization (NCT02912455)
Timeframe: 6 months

Interventiongrams per square centimeter (Mean)
Study Drug (Canagliflozin)0.01
Placebo-0.04

[back to top]

Change in Total Cholesterol

The change in total cholesterol from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery (NCT02912455)
Timeframe: 6 months

Interventionmg/dL (Mean)
Study Drug (Canagliflozin)-0.87
Placebo3.69

[back to top]

Change in Systolic Blood Pressure at 6 Months Compared to Baseline

The Change in Systolic Blood Pressure From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery (NCT02912455)
Timeframe: 6 months

InterventionmmHg (Mean)
Study Drug (Canagliflozin)4.62
Placebo12.63

[back to top]

Change From Baseline Ventilatory Efficiency at 12 Weeks

Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test (NCT02920918)
Timeframe: baseline and 12 weeks

InterventionUnitless (Mean)
Canagliflozin-0.3
Sitagliptin-0.3

[back to top]

Change From Baseline Aerobic Exercise Capacity at 12 Weeks

Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test (NCT02920918)
Timeframe: baseline and 12 weeks

InterventionmL/kg/min (Mean)
Canagliflozin0.67
Sitagliptin-0.53

[back to top]

Glycemic Control

Measured from blood glucose values (fasting) during visit (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported

Interventionmg/dL (Mean)
Active Arm142.79
Placebo Arm158.0

[back to top]

Glycemic Control (HbA1C)

As determined by HbA1C values (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported

Interventionpercentage of hemoglobin (Mean)
Active Arm7.85
Placebo Arm8.26

[back to top]

Microalbumin

Creatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported

Interventionmg/g creatinine (Mean)
Active Arm33.97
Placebo Arm43.41

[back to top]

Pulse Wave Velocity

Vessel health assessed by using arterial tonometry with the SphygmoCor CP system from ATCOR . (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported (also measured at 8 weeks)

Interventionm/s (Mean)
Active Arm10.12
Placebo Arm11.42

[back to top]

Resting Metabolic Rate (RMR)

Using ReeVue (trademark) machine, with or without SGLT2 inhibitor therapy to ascertain if Cana has any effect on RMR. Other related trials have shown weight loss but effect on metabolic rate has not been studied . (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment

Interventionkcal/day (Mean)
Active Arm1999.31
Placebo Arm1863.01

[back to top]

Serum Endothelial Inflammatory Markers (2)

Highly selective C-reactive protein (hs-CRP) (NCT02964585)
Timeframe: measured at 8 and 16 (reported) weeks post treatment

Interventionmg/L (Mean)
Active Arm0.63
Placebo Arm0.92

[back to top]

Augmentation Index (Pulse Wave Analysis)

Vessel health assessed by using arterial tonometry with the SphygmoCor CP system from ATCOR. Higher values generally correlate with increased cardiovascular risk. (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported (also measured at 8 weeks)

Interventionpercent aug pressure of pulse pressure (Mean)
Active Arm28.67
Placebo Arm21.37

[back to top]

Body Fat Percentage

Measured using a Tanita body composition scale (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment

Interventionpercentage of body mass (Mean)
Active Arm32.46
Placebo Arm38.58

[back to top]

eGFR

Creatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported

InterventionmL/min (Mean)
Active Arm79.90
Placebo Arm88.33

[back to top]

Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Proliferation)

To determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before [13,14]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis. (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported

InterventionColony forming units (CFU) (Mean)
Active Arm7.53
Placebo Arm13.69

[back to top]

Fasting Lipid Profile

Measured from a serum blood Lipid Panel: cholesterol and serum ketone bodies (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported (also measured at 8 weeks)

,
Interventionmg/dL (Mean)
CholesterolHDLLDL3-hydroxybutyric acid (ketone body)Acetoacetic acid (ketone body)
Active Arm171.5746.1796.030.020.69
Placebo Arm147.7651.6782.6720.030.30

[back to top]

Creatinine (Urine)

Creatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported

Interventionmmol/L (Mean)
Active Arm77.08
Placebo Arm106.23

[back to top]

BMI

Determined as weight in kg divided by height in meters squared (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment

Interventionkg/m^2 (Mean)
Active Arm30.53
Placebo Arm34.64

[back to top]

Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Counts)

To determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before [13,14]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis. (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported

,
Interventioncells*10^6/mL (Mean)
Mean MNC countMean CD34+ve cell count (x100)
Active Arm155.092682.93
Placebo Arm155.093157.36

[back to top]

Serum Endothelial Inflammatory Markers (1)

IL-6, and TNF-alpha (NCT02964585)
Timeframe: measured at 8 and 16 (reported) weeks post treatment

,
Interventionpg/mL (Mean)
IL-6TNF-alpha
Active Arm4.561.36
Placebo Arm3.211.63

[back to top]

Kidney Function Markers

Creatinine Clearance and Kidney Function measured from compiled results from a urine sample and blood tests (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported

,
Interventionug/dL (Mean)
PODXLNephrinWilm's Tumor
Active Arm6.625.245.75
Placebo Arm6.685.876.36

[back to top]

Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression)

To determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before [13,14]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis. (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported

,
Interventionng/mL in serum (Mean)
CXCL12 ExpressionCXCR4 ExpressionEDN1VEGEF-APECAMKDRNOS3CatalaseGPX35SDF 10 NGSOD2
Active Arm0.631.582.101.121.281.160.340.202.250.261.36
Placebo Arm0.330.901.030.830.890.5-0.25-0.611.710.230.92

[back to top]

Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Percentages)

To determine whether 4 months of Canagliflozin modifies CD34+ cell number, gene expression and migration function. The investigators will obtain a total of approximately 95 mL of peripheral blood per visit. Of these 95 mL, 60-70 mL will be used to obtain CD34+ cells from mononuclear cell (MNC) population and 25-35 mL for biochemistry and plasma ELISA assays. MNC will be obtained from whole blood similar to protocols described before [13,14]. MNCs will be put through CD34 magnetic bead column to obtain CD34+ cells (Miltenyi Biotec). Purity of CD34+ cells, post sort, usually is above 90%, to be verified by FACS analysis. (NCT02964585)
Timeframe: 16 weeks post Canagliflozin treatment reported

,
Interventionpercentage of MNCs (Mean)
Percent of CD34+Percent of CD31+Percent CD34+ and CD184+
Active Arm0.932.580.37
Placebo Arm1.232.160.61

[back to top]

Change in Total Fat Mass (kg)

Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

Interventionkg (Mean)
Semaglutide + Canagliflozin Placebo-3.72
Canagliflozin + Semaglutide Placebo-2.63

[back to top]

Change in SMPG- Mean Postprandial Increment Over All Meals

Change from baseline (week 0) to week 52 in SMPG- mean postprandial increment over all meals was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

Interventionmmol/L (Mean)
Semaglutide + Canagliflozin Placebo-0.6
Canagliflozin + Semaglutide Placebo-0.6

[back to top]

Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile

Change from baseline (week 0) to week 52 in SMPG- mean 7-point profile was evaluated. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

Interventionmmol/L (Mean)
Semaglutide + Canagliflozin Placebo-2.8
Canagliflozin + Semaglutide Placebo-1.9

[back to top]

Change in SF-36: Physical Component Summary (PCS)

Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain PCS. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period. (NCT03136484)
Timeframe: Week 0, week 52

InterventionScore on a scale (Mean)
Semaglutide + Canagliflozin Placebo2.7
Canagliflozin + Semaglutide Placebo2.9

[back to top]

Change in SF-36: Mental Component Summary (MCS)

Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain MCS. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period. (NCT03136484)
Timeframe: Week 0, week 52

InterventionScore on a scale (Mean)
Semaglutide + Canagliflozin Placebo1.1
Canagliflozin + Semaglutide Placebo0.5

[back to top]

Change in Ratio Between Total Fat Mass and Total Lean Mass

Change from baseline (week 0) to week 52 in ratio between total fat mass and total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

Interventiontotal fat mass/total lean mass ratio (Mean)
Semaglutide + Canagliflozin Placebo-0.04
Canagliflozin + Semaglutide Placebo-0.03

[back to top]

Change in Pulse

Change from baseline (week 0) to week 52 in pulse is presented based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionBeats per minute (beats/min) (Mean)
Semaglutide + Canagliflozin Placebo2.7
Canagliflozin + Semaglutide Placebo-0.6

[back to top]

Participants Who Achieved Weight Loss ≥5% (Yes/no)

Percentage of participants losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionPercentage of participants (Number)
YesNo
Canagliflozin + Semaglutide Placebo47.053.0
Semaglutide + Canagliflozin Placebo52.747.3

[back to top]

Participants Who Achieved Weight Loss ≥3% (Yes/no)

Percentage of participants losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionPercentage of participants (Number)
YesNo
Canagliflozin + Semaglutide Placebo64.935.1
Semaglutide + Canagliflozin Placebo68.831.2

[back to top]

Participants Who Achieved Weight Loss ≥10% (Yes/no)

Percentage of participants losing ≥10% of baseline body weight is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionPercentage of participants (Number)
YesNo
Canagliflozin + Semaglutide Placebo8.991.1
Semaglutide + Canagliflozin Placebo23.276.8

[back to top]

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no)

Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionPercentage of participants (Number)
YesNo
Canagliflozin + Semaglutide Placebo25.974.1
Semaglutide + Canagliflozin Placebo45.154.9

[back to top]

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no)

Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionPercentage of participants (Number)
YesNo
Canagliflozin + Semaglutide Placebo34.865.2
Semaglutide + Canagliflozin Placebo57.342.7

[back to top]

Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no)

Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥10% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionPercentage of participants (Number)
YesNo
Canagliflozin + Semaglutide Placebo6.193.9
Semaglutide + Canagliflozin Placebo21.878.2

[back to top]

Participants Who Achieved HbA1c Reduction ≥1% (Yes/no)

Percentage of participants who achieved ≥1% reduction of baseline HbA1c (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionPercentage of participants (Number)
YesNo
Canagliflozin + Semaglutide Placebo48.651.4
Semaglutide + Canagliflozin Placebo76.523.5

[back to top]

Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no)

Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter [mg/dL]) with symptoms consistent with hypoglycaemia. Percentage of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionPercentage of participants (Number)
YesNo
Canagliflozin + Semaglutide Placebo45.055.0
Semaglutide + Canagliflozin Placebo69.630.4

[back to top]

Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no)

Percentage of participants who achieved HbA1c ≤ 6.5% (48 mmol/mol), AACE target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 52

,
InterventionPercentage of participants (Number)
YesNo
Canagliflozin + Semaglutide Placebo26.873.2
Semaglutide + Canagliflozin Placebo62.137.9

[back to top]

Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no)

Percentage of participants who achieved HbA1c < 7.0% (53 millimoles per mole [mmol/mol]), ADA target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 52

,
InterventionPercentage of participants (Number)
YesNo
Canagliflozin + Semaglutide Placebo50.849.2
Semaglutide + Canagliflozin Placebo76.123.9

[back to top]

Change in Haematological Parameter- Leukocytes

Change from baseline (week 0) to week 52 in leukocytes (10^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of leukocytes (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.97
Canagliflozin + Semaglutide Placebo0.98

[back to top]

Change in Haematological Parameter- Haemoglobin

Change from baseline (week 0) to week 52 in haemoglobin (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of haemoglobin (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.99
Canagliflozin + Semaglutide Placebo1.05

[back to top]

Change in Haematological Parameter- Haematocrit

Change from baseline (week 0) to week 52 in haematocrit (%) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of haematocrit (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.99
Canagliflozin + Semaglutide Placebo1.04

[back to top]

Change in Haematological Parameter- Erythrocytes

Change from baseline (week 0) to week 52 in erythrocytes (10^12 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of erythrocytes (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.99
Canagliflozin + Semaglutide Placebo1.04

[back to top]

Change in FPG (Fasting Plasma Glucose)

Change from baseline (week 0) to week 52 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionMillimoles per liter (mmol/L) (Mean)
Semaglutide + Canagliflozin Placebo-2.54
Canagliflozin + Semaglutide Placebo-2.00

[back to top]

Change in Fasting Triglycerides

Change from baseline (week 0) to week 52 in fasting triglycerides (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of triglycerides (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.86
Canagliflozin + Semaglutide Placebo0.92

[back to top]

Change in Fasting Total Cholesterol

Change from baseline (week 0) to week 52 in fasting total cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of total cholesterol (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.96
Canagliflozin + Semaglutide Placebo1.03

[back to top]

Change in Fasting LDL-cholesterol

Change from baseline (week 0) to week 52 in fasting low-density lipoprotein (LDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of LDL-cholesterol (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.96
Canagliflozin + Semaglutide Placebo1.05

[back to top]

Change in Fasting HDL-cholesterol

Change from baseline (week 0) to week 52 in fasting high-density lipoprotein (HDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of HDL-cholesterol (Geometric Mean)
Semaglutide + Canagliflozin Placebo1.04
Canagliflozin + Semaglutide Placebo1.08

[back to top]

Change in Calcitonin

Change from baseline (week 0) to week 52 in calcitonin (nanograms per liter) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of calcitonin (Geometric Mean)
Semaglutide + Canagliflozin Placebo1.08
Canagliflozin + Semaglutide Placebo1.04

[back to top]

Change in Body Weight (kg)

Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionKilogram (kg) (Mean)
Semaglutide + Canagliflozin Placebo-5.7
Canagliflozin + Semaglutide Placebo-4.3

[back to top]

Change in Body Mass Index (BMI)

Change from baseline (week 0) to week 52 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionKilogram per square meter (kg/m^2) (Mean)
Semaglutide + Canagliflozin Placebo-2.0
Canagliflozin + Semaglutide Placebo-1.5

[back to top]

Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure)

Change from baseline (week 0) to week 52 in systolic blood pressure and diastolic blood pressure. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionMillimeters of mercury (mmHg) (Mean)
Systolic blood pressureDiastolic blood pressure
Canagliflozin + Semaglutide Placebo-5.8-2.9
Semaglutide + Canagliflozin Placebo-3.7-1.2

[back to top]

Change in Short Form 36 Health Survey (SF-36): Sub-domains

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) to week 52 in the sub-domain scores is presented. A positive change score indicate an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionScore on a scale (Mean)
Physical FunctioningRole-physicalBodily painGeneral healthSocial functioningRole-emotionalVitalityMental health
Canagliflozin + Semaglutide Placebo2.72.01.53.51.11.22.00.6
Semaglutide + Canagliflozin Placebo1.91.82.53.71.10.83.01.5

[back to top]

Change in Physical Examination

Physical examination parameters are categorised as general appearance; nervous system (central and peripheral); cardiovascular system; gastrointestinal system; skin; respiratory system; lymph node palpation; thyroid gland; left foot; right foot; left leg and right leg. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -2) and week 52 is presented based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week -2, week 52

,
InterventionParticipants (Count of Participants)
General Appearance (week -2) NormalGeneral Appearance (week -2) Abnormal NCSGeneral Appearance (week -2) Abnormal CSGeneral Appearance (week 52) NormalGeneral Appearance (week 52) Abnormal NCSGeneral Appearance (week 52) Abnormal CSNervous System (week -2) NormalNervous System (week -2) Abnormal NCSNervous System (week -2) Abnormal CSNervous System (week 52) NormalNervous System (week 52) Abnormal NCSNervous System (week 52) Abnormal CSCardiovascular System (week-2) NormalCardiovascular System (week -2) Abnormal NCSCardiovascular System (week -2) Abnormal CSCardiovascular System (week52) NormalCardiovascular System (week 52) Abnormal NCSCardiovascular System (week 52) Abnormal CSGastrointestinal System (week -2) NormalGastrointestinal System (week -2) Abnormal NCSGastrointestinal System (week -2) Abnormal CSGastrointestinal System (week 52) NormalGastrointestinal System (week 52) Abnormal NCSGastrointestinal System (week 52) Abnormal CSSkin (week -2) NormalSkin (week -2) Abnormal NCSSkin (week -2) Abnormal CSSkin (week 52) NormalSkin (week 52) Abnormal NCSSkin (week 52) Abnormal CSRespiratory System (week -2) NormalRespiratory System (week -2) Abnormal NCSRespiratory System (week -2) Abnormal CSRespiratory System (week 52) NormalRespiratory System (week 52) Abnormal NCSRespiratory System (week 52) Abnormal CSLymph Node Palpation (week -2) NormalLymph Node Palpation (week -2) Abnormal NCSLymph Node Palpation (week -2) Abnormal CSLymph Node Palpation (week 52) NormalLymph Node Palpation (week 52) Abnormal NCSLymph Node Palpation (week 52) Abnormal CSThyroid Gland (week -2) NormalThyroid Gland (week -2) Abnormal NCSThyroid Gland (week -2) Abnormal CSThyroid Gland (week 52) NormalThyroid Gland (week 52) Abnormal NCSThyroid Gland (week 52) Abnormal CSLeft foot (week -2) NormalLeft foot (week -2) Abnormal NCSLeft foot (week -2) Abnormal CSLeft foot (week 52) NormalLeft foot (week 52) Abnormal NCSLeft foot (week 52) Abnormal CSRight foot (week -2) NormalRight foot (week -2) Abnormal NCSRight foot (week -2) Abnormal CSRight foot (week 52) NormalRight foot (week 52) Abnormal NCSRight foot (week 52) Abnormal CSLeft leg (week -2) NormalLeft leg (week -2) Abnormal NCSLeft leg (week -2) Abnormal CSLeft leg (week 52) NormalLeft leg (week 52) Abnormal NCSLeft leg (week 52) Abnormal CSRight leg (week -2) NormalRight leg (week -2) Abnormal NCSRight leg (week -2) Abnormal CSRight leg (week 52) NormalRight leg (week 52) Abnormal NCSRight leg (week 52) Abnormal CS
Canagliflozin + Semaglutide Placebo335563304332370213325122386803336037716133180323692298401391303363039220337003904033710345445303342348424304323358306314223357307315213
Semaglutide + Canagliflozin Placebo3454612943023602653032123761513187136922131970330620286391383723214139010325003902032600343472293321344453289343348404300224350375301196

[back to top]

Change in HbA1c

Change from baseline (week 0) to week 52 in HbA1c (glycosylated haemoglobin) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first; and 'In-trial' observation period which started at the date of randomisation and include the period after initiation of rescue medication and/or premature trial product discontinuation, if any and ended at the last contact, withdrawal of consent or death, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionPercentage (%) of HbA1c (Mean)
On-treatment without rescue medicationIn-trial
Canagliflozin + Semaglutide Placebo-1.0-1.0
Semaglutide + Canagliflozin Placebo-1.7-1.5

[back to top]

Change in Biochemistry Parameter- Total Bilirubin

Change from baseline (week 0) to week 52 in total bilirubin (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of total bilirubin (Geometric Mean)
Semaglutide + Canagliflozin Placebo1.06
Canagliflozin + Semaglutide Placebo1.13

[back to top]

Change in Biochemistry Parameter- Sodium

Change from baseline (week 0) to week 52 in sodium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of sodium (Geometric Mean)
Semaglutide + Canagliflozin Placebo1.00
Canagliflozin + Semaglutide Placebo1.00

[back to top]

Change in Biochemistry Parameter- Potassium

Change from baseline (week 0) to week 52 in potassium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of potassium (Geometric Mean)
Semaglutide + Canagliflozin Placebo1.00
Canagliflozin + Semaglutide Placebo1.00

[back to top]

Change in Biochemistry Parameter- Lipase

Change from baseline (week 0) to week 52 in lipase (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of lipase (Geometric Mean)
Semaglutide + Canagliflozin Placebo1.25
Canagliflozin + Semaglutide Placebo1.01

[back to top]

Change in Biochemistry Parameter- eGFR

Estimated glomerular filtration rate (eGFR) (milliliters per minute per 1.73 square meters [mL/min/1.73m^2])is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Change from baseline (week 0) to week 52 in eGFR is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of eGFR (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.98
Canagliflozin + Semaglutide Placebo0.96

[back to top]

Change in Haematological Parameter- Thrombocytes

Change from baseline (week 0) to week 52 in thrombocytes (10^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of thrombocytes (Geometric Mean)
Semaglutide + Canagliflozin Placebo1.04
Canagliflozin + Semaglutide Placebo1.00

[back to top]

Change in Biochemistry Parameter- Calcium

Change from baseline (week 0) to week 52 in calcium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of calcium (Geometric Mean)
Semaglutide + Canagliflozin Placebo1.01
Canagliflozin + Semaglutide Placebo1.02

[back to top]

Change in Biochemistry Parameter- AST

Change from baseline (week 0) to week 52 in aspartate aminotransferase (AST) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of AST (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.89
Canagliflozin + Semaglutide Placebo0.86

[back to top]

Change in Biochemistry Parameter- Amylase

Change from baseline (week 0) to week 52 in amylase (units per liter [U/L]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of amylase (Geometric Mean)
Semaglutide + Canagliflozin Placebo1.16
Canagliflozin + Semaglutide Placebo1.09

[back to top]

Change in ECG

The electrocardiogram (ECG) was assessed by the investigator at baseline (week 0) and week 52 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionParticipants (Count of Participants)
Normal (week 0)Abnormal NCS (week 0)Abnormal CS (week 0)Normal (week 52)Abnormal NCS (week 52)Abnormal CS (week 52)
Canagliflozin + Semaglutide Placebo2771170242953
Semaglutide + Canagliflozin Placebo26312632221090

[back to top]

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately

"Change from baseline (week 0) in DTSQ was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the 'on-treatment without rescue medication' observation period." (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionScore on a scale (Mean)
1) Satisfaction with treatment2) Feeling of unacceptably high blood sugars3) Feeling of unacceptably low blood sugars4) Convenience of treatment5) Flexibility of current treatment6) Satisfaction with understanding of diabetes7) Recommending treatment to others8) Satisfaction to continue with present treatmentTotal treatment satisfaction score
Canagliflozin + Semaglutide Placebo1.0-1.80.10.70.70.60.90.84.8
Semaglutide + Canagliflozin Placebo1.4-2.00.10.80.80.80.91.15.8

[back to top]

Change in Control of Eating Questionnaire (CoEQ): Domains

The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control', 'craving for sweet', 'craving for savoury' and 'positive mood'. The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the 'on-treatment without rescue medication' observation period. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionScore on a scale (Mean)
Craving controlCraving for sweetCraving for savouryPositive mood
Canagliflozin + Semaglutide Placebo1.0-0.6-0.90.4
Semaglutide + Canagliflozin Placebo1.0-0.6-1.10.7

[back to top]

Change in CoEQ: Individual Items

The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control', 'craving for sweet', 'craving for savoury' and 'positive mood'. The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the 'on-treatment without rescue medication' observation period. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionScore on a scale (Mean)
How hungry have you feltHow full have you feltHow often have you had cravings (last 7 days)How strong have any cravings beenDifficulty to resist cravingsAte in response to cravingsDifficulty to control eatingDesire to eat savory foodCraving for dairy foodsCraving for starchy foodsCraving for savory foodsDesire to eat sweet foodCraving for chocolateCraving for other sweetsCraving for fruit or fruit juiceFelt happyFelt anxiousFelt alertFelt contented
Canagliflozin + Semaglutide Placebo-0.80.0-1.1-1.1-0.8-0.7-1.2-1.0-0.6-1.1-0.9-1.0-0.4-0.6-0.60.4-0.60.00.5
Semaglutide + Canagliflozin Placebo-1.20.2-0.9-0.9-0.9-0.9-1.5-1.4-0.8-1.4-0.9-0.9-0.3-0.6-0.60.8-0.90.20.8

[back to top]

Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Weeks 0-57

InterventionEpisodes (Number)
Semaglutide + Canagliflozin Placebo25
Canagliflozin + Semaglutide Placebo6

[back to top]

Total Number of Treatment Emergent Adverse Events (TEAEs)

A TEAE is defined as an adverse event with onset in the on-treatment observation period (which started at the date of first dose of trial product and included the period after initiation of rescue medication, if any and excluded the period after premature trial product discontinuation, if any. TEAEs assessed up to approximately 57 weeks is presented. (NCT03136484)
Timeframe: Weeks 0-57

InterventionAdverse events (Number)
Semaglutide + Canagliflozin Placebo1189
Canagliflozin + Semaglutide Placebo1138

[back to top]

Percentage Change in Visceral Fat Mass (%)

Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionPercentage change (Mean)
Semaglutide + Canagliflozin Placebo-0.81
Canagliflozin + Semaglutide Placebo0.16

[back to top]

Percentage Change in Total Lean Mass (%)

Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionPercentage change (Mean)
Semaglutide + Canagliflozin Placebo1.38
Canagliflozin + Semaglutide Placebo1.09

[back to top]

Percentage Change in Total Fat Mass (%)

Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionPercentage change (Mean)
Semaglutide + Canagliflozin Placebo-1.55
Canagliflozin + Semaglutide Placebo-1.21

[back to top]

Eye Examination

Fundus photography or a dilated fundoscopy was performed by the investigator at baseline (week 0) and week 52. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

,
InterventionParticipants (Count of Participants)
Left eye: Normal (week 0)Left eye: Abnormal NCS (week 0)Left eye: Abnormal CS (week 0)Left eye: Normal (week 52)Left eye: Abnormal NCS (week 52)Left eye: Abnormal CS (week 52)Right eye: Normal (week 0)Right eye: Abnormal NCS (week 0)Right eye: Abnormal CS (week 0)Right eye: Normal (week 52)Right eye: Abnormal NCS (week 52)Right eye: Abnormal CS (week 52)
Canagliflozin + Semaglutide Placebo319713228402319704226440
Semaglutide + Canagliflozin Placebo322655231307321665225358

[back to top]

Change in Biochemistry Parameter- ALT

Change from baseline (week 0) to week 52 in alanine aminotransferase (ALT) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of ALT (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.79
Canagliflozin + Semaglutide Placebo0.79

[back to top]

Change in Biochemistry Parameter- ALP

Change from baseline (week 0) to week 52 in alkaline phosphatase (ALP) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of ALP (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.96
Canagliflozin + Semaglutide Placebo0.95

[back to top]

Change in Biochemistry Parameter- Albumin

Change from baseline (week 0) to week 52 in albumin (g/dL) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of albumin (Geometric Mean)
Semaglutide + Canagliflozin Placebo0.99
Canagliflozin + Semaglutide Placebo1.00

[back to top]

Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Weeks 0-57

InterventionParticipants (Number)
Semaglutide + Canagliflozin Placebo6
Canagliflozin + Semaglutide Placebo5

[back to top]

Change in Waist Circumference

Change from baseline (week 0) to week 52 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionCentimeter (cm) (Mean)
Semaglutide + Canagliflozin Placebo-4.2
Canagliflozin + Semaglutide Placebo-3.0

[back to top]

Change in Visceral Fat Mass (kg)

Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

Interventionkg (Mean)
Semaglutide + Canagliflozin Placebo-0.20
Canagliflozin + Semaglutide Placebo-0.13

[back to top]

Percentage Change in Body Weight (%)

Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

InterventionPercentage change (Mean)
Semaglutide + Canagliflozin Placebo-6.2
Canagliflozin + Semaglutide Placebo-4.7

[back to top]

Change in Total Lean Mass (kg)

Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. (NCT03136484)
Timeframe: Week 0, week 52

Interventionkg (Mean)
Semaglutide + Canagliflozin Placebo-2.06
Canagliflozin + Semaglutide Placebo-1.53

[back to top]

Change in Biochemistry Parameter- Creatinine

Change from baseline (week 0) to week 52 in creatinine (micromoles per liter [umol/L]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any. (NCT03136484)
Timeframe: Week 0, week 52

InterventionRatio of creatinine (Geometric Mean)
Semaglutide + Canagliflozin Placebo1.03
Canagliflozin + Semaglutide Placebo1.04

[back to top]

Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL

The percentage of 2 consecutive glucose readings with < 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
InterventionPercentage of readings (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence ABNANA
Treatment Sequence BANANA

[back to top]

Change From Baseline in Time Spent With Glucose Level < 70 mg/dL

Time spent with the glucose level < 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
InterventionMinutes (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence ABNANA
Treatment Sequence BANANA

[back to top]

Change From Baseline in Time Spent With Glucose Level > 140 mg/dL

Time spent with the glucose level > 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
InterventionMinutes (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence AB-231.98-308.68
Treatment Sequence BA-310.41318.23

[back to top]

Change From Baseline in Time Spent With Glucose Level > 180 mg/dL

Time spent with the glucose level > 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
InterventionMinutes (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence AB-338.36-354.63
Treatment Sequence BA-305.69-361.65

[back to top]

Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL

Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
InterventionMinutes (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence AB226.64277.00
Treatment Sequence BA275.64261.57

[back to top]

Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL

Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
InterventionPercent Change (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence AB0.1570.192
Treatment Sequence BA0.1910.182

[back to top]

Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL

Percent change from baseline in time during 24 hours within the glucose levels >140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
InterventionPercent Change (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence AB-0.161-214
Treatment Sequence BA-0.216-0.221

[back to top]

Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL

Percent change from baseline in time during 24 hours within the glucose levels >180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
InterventionPercent Change (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence AB-0.235-0.246
Treatment Sequence BA-0.212-0.251

[back to top]

Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL

Percent change from baseline in time during 24 hours within the glucose levels < 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
InterventionPercent Change (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence ABNANA
Treatment Sequence BANANA

[back to top]

Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1

Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27)

InterventionPercentage of CV (Mean)
Treatment Sequence AB-0.69
Treatment Sequence BA0.24

[back to top]

Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2

Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 2 (Days 66 to 71)

InterventionPercentage of CV (Mean)
Treatment Sequence AB-1.26
Treatment Sequence BA0.77

[back to top]

Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels

2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
Interventionmg/dL (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence AB-47.03-41.12
Treatment Sequence BA-43.36-44.03

[back to top]

Change From Baseline in Fasting Plasma Glucose Levels

Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
Interventionmg/dL (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence AB-32.04-27.69
Treatment Sequence BA-34.48-45.51

[back to top]

Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile

Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
Interventionmg/dL (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence AB-7.64-8.53
Treatment Sequence BA-8.40-7.13

[back to top]

Change From Baseline in Mean 24-hour Glucose Profile

Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. (NCT03267576)
Timeframe: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)

,
Interventionmg/dL (Mean)
Treatment Period 1Treatment Period 2
Treatment Sequence AB-34.81-31.27
Treatment Sequence BA-39.56-41.74

[back to top]

Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12

Change from baseline in KCCQ-TSS was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-TSS was average of domains- symptom frequency and symptom burden, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status. (NCT04252287)
Timeframe: Baseline, Week 12

InterventionScore on a scale (Least Squares Mean)
Placebo4.9
Canagliflozin 100 mg9.2

[back to top]

Change From Baseline in KCCQ Clinical Summary Score at Week 12

Change from baseline in KCCQ-clinical summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status. (NCT04252287)
Timeframe: Baseline, Week 12

InterventionScore on a scale (Least Squares Mean)
Placebo4.7
Canagliflozin 100 mg8.5

[back to top]

Change From Baseline in KCCQ Overall Summary Score at Week 12

Change from baseline in KCCQ-overall summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ- overall summary score was average of domains- physical limitation, total symptoms (average of symptom frequency and symptom burden), quality of life, and social limitation, and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status. (NCT04252287)
Timeframe: Baseline, Week 12

InterventionScore on a scale (Least Squares Mean)
Placebo6.2
Canagliflozin 100 mg9.5

[back to top]

Change From Baseline in Total Daily Step Count at Week 12

Change from baseline in total daily step count at Week 12 was reported in this outcome measure. The number of steps taken per day was measured using a step activity monitor at baseline and throughout the study. Step count was measured from the Fitbit device data. The Fitbit app on the participant's phone collected all data from the Fitbit device. A negative change from baseline indicated a decrease in the number of daily steps. (NCT04252287)
Timeframe: Baseline, Week 12

InterventionDaily step count (Least Squares Mean)
Placebo-74.9
Canagliflozin 100 mg-45.1

[back to top]

Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12

Change from baseline in KCCQ physical limitation score and KCCQ quality of life score were reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 (worst) and 100 (the best possible status), where the higher score reflected better health status. (NCT04252287)
Timeframe: Baseline, Week 12

,
InterventionScore on a scale (Least Squares Mean)
KCCQ-Physical LimitationKCCQ-Quality of Life
Canagliflozin 100 mg7.812.4
Placebo4.89.1

[back to top]

Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24

Percent change from baseline in HbA1c at Weeks 12 and 24 was reported. (NCT04288778)
Timeframe: Baseline, Weeks 12 and 24

InterventionPercent change (Mean)
Percent change at Week 12Percent change at Week 24
Canagliflozin + Metformin Hydrochloride FDC-0.918-0.926

[back to top]

Percentage of Participants With Unexpected Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An adverse event was considered unexpected if the nature or severity was not consistent with the applicable product reference safety information. (NCT04288778)
Timeframe: Baseline (Day 1) up to 24 weeks

InterventionPercentage of participants (Number)
Canagliflozin + Metformin Hydrochloride FDC0

[back to top]

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. TEAEs were defined as events that started on or after the study medication start date and time. (NCT04288778)
Timeframe: Baseline (Day 1) up to 24 weeks

InterventionPercentage of participants (Number)
TEAEsTESAEs
Canagliflozin + Metformin Hydrochloride FDC41.61.1

[back to top]

Percentage of Participants With Adverse Drug Reactions (ADRs)

ADRs were defined as the treatment related TEAEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were defined as events that started on or after the study medication start date and time. (NCT04288778)
Timeframe: Baseline (Day 1) up to 24 weeks

InterventionPercentage of participants (Number)
Canagliflozin + Metformin Hydrochloride FDC10.6

[back to top]