Page last updated: 2024-10-30

metformin and Urinary Tract Infections

metformin has been researched along with Urinary Tract Infections in 27 studies

Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.

Urinary Tract Infections: Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Research Excerpts

ExcerptRelevanceReference
"To examine the effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor that lowers blood glucose by increasing urinary glucose excretion (UGE), on asymptomatic bacteriuria and urinary tract infections (UTIs)."9.16Effect of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, on bacteriuria and urinary tract infection in subjects with type 2 diabetes enrolled in a 12-week, phase 2 study. ( Capuano, G; Nicolle, LE; Usiskin, K; Ways, K, 2012)
"Titrated canagliflozin significantly improved HbA1c, FPG, body weight and SBP, and was generally well tolerated over 26 weeks in patients with T2DM as add-on to metformin and sitagliptin."5.22Efficacy 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)
"We previously reported that dapagliflozin versus placebo as add-on to saxagliptin plus metformin resulted in greater reductions in glycated haemoglobin (A1C), fasting plasma glucose (FPG) and body weight (BW) after 24 weeks of treatment in patients with type 2 diabetes (T2D)."5.22Efficacy and safety of triple therapy with dapagliflozin add-on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes. ( Chen, H; Garcia-Sanchez, R; González González, JG; Hansen, L; Herrera Marmolejo, M; Iqbal, N; Johnsson, E; Mathieu, C, 2016)
"Canagliflozin improved glycaemic control, reduced body weight and systolic blood pressure, and was generally well tolerated in patients aged 55-80 years with T2DM over 104 weeks."5.20Long-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)
"In patients completing 4 years of treatment, dapagliflozin was well tolerated and associated with sustained glycaemic efficacy and greater reductions in body weight and SBP versus glipizide."5.20Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. ( Del Prato, S; Durán-Garcia, S; Maffei, L; Nauck, M; Parikh, S; Rohwedder, K; Theuerkauf, A, 2015)
"Ertugliflozin (1-25 mg/day) improved glycaemic control, body weight and blood pressure in patients with T2DM suboptimally controlled on metformin, and was well tolerated."5.20Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. ( Amin, NB; Jain, SM; Lee, DS; Nucci, G; Rusnak, JM; Wang, X, 2015)
"To examine the effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor that lowers blood glucose by increasing urinary glucose excretion (UGE), on asymptomatic bacteriuria and urinary tract infections (UTIs)."5.16Effect of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, on bacteriuria and urinary tract infection in subjects with type 2 diabetes enrolled in a 12-week, phase 2 study. ( Capuano, G; Nicolle, LE; Usiskin, K; Ways, K, 2012)
"Hypoglycemia was infrequent, with no episodes of major hypoglycemia."2.80Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. ( Cook, W; Hansen, L; Hirshberg, B; Iqbal, N; Li, Y; Rosenstock, J; Zee, P, 2015)
"Patients with type 2 diabetes mellitus (T2DM) using sulphonylurea and metformin received dapagliflozin 10 mg/day or placebo added to therapy for 52 weeks (24-week randomized, double-blind period plus 28-week double-blind extension)."2.80Durability and tolerability of dapagliflozin over 52 weeks as add-on to metformin and sulphonylurea in type 2 diabetes. ( Bowering, K; Johnsson, E; Matthaei, S; Parikh, S; Rohwedder, K; Sugg, J, 2015)
"Treatment with dapagliflozin add-on to saxagliptin plus metformin resulted in a greater mean HbA1c reduction than placebo (-0."2.80Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes. ( Chen, H; Cook, W; Ekholm, E; Hansen, L; Hirshberg, B; Iqbal, N; Li, D; Mathieu, C; Ranetti, AE, 2015)
" Adverse events (AEs) were evaluated throughout 104 weeks."2.79Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. ( Parikh, S; Rohwedder, K; Sugg, J; Wilding, JP; Woo, V, 2014)
" During the 52-week study period, the proportion of patients reporting ≥1 adverse event (AE) was 66."2.78Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy. ( Barnett, AH; Charbonnel, B; Donovan, M; Fleming, D; Iqbal, N; Li, J, 2013)
" The overall results demonstrated that the use of oral antidiabetic agents (analysed separately and together) was not associated with any significantly increased risk of any serious adverse events including hypoglycaemia and gastrointestinal disorders."2.50The safety of dipeptidyl peptidase-4 (DPP-4) inhibitors or sodium-glucose cotransporter 2 (SGLT-2) inhibitors added to metformin background therapy in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. ( Kawalec, P; Mikrut, A; Łopuch, S, 2014)

Research

Studies (27)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's23 (85.19)24.3611
2020's4 (14.81)2.80

Authors

AuthorsStudies
Majhi, RK1
Mohanty, S1
Kamolvit, W1
White, JK1
Scheffschick, A1
Brauner, H1
Brauner, A1
Yang, H1
Choi, E1
Park, E1
Na, E1
Chung, SY1
Kim, B1
Han, SY1
Park, S1
Jeong, J1
Woo, Y1
Choi, YJ1
Shin, S1
Merész, G1
Szabó, S1
Dóczy, V1
Hölgyesi, Á1
Szakács, Z1
Müller-Wieland, D1
Kellerer, M1
Cypryk, K1
Skripova, D1
Rohwedder, K7
Johnsson, E4
Garcia-Sanchez, R3
Kurlyandskaya, R1
Sjöström, CD1
Jacob, S2
Seufert, J2
Dronamraju, N1
Csomós, K1
Rosenstock, J3
Perl, S1
Nauck, M2
del Prato, S3
Meier, JJ1
Durán-García, S3
Elze, M1
Parikh, SJ2
Lapuerta, P1
Zambrowicz, B1
Powell, DR1
Ogbaa, I1
Freiman, J1
Cefalu, WT1
Banks, P1
Frazier, K1
Kelly, M1
Sands, A1
Wilding, JP1
Woo, V1
Sugg, J4
Parikh, S5
Barnett, AH1
Charbonnel, B1
Li, J1
Donovan, M1
Fleming, D1
Iqbal, N4
Jabbour, SA1
Hardy, E1
Nicolle, LE2
Capuano, G2
Fung, A3
Usiskin, K3
Kawalec, P1
Mikrut, A1
Łopuch, S1
Nauck, MA1
Langkilde, AM1
Hansen, L3
Zee, P1
Li, Y1
Cook, W2
Hirshberg, B2
Bode, B1
Stenlöf, K1
Harris, S1
Sullivan, D1
Meininger, G1
Matthaei, S2
Bowering, K2
Grohl, A1
Maffei, L1
Theuerkauf, A1
Amin, NB1
Wang, X1
Jain, SM1
Lee, DS1
Nucci, G1
Rusnak, JM1
Mathieu, C2
Ranetti, AE1
Li, D1
Ekholm, E1
Chen, H2
Sayyid, RK1
Fleshner, NE1
Rodbard, HW1
Aggarwal, N1
Cao, A1
Pfeifer, M1
Alba, M1
Herrera Marmolejo, M1
González González, JG1
Tinahones, FJ1
Gallwitz, B1
Nordaby, M1
Götz, S1
Maldonado-Lutomirsky, M1
Woerle, HJ1
Broedl, UC1
Mustafa, E1
Lai, L1
Lien, YH1
Ways, K1

Clinical Trials (18)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformi[NCT02471404]Phase 4939 participants (Actual)Interventional2015-09-21Completed
A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonyl[NCT00660907]Phase 31,217 participants (Actual)Interventional2008-03-31Completed
A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes W[NCT00673231]Phase 31,240 participants (Actual)Interventional2008-04-30Completed
Effect of Anti-diabetic Drugs on Glycemic Variability. A Comparison Between Gliclazide MR (Modified Release) and Dapagliflozin on Glycemic Variability Measured by Continuous Glucose Monitoring (CGM) in Patients With Uncontrolled Type 2 Diabetes[NCT02925559]Phase 4135 participants (Actual)Interventional2016-10-31Completed
A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Ins[NCT00757588]Phase 3455 participants (Actual)Interventional2008-11-30Completed
Effectiveness of the Treatment With Dapagliflozin and Metformin Compared to Metformin Monotherapy for Weight Loss on Diabetic and Prediabetic Patients With Obesity Class III[NCT03968224]Phase 2/Phase 390 participants (Anticipated)Interventional2018-07-07Recruiting
The Effect of GLP-1 Agonist, SGLT2 Inhibitor and Their Combination on Endothelial Function, Arterial Stiffness and Left Ventricular Deformation in Patients With Type 2 Diabetes With High Cardiovascular Risk[NCT03878706]240 participants (Anticipated)Observational [Patient Registry]2017-11-03Recruiting
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate [NCT00984867]Phase 3833 participants (Actual)Interventional2009-10-31Completed
A Study of the Effects of Dapagliflozin on Ambulatory Aortic Pressure, Arterial Stiffness and Urine Albumin Excretion in Patients With Type 2 Diabetes[NCT02887677]Phase 485 participants (Actual)Interventional2016-10-31Terminated (stopped due to On February 2019 Astra-Zeneca Greece decided to stop the financial support of the study.)
Effectiveness and Tolerability of Novel, Initial Triple Combination Therapy With Xigduo (Dapagliflozin Plus Metformin) and Saxagliptin vs. Conventional Stepwise add-on Therapy in Drug-naïve Patients With Type 2 Diabetes[NCT02946632]Phase 3104 participants (Anticipated)Interventional2016-12-31Not yet recruiting
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combinatio[NCT01606007]Phase 31,282 participants (Actual)Interventional2012-07-31Completed
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate G[NCT01392677]Phase 3311 participants (Actual)Interventional2011-10-31Completed
Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin[NCT03076112]Phase 3170 participants (Actual)Interventional2017-04-25Completed
Prospective, Parallel Goups Study, Aimed to Evaluating Possible Benefits of the Treatment of New Generation Hypoglycaemic Drugs Compared to Sulphonylureas for the Tratment of Type 2 Diabetes Mellitus[NCT04272359]138 participants (Anticipated)Observational [Patient Registry]2019-05-06Recruiting
A 12-Week, Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety, Tolerability and Efficacy Of Once Daily PF-04971729 And Sitagliptin On Glycemic Control And Body Weight In Adult Patients With T[NCT01059825]Phase 2375 participants (Actual)Interventional2010-02-24Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxag[NCT01646320]Phase 3320 participants (Actual)Interventional2012-09-30Completed
A Phase III, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Linagliptin 5 mg Compared to Placebo, Administered as Oral Fixed Dose Combination With Empagliflozin 10 mg or 25 mg for 24 Weeks, in Patients With Type 2 Di[NCT01778049]Phase 3708 participants (Actual)Interventional2013-01-31Completed
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
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

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

Change in FPG from baseline (week 0) to week 52 (NCT02471404)
Timeframe: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis

InterventionFPG (mmol/L) (Least Squares Mean)
Dapaglifozin 10mg-1.62
Saxagliptin 5mg and Dapagliflozin 10mg-2.08
Glimepiride 1mg/2mg/4mg-1.49

Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52

Change in HbA1c from baseline (week 0) to week 52. (NCT02471404)
Timeframe: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis

InterventionHbA1c % (Least Squares Mean)
Dapaglifozin 10mg-0.82
Saxagliptin 5mg and Dapagliflozin 10mg-1.2
Glimepiride 1mg/2mg/4mg-0.99

Change in Total Body Weight From Baseline at Week 52

Change in body weight from baseline (week 0) to week 52 (NCT02471404)
Timeframe: Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis

InterventionWeight (kg) (Least Squares Mean)
Dapaglifozin 10mg-3.54
Saxagliptin 5mg and Dapagliflozin 10mg-3.15
Glimepiride 1mg/2mg/4mg1.76

Number of Patients Rescued

Number (%) of patients rescued. (NCT02471404)
Timeframe: Over the 52 week treatment period

InterventionPercentage of participants (Number)
Dapaglifozin 10mg18.6
Saxagliptin 5mg and Dapagliflozin 10mg8.3
Glimepiride 1mg/2mg/4mg21.4

Patients With at Least One Episode of Confirmed Hypoglycaemia

Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose <=50 mg/dL) during the double-blind treatment period (NCT02471404)
Timeframe: Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis

InterventionPercentage of participants (Number)
Dapaglifozin 10mg0
Saxagliptin 5mg and Dapagliflozin 10mg0.32
Glimepiride 1mg/2mg/4mg4.21

Time to Rescue

The time to rescue (from first dose date after randomisation to start of rescue medication or discontinuation due to lack of glycaemic control) during the 52 week double blind treatment period (NCT02471404)
Timeframe: Over the 52 week treatment period

InterventionWeeks (Median)
Dapaglifozin 10mgNA
Saxagliptin 5mg and Dapagliflozin 10mgNA
Glimepiride 1mg/2mg/4mgNA

Adjusted Mean Change in Body Weight

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

Interventionkg (Least Squares Mean)
Dapagliflozin Plus Metformin-3.22
Glipizide Plus Metformin1.44

Adjusted Mean Change in HbA1c Levels

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

Interventionpercent (Least Squares Mean)
Dapagliflozin Plus Metformin-0.52
Glipizide Plus Metformin-0.52

Proportion of Participants With at Least One Episode of Hypoglycemia

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

InterventionPercentage of participants (Least Squares Mean)
Dapagliflozin Plus Metformin3.5
Glipizide Plus Metformin40.8

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

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

InterventionPercentage of participants (Least Squares Mean)
Dapagliflozin Plus Metformin33.3
Glipizide Plus Metformin2.5

Adjusted Mean Change in Body Weight

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

Interventionkg (Least Squares Mean)
Placebo0.02
Dapagliflozin 2.5mg-0.98
Dapagliflozin 5mg-0.98
Dapagliflozin 10mg-1.67

Adjusted Mean Change in Calculated Mean Daily Insulin Dose

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

InterventionIU/day (Least Squares Mean)
Placebo5.08
Dapagliflozin 2.5mg-1.80
Dapagliflozin 5mg-0.61
Dapagliflozin 10mg-1.16

Adjusted Mean Change in Fasting Plasma Glucose (FPG)

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

Interventionmg/dL (Least Squares Mean)
Placebo3.3
Dapagliflozin 2.5mg-12.5
Dapagliflozin 5mg-18.8
Dapagliflozin 10mg-21.7

Adjusted Mean Change in HbA1c Levels

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

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

Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction

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

InterventionPercentage of participants (Least Squares Mean)
Placebo11.0
Dapagliflozin 2.5mg18.1
Dapagliflozin 5mg16.8
Dapagliflozin 10mg19.7

Proportion of Participants With Lack of Glycemic Control

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

InterventionParticipants (Number)
Placebo54
Dapagliflozin 2.5mg22
Dapagliflozin 5mg24
Dapagliflozin 10mg19

Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])

Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use (NCT00757588)
Timeframe: Baseline to Week 24

InterventionPercentage of change (Mean)
Saxagliptin, 5 mg + Insulin-0.73
Placebo + Insulin-0.32

Change From Baseline in 120-minute PPG Values During an MTT

An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal. (NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg/dL (Mean)
Saxagliptin, 5 mg + Insulin-27.2
Placebo + Insulin-4.2

Change From Baseline in Fasting Plasma Glucose Values

(NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg/dL (Mean)
Saxagliptin, 5 mg + Insulin-10.1
Placebo + Insulin-6.1

Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)

Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline. (NCT00757588)
Timeframe: Baseline to Week 24

InterventionUnits (Mean)
Saxagliptin, 5 mg + Insulin1.71
Placebo + Insulin5.01

Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)

An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal (NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg*min/dL (Mean)
Saxagliptin, 5 mg + Insulin-4548.5
Placebo + Insulin-718.8

Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results

"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions." (NCT00757588)
Timeframe: Baseline to Week 52

InterventionParticipants (Number)
Saxagliptin, 5 mg + Insulin15
Placebo + Insulin11

Percentage of Participants Achieving a Therapeutic Glycemic Response

Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value. (NCT00757588)
Timeframe: Baseline to Week 24

InterventionPercentage of participants (Number)
Saxagliptin, 5 mg + Insulin17.3
Placebo + Insulin6.7

Mean Changes From Baseline in Heart Rate

(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52

,
InterventionBeats per minute (Number)
Week 2 (n=294, 147)Week 4 (n=293, 144)Week 6 (n=280, 141)Week 8 (n=290, 142)Week 12 (n=286, 144)Week 16 (n=278, 139)Week 20 (n=276, 137)Week 24 (n=273, 134)Week 28 (n=264, 132)Week 36 (n=261, 129)Week 44 (n=250, 125)Week 52 (n=246, 125)
Placebo + Insulin-0.7-1.0-0.9-0.70.2-0.60.4-1.0-0.6-0.0-0.70.2
Saxagliptin, 5 mg + Insulin-0.5-0.5-0.5-0.00.3-1.0-0.50.0-1.00.00.2-0.3

Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings

(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52

,
Interventionmm Hg (Number)
Systolic blood pressure (Week 2) (n=294, 147)Systolic blood pressure (Week 4) (n=293, 144)Systolic blood pressure (Week 6) (n=280, 141)Systolic blood pressure (Week 8) (n=290, 142)Systolic blood pressure (Week 12) (n=286, 144)Systolic blood pressure (Week 16) (n=278, 139)Systolic blood pressure (Week 20) (n=276, 137)Systolic blood pressure (Week 24) (n=273, 134)Systolic blood pressure (Week 28) (n=264, 132)Systolic blood pressure (Week 36) (n=261, 129)Systolic blood pressure (Week 44) (n=250, 125)Systolic blood pressure (Week 52) (n=246, 125)Diastolic blood pressure (Week 2) (n=294, 147)Diastolic blood pressure (Week 4) (n=293, 144)Diastolic blood pressure (Week 6) (n=280, 141)Diastolic blood pressure (Week 8) (n=290, 142)Diastolic blood pressure (Week 12) (n=286, 144)Diastolic blood pressure (Week 16) (n=278, 139)Diastolic blood pressure (Week 20) (n=276, 137)Diastolic blood pressure (Week 24) (n=273, 134)Diastolic blood pressure (Week 28) (n=264, 132)Diastolic blood pressure (Week 36) (n=261, 129)Diastolic blood pressure (Week 44) (n=250, 125)Diastolic blood pressure (Week 52) (n=246, 125)
Placebo + Insulin2.30.01.02.42.21.11.3-0.11.83.62.61.01.41.80.32.11.01.31.10.50.20.20.40.1
Saxagliptin, 5 mg + Insulin-1.0-1.2-0.8-0.8-1.7-1.2-0.6-1.5-1.4-0.7-0.60.00.10.00.0-0.5-0.8-1.1-0.7-1.7-1.6-1.2-0.3-0.5

Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs

An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. (NCT00757588)
Timeframe: Baseline to Week 52, continuously

,
InterventionParticipants (Number)
At least 1 AEAt least 1 treatment-related AEDeathsAt least 1 SAEAt least 1 treatment-related SAEDiscontinuations due to SAEsDiscontinuations due to AEs
Placebo + Insulin10834013003
Saxagliptin, 5 mg + Insulin20256225349

Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period

"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4." (NCT00757588)
Timeframe: Baseline and during and up to 14 days after last dose of study drug (in Week 52)

,
InterventionParticipants (Number)
Hemoglobin <8 g/dL (n=300; 150)Hematocrit <0.75*prx (n=300; 150)Platelets <50*10^9 c/L (n=297; 145)Platelets >1.5*ULN (n=297; 145)Leukocytes <2*1000 c/uL (n=300; 150)Neutrophils <1*1000 c/uL (n=296; 150)Eosinophils >0.9*1000 c/uL (n=296; 150)Lymphocytes <=0.75*1000 c/uL (n=296; 150)Alkaline phosphatase >3*prx & >ULN (n=302; 150)Alkaline phosphatase >1.5 ULN (n=302; 150)Aspartate aminotransferase >3* ULN (n=298; 148)Aspartate aminotransferase>5* ULN (n=298; 148)Aspartate aminotransferase >10*ULN (n=298; 148)Aspartate aminotransferase >20*ULN (n=298; 148)Alanine transaminase >3*ULN (n=300; 148)Alanine transaminase >5*ULN (n=300; 148)Alanine transaminase >10*ULN (n=300; 148)Alanine transaminase >20*ULN (n=300; 148)Bilirubin, total >2 mg/dL (n=301; 150)Bilirubin, total >1.5*ULN (n=301; 150)Bilirubin, total >2*ULN (n=301; 150)Blood urea nitrogen >2*prx & >ULN (n=302; 150)Creatinine >2.5 mg/dL (n=303; 150)Glucose, serum fasting <50 mg/dL (n=0; 0)Glucose, serum fasting >500 mg/dL (n=0; 0)Glucose, serum unspecified <50 mg/dL (n=0; 0)Glucose, serum unspecified >500 mg/dL (n=0; 0)Glucose, plasma fasting <50 mg/dL (n=301;150)Glucose, plasma fasting >500 mg/dL (n=301;150)Glucose, plasma unspecified <50 mg/dL (n=272; 133)Glucose, plasma unspecified >500 mg/d (n=272; 133)Sodium, serum <0.9*prx & <=130 mEq/L (n=302; 150)Sodium, serum >1.1*prx & >=150 mEq/L (n=302; 150)Potassium, serum <0.8 prx &<=3.2 mEq/L(n=300; 148)Potassium, serum >1.2*prx&>= 6.0 mEq/L(n=300; 148)Chloride, serum <90 mEq/L (n=302; 150)Chloride, serum >120 mEq/L (n=302; 150)Albumin <0.9*LLN; if prxCreatine kinase >5*ULN (n=301, 148)Uric acid >1.5*ULN; if prx >ULN, >2 (n=0,0)Protein urine (see criteria 1) (n=297,146)Blood urine (see criteria 1) (n=297; 146)Red blood cells urine (see criteria 1) (n=53; 31)White blood cells urine (see criteria 1)(n=115;53)
Placebo + Insulin020010721500003000010700000011100180002032310
Saxagliptin, 5 mg + Insulin22000193210210051000005000005051103810160814835

Percentage of Participants With Reported and Confirmed Hypoglycemia

Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/ (NCT00757588)
Timeframe: Baseline to Week 52

,
InterventionPercentage of Participants (Number)
ReportedConfirmed
Placebo + Insulin24.56.6
Saxagliptin, 5 mg + Insulin19.47.6

Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)

Absolute lymphocyte count=value*10^3 c/uL (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52

,
InterventionParticipants (Number)
Baseline <= 0.75; Week 24 <= 0.75Baseline <= 0.75; Week 24 >0.75- <= 5.00Baseline <= 0.75; Week 24 >5.00Baseline >0.75- <= 5.00; Week 24 <= 0.75Baseline >0.75- <= 5.00; Week 24 >0.75- <= 5.00Baseline >0.75- <= 5.00; Week 24 >5.00Baseline >5.00; Week 24 <= 0.75Baseline >5.00; Week 24 >0.75- <= 5.00Baseline >5.00; Week 24 >5.00Baseline <= 0.75; Week 52 <= 0.75Baseline <= 0.75; Week 52 >0.75- <= 5.00Baseline <= 0.75; Week 52 >5.00Baseline >0.75- <= 5.00; Week 52 <= 0.75Baseline >0.75- <= 5.00; Week 52 >0.75- <= 5.00Baseline >0.75- <= 5.00; Week 52 >5.00Baseline >5.00; Week 52 <= 0.75Baseline >5.00; Week 52 >0.75- <= 5.00Baseline >5.00; Week 52 >5.00
Placebo + Insulin0200148000002001471000
Saxagliptin, 5 mg + Insulin0001293100100002950001

Shift in Platelet Counts From Baseline to Selected Visits (LOCF)

Platelet count=value*10^9 c/L (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52

,
InterventionParticipants (Number)
Baseline <= 100; Week 24 <= 100Baseline <= 100; Week 24 >100 - <= 600Baseline <= 100; Week 24 >600Baseline >100 - <= 600; Week 24 <= 100Baseline >100 - <= 600; Week 24 >100 - <= 600Baseline >100 - <= 600; Week 24 >600Baseline >600; Week 24 <= 100Baseline >600; Week 24 >100 - <= 600Baseline >600; Week 24 >600Baseline <= 100; Week 52 <= 100Baseline <= 100; Week 52 >100 - <= 600Baseline <= 100; Week 52 >600Baseline >100 - <= 600; Week 52 <= 100Baseline >100 - <= 600; Week 52 >100 - <= 600Baseline >100 - <= 600; Week 52 >600Baseline >600; Week 52 <= 100Baseline >600; Week 52 >100 - <= 600Baseline >600; Week 52 >600
Placebo + Insulin0001143000001001440000
Saxagliptin, 5 mg + Insulin0001296000000022950000

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

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

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

Adjusted Mean Change in Body Weight

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

Interventionkg (Least Squares Mean)
Placebo-0.26
Dapagliflozin-2.14

Adjusted Mean Change in Fasting Plasma Glucose (FPG)

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

Interventionmg/dL (Least Squares Mean)
Placebo3.81
Dapagliflozin-24.11

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

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

InterventionPercent (Least Squares Mean)
Placebo0.03
Dapagliflozin-0.80

Adjusted Mean Change in HbA1c Levels

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

InterventionPercent (Least Squares Mean)
Placebo0.04
Dapagliflozin-0.45

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

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

InterventionmmHg (Least Squares Mean)
Placebo-5.12
Dapagliflozin-5.98

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

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

InterventionPercentage of participants (Least Squares Mean)
Placebo16.6
Dapagliflozin35.3

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

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

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

Adjusted Mean Change From Baseline in Body Weight at Week 24

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

InterventionBody weight Kg (Mean)
Arm 1: Saxagliptin+Metformin XR+Placebo0.00
Arm 2: Dapagliflozin+Metformin XR+Placebo-2.39
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR-2.05

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

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

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

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

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

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

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

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

Intervention% of Participants (Number)
Arm 1: Saxagliptin+Metformin XR+Placebo18.3
Arm 2: Dapagliflozin+Metformin XR+Placebo22.2
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR41.4

Adjusted Mean Change From Baseline in FPG

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

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

Adjusted Mean Change From Baseline in HbA1c Levels

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

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

Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure

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

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

Adjusted Mean Change From Baseline in Total Body Weight

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

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

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

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

InterventionPercentage of participants (Least Squares Mean)
Placebo Plus Metformin Plus Sulfonylurea11.1
Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea31.8

Baseline Body Weight

(NCT01059825)
Timeframe: Baseline

Interventionkg (Mean)
Placebo83.78
Ertugliflozin 1 mg83.44
Ertugliflozin 5 mg85.74
Ertugliflozin 10 mg82.28
Ertugliflozin 25 mg81.81
Sitagliptin 100 mg85.52

Baseline Diastolic Blood Pressure

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. (NCT01059825)
Timeframe: Baseline

InterventionmmHg (Mean)
Placebo79.14
Ertugliflozin 1 mg78.95
Ertugliflozin 5 mg78.19
Ertugliflozin 10 mg78.45
Ertugliflozin 25 mg78.61
Sitagliptin 100 mg79.15

Baseline Fasting Plasma Glucose

Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline

Interventionmg/dL (Mean)
Placebo165.3
Ertugliflozin 1 mg162.5
Ertugliflozin 5 mg156.5
Ertugliflozin 10 mg163.3
Ertugliflozin 25 mg171.3
Sitagliptin 100 mg166.2

Baseline Hemoglobin A1c (HbA1c)

HbA1c is measured as percent. (NCT01059825)
Timeframe: Baseline

InterventionPercent (Mean)
Placebo8.08
Ertugliflozin 1 mg8.01
Ertugliflozin 5 mg7.88
Ertugliflozin 10 mg8.13
Ertugliflozin 25 mg8.30
Sitagliptin 100 mg8.24

Baseline Systolic Blood Pressure

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. (NCT01059825)
Timeframe: Baseline

InterventionmmHg (Mean)
Placebo126.7
Ertugliflozin 1 mg126.5
Ertugliflozin 5 mg127.9
Ertugliflozin 10 mg125.8
Ertugliflozin 25 mg124.9
Sitagliptin 100 mg126.6

Change From Baseline in Diastolic Blood Pressure at Week 12

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12

InterventionmmHg (Least Squares Mean)
Placebo0.81
Ertugliflozin 1 mg-1.12
Ertugliflozin 5 mg-1.01
Ertugliflozin 10 mg-3.18
Ertugliflozin 25 mg-1.83
Sitagliptin 100 mg1.68

Change From Baseline in Diastolic Blood Pressure at Week 2

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2

InterventionmmHg (Least Squares Mean)
Placebo-0.57
Ertugliflozin 1 mg-1.25
Ertugliflozin 5 mg-1.26
Ertugliflozin 10 mg-1.97
Ertugliflozin 25 mg-3.01
Sitagliptin 100 mg0.92

Change From Baseline in Diastolic Blood Pressure at Week 4

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4

InterventionmmHg (Least Squares Mean)
Placebo-0.80
Ertugliflozin 1 mg-2.47
Ertugliflozin 5 mg-3.08
Ertugliflozin 10 mg-2.81
Ertugliflozin 25 mg-2.10
Sitagliptin 100 mg-0.51

Change From Baseline in Diastolic Blood Pressure at Week 8

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
Placebo0.80
Ertugliflozin 1 mg-1.40
Ertugliflozin 5 mg-0.69
Ertugliflozin 10 mg-2.23
Ertugliflozin 25 mg-1.20
Sitagliptin 100 mg0.32

Change From Baseline in Fasting Plasma Glucose at Week 12

The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 12

Interventionmg/dL (Least Squares Mean)
Placebo2.76
Ertugliflozin 1 mg-18.23
Ertugliflozin 5 mg-23.06
Ertugliflozin 10 mg-31.47
Ertugliflozin 25 mg-29.26
Sitagliptin 100 mg-17.29

Change From Baseline in Fasting Plasma Glucose at Week 2

The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 2

Interventionmg/dL (Least Squares Mean)
Placebo5.89
Ertugliflozin 1 mg-15.07
Ertugliflozin 5 mg-15.68
Ertugliflozin 10 mg-26.65
Ertugliflozin 25 mg-16.44
Sitagliptin 100 mg-14.69

Change From Baseline in Fasting Plasma Glucose at Week 4

The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 4

Interventionmg/dL (Least Squares Mean)
Placebo5.17
Ertugliflozin 1 mg-16.91
Ertugliflozin 5 mg-22.77
Ertugliflozin 10 mg-27.95
Ertugliflozin 25 mg-26.62
Sitagliptin 100 mg-18.00

Change From Baseline in Fasting Plasma Glucose at Week 8

The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Baseline and Week 8

Interventionmg/dL (Least Squares Mean)
Placebo3.82
Ertugliflozin 1 mg-18.25
Ertugliflozin 5 mg-24.69
Ertugliflozin 10 mg-31.59
Ertugliflozin 25 mg-30.99
Sitagliptin 100 mg-18.93

Change From Baseline in HbA1c at Week 12

HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]). (NCT01059825)
Timeframe: Baseline and Week 12

InterventionPercent (Least Squares Mean)
Placebo-0.11
Ertugliflozin 1 mg-0.56
Ertugliflozin 5 mg-0.80
Ertugliflozin 10 mg-0.73
Ertugliflozin 25 mg-0.83
Sitagliptin 100 mg-0.87

Change From Baseline in HbA1C at Week 2

HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2

InterventionPercent (Least Squares Mean)
Placebo0.00
Ertugliflozin 1 mg-0.14
Ertugliflozin 5 mg-0.29
Ertugliflozin 10 mg-0.22
Ertugliflozin 25 mg-0.17
Sitagliptin 100 mg-0.26

Change From Baseline in HbA1c at Week 4

HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4

InterventionPercent (Least Squares Mean)
Placebo-0.04
Ertugliflozin 1 mg-0.40
Ertugliflozin 5 mg-0.49
Ertugliflozin 10 mg-0.48
Ertugliflozin 25 mg-0.40
Sitagliptin 100 mg-0.48

Change From Baseline in HbA1c at Week 8

HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8

InterventionPercent (Least Squares Mean)
Placebo-0.10
Ertugliflozin 1 mg-0.57
Ertugliflozin 5 mg-0.76
Ertugliflozin 10 mg-0.73
Ertugliflozin 25 mg-0.75
Sitagliptin 100 mg-0.77

Change From Baseline in Systolic Blood Pressure at Week 12

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12

InterventionmmHg (Least Squares Mean)
Placebo-0.55
Ertugliflozin 1 mg-2.69
Ertugliflozin 5 mg-4.03
Ertugliflozin 10 mg-3.43
Ertugliflozin 25 mg-3.93
Sitagliptin 100 mg-1.09

Change From Baseline in Systolic Blood Pressure at Week 2

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2

InterventionmmHg (Least Squares Mean)
Placebo-1.93
Ertugliflozin 1 mg-2.30
Ertugliflozin 5 mg-4.73
Ertugliflozin 10 mg-2.28
Ertugliflozin 25 mg-5.39
Sitagliptin 100 mg-0.91

Change From Baseline in Systolic Blood Pressure at Week 4

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4

InterventionmmHg (Least Squares Mean)
Placebo-2.57
Ertugliflozin 1 mg-3.94
Ertugliflozin 5 mg-5.15
Ertugliflozin 10 mg-5.43
Ertugliflozin 25 mg-3.33
Sitagliptin 100 mg-3.32

Change From Baseline in Systolic Blood Pressure at Week 8

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8

InterventionmmHg (Least Squares Mean)
Placebo-0.44
Ertugliflozin 1 mg-1.53
Ertugliflozin 5 mg-2.85
Ertugliflozin 10 mg-3.04
Ertugliflozin 25 mg-3.30
Sitagliptin 100 mg-2.43

Number of Participants Who Discontinued Study Medication Due to an AE

An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication. (NCT01059825)
Timeframe: Up to 84 days

InterventionParticipants (Number)
Placebo1
Ertugliflozin 1 mg1
Ertugliflozin 5 mg3
Ertugliflozin 10 mg2
Ertugliflozin 25 mg1
Sitagliptin 100 mg1
Metformin Run-in3

Number of Participants Who Experienced an Advere Event (AE)

An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin. (NCT01059825)
Timeframe: Up to 98 days

InterventionParticipants (Number)
Placebo29
Ertugliflozin 1 mg31
Ertugliflozin 5 mg30
Ertugliflozin 10 mg29
Ertugliflozin 25 mg28
Sitagliptin 100 mg30
Metformin Run-in82

Percent Change From Baseline in Body Weight at Week 12

The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 12

InterventionPercent change (Least Squares Mean)
Placebo-0.75
Ertugliflozin 1 mg-1.90
Ertugliflozin 5 mg-2.50
Ertugliflozin 10 mg-2.90
Ertugliflozin 25 mg-2.66
Sitagliptin 100 mg-0.30

Percent Change From Baseline in Body Weight at Week 2

The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 2

InterventionPercent change (Least Squares Mean)
Placebo-0.24
Ertugliflozin 1 mg-0.65
Ertugliflozin 5 mg-1.36
Ertugliflozin 10 mg-1.14
Ertugliflozin 25 mg-1.11
Sitagliptin 100 mg0.21

Percent Change From Baseline in Body Weight at Week 4

The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 4

InterventionPercent change (Least Squares Mean)
Placebo-0.44
Ertugliflozin 1 mg-1.20
Ertugliflozin 5 mg-1.76
Ertugliflozin 10 mg-1.68
Ertugliflozin 25 mg-1.52
Sitagliptin 100 mg0.01

Percent Change From Baseline in Body Weight at Week 8

The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF). (NCT01059825)
Timeframe: Baseline and Week 8

InterventionPercent change (Least Squares Mean)
Placebo-0.62
Ertugliflozin 1 mg-1.65
Ertugliflozin 5 mg-2.18
Ertugliflozin 10 mg-2.30
Ertugliflozin 25 mg-2.40
Sitagliptin 100 mg-0.38

Percentage of Participants Achieving HbA1C <6.5% at Week 12

Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Placebo6.7
Ertugliflozin 1 mg12.0
Ertugliflozin 5 mg20.4
Ertugliflozin 10 mg13.6
Ertugliflozin 25 mg14.9
Sitagliptin 100 mg25.5

Percentage of Participants Achieving HbA1c <7% at Week 12

Laboratory measurements were performed after an overnight fast ≥8 hours in duration. (NCT01059825)
Timeframe: Week 12

InterventionPercentage of participants (Number)
Placebo15.6
Ertugliflozin 1 mg44.0
Ertugliflozin 5 mg42.9
Ertugliflozin 10 mg38.6
Ertugliflozin 25 mg36.2
Sitagliptin 100 mg43.1

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

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

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

Adjusted Mean Change From Baseline in Body Weight at Week 24

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

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

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

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

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

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

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

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

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

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

InterventionPercentage of subjects (Number)
Dapa+Saxa+Met36.7
Pla+Saxa+Met13.3

Change From Baseline of HbA1c After 24 Weeks of Treatment.

"Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term baseline was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as pre-treatment. Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.~Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial." (NCT01778049)
Timeframe: Baseline and 24 weeks

InterventionPercentage of HbA1c (Least Squares Mean)
Lina5 (E10)-0.53
Plc (E10)-0.21
Lina5 (E25)-0.58
Plc (E25)-0.10

Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.

Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24. (NCT01778049)
Timeframe: Baseline and 24 weeks

Interventionmmol/L (Least Squares Mean)
Lina5 (E10)-0.44
Plc (E10)0.21
Lina5 (E25)-0.68
Plc (E25)-0.24

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

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

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

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

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

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

Reviews

3 reviews available for metformin and Urinary Tract Infections

ArticleYear
[Relative frequency of urinary tract infections in patients affected by diabetes mellitus type 2 treated with metformin and SGLT2 inhibitor.
    Orvosi hetilap, 2020, Volume: 161, Issue:13

    Topics: Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Metformin; Network Meta-Analysis; Randomized

2020
The safety of dipeptidyl peptidase-4 (DPP-4) inhibitors or sodium-glucose cotransporter 2 (SGLT-2) inhibitors added to metformin background therapy in patients with type 2 diabetes mellitus: a systematic review and meta-analysis.
    Diabetes/metabolism research and reviews, 2014, Volume: 30, Issue:4

    Topics: Administration, Oral; Diabetes Mellitus, Type 2; Diarrhea; Dipeptidyl-Peptidase IV Inhibitors; Drug

2014
Diabetes Mellitus Type 2: A Driving Force for Urological Complications.
    Trends in endocrinology and metabolism: TEM, 2016, Volume: 27, Issue:5

    Topics: Animals; Carcinoma, Renal Cell; Diabetes Mellitus, Type 2; Humans; Male; Metformin; Prostatic Neopla

2016

Trials

20 trials available for metformin and Urinary Tract Infections

ArticleYear
Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes.
    Diabetes, obesity & metabolism, 2018, Volume: 20, Issue:11

    Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides;

2018
Triple therapy with low-dose dapagliflozin plus saxagliptin versus dual therapy with each monocomponent, all added to metformin, in uncontrolled type 2 diabetes.
    Diabetes, obesity & metabolism, 2019, Volume: 21, Issue:9

    Topics: Adamantane; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipeptides;

2019
[Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin].
    Deutsche medizinische Wochenschrift (1946), 2013, Volume: 138 Suppl 1

    Topics: Aged; Balanitis; Benzhydryl Compounds; Blood Glucose; Body Weight; Candidiasis, Vulvovaginal; Diabet

2013
Study design and rationale of a dose-ranging trial of LX4211, a dual inhibitor of SGLT1 and SGLT2, in type 2 diabetes inadequately controlled on metformin monotherapy.
    Clinical cardiology, 2013, Volume: 36, Issue:7

    Topics: Biomarkers; Blood Glucose; Clinical Protocols; Diabetes Mellitus, Type 2; Double-Blind Method; Femal

2013
Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:2

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus,

2014
Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:2

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus,

2014
Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:2

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus,

2014
Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:2

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus,

2014
Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy.
    Clinical drug investigation, 2013, Volume: 33, Issue:10

    Topics: Adamantane; Adolescent; Adult; Aged; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV

2013
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study.
    Diabetes care, 2014, Volume: 37, Issue:3

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Double-

2014
Urinary tract infection in randomized phase III studies of canagliflozin, a sodium glucose co-transporter 2 inhibitor.
    Postgraduate medicine, 2014, Volume: 126, Issue:1

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Blood Pressure; Body Weight; Canagliflozi

2014
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:11

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re

2014
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:11

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re

2014
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:11

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re

2014
Durability of glycaemic efficacy over 2 years with dapagliflozin versus glipizide as add-on therapies in patients whose type 2 diabetes mellitus is inadequately controlled with metformin.
    Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:11

    Topics: Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; Dose-Re

2014
Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin.
    Diabetes care, 2015, Volume: 38, Issue:3

    Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides;

2015
Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin.
    Diabetes care, 2015, Volume: 38, Issue:3

    Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides;

2015
Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin.
    Diabetes care, 2015, Volume: 38, Issue:3

    Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides;

2015
Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin.
    Diabetes care, 2015, Volume: 38, Issue:3

    Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides;

2015
Long-term efficacy and safety of canagliflozin over 104 weeks in patients aged 55-80 years with type 2 diabetes.
    Diabetes, obesity & metabolism, 2015, Volume: 17, Issue:3

    Topics: Aged; Aged, 80 and over; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Cholesterol, HDL

2015
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
    Diabetes care, 2015, Volume: 38, Issue:3

    Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D

2015
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
    Diabetes care, 2015, Volume: 38, Issue:3

    Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D

2015
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
    Diabetes care, 2015, Volume: 38, Issue:3

    Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D

2015
Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial.
    Diabetes care, 2015, Volume: 38, Issue:3

    Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D

2015
Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data.
    Diabetes, obesity & metabolism, 2015, Volume: 17, Issue:6

    Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Diabetes Mellitus, Type 2; D

2015
Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin.
    Diabetes, obesity & metabolism, 2015, Volume: 17, Issue:6

    Topics: Adult; Aged; Blood Glucose; Blood Pressure; Body Weight; Bridged Bicyclo Compounds, Heterocyclic; Di

2015
Durability and tolerability of dapagliflozin over 52 weeks as add-on to metformin and sulphonylurea in type 2 diabetes.
    Diabetes, obesity & metabolism, 2015, Volume: 17, Issue:11

    Topics: Aged; Benzhydryl Compounds; Blood Glucose; Blood Pressure; Body Weight; Cholesterol; Diabetes Mellit

2015
Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes.
    Diabetes care, 2015, Volume: 38, Issue:11

    Topics: Adamantane; Adult; Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptides;

2015
Efficacy and safety of titrated canagliflozin in patients with type 2 diabetes mellitus inadequately controlled on metformin and sitagliptin.
    Diabetes, obesity & metabolism, 2016, Volume: 18, Issue:8

    Topics: Aged; Blood Glucose; Blood Pressure; Body Weight; Canagliflozin; Diabetes Mellitus, Type 2; Double-B

2016
Efficacy and safety of triple therapy with dapagliflozin add-on to saxagliptin plus metformin over 52 weeks in patients with type 2 diabetes.
    Diabetes, obesity & metabolism, 2016, Volume: 18, Issue:11

    Topics: Adamantane; Adult; Benzhydryl Compounds; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Dipe

2016
Linagliptin as add-on to empagliflozin and metformin in patients with type 2 diabetes: Two 24-week randomized, double-blind, double-dummy, parallel-group trials.
    Diabetes, obesity & metabolism, 2017, Volume: 19, Issue:2

    Topics: Aged; Benzhydryl Compounds; Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Ther

2017
Effect of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, on bacteriuria and urinary tract infection in subjects with type 2 diabetes enrolled in a 12-week, phase 2 study.
    Current medical research and opinion, 2012, Volume: 28, Issue:7

    Topics: Bacteriuria; Blood Glucose; Canagliflozin; Diabetes Mellitus, Type 2; Double-Blind Method; Female; G

2012

Other Studies

4 other studies available for metformin and Urinary Tract Infections

ArticleYear
Metformin strengthens uroepithelial immunity against E. coli infection.
    Scientific reports, 2021, 09-28, Volume: 11, Issue:1

    Topics: Antimicrobial Cationic Peptides; Cathelicidins; Cell Line; Cytokines; Drug Repositioning; Escherichi

2021
Risk of genital and urinary tract infections associated with SGLT-2 inhibitors as an add-on therapy to metformin in patients with type 2 diabetes mellitus: A retrospective cohort study in Korea.
    Pharmacology research & perspectives, 2022, Volume: 10, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Cohort Studies; Databases, Factual; Diabetes Mellitus, Type 2; Dipep

2022
Incident infection risks depending on oral antidiabetic exposure in insulin-treated type 2 diabetes patients.
    Scientific reports, 2023, 10-27, Volume: 13, Issue:1

    Topics: Cohort Studies; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitors; Humans; Hypoglycemic

2023
Rapid recovery from acute kidney injury in a patient with metformin-associated lactic acidosis and hypothermia.
    The American journal of medicine, 2012, Volume: 125, Issue:2

    Topics: Acidosis, Lactic; Acute Kidney Injury; Anti-Bacterial Agents; Comorbidity; Female; Humans; Hypotherm

2012