A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT02390050
- Lead Sponsor
- Theracos
- Brief Summary
The purpose of this study was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. This study was to enroll both treatment naive and those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320 subjects eligible for randomization was to receive bexagliflozin tablets, 5, 10, 20 mg or placebo, once daily for 12 weeks in an outpatient setting.
- Detailed Description
The study was a phase 2b multicenter, double-blind, placebo-controlled parallel group study to assess the effect of once daily bexagliflozin tablets on HbA1c in either treatment-naïve T2DM subjects or in subjects who were treated with one oral anti-diabetic agent. Treatment naïve subjects were eligible if their HbA1c values were between 7% and 8.5% at the screening visit while subjects who were treated with one oral hypoglycemic agent (OHA) were eligible if their HbA1c value was between 6.5% and 8.5% at screening and underwent a 6 or 10 week washout period. In addition, all eligible subjects underwent a two week placebo run-in period and those who showed good compliance in taking study medication (i.e., missed no more than one dose during the run-in period) during this period and whose HbA1c values were between 7 and 8.5% at the end of the run-in period were eligible for randomization.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 292
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bexagliflozin tablets, 20 mg Bexagliflozin tablets Bexagliflozin tablets, 20 mg, once daily by mouth before breakfast Bexagliflozin tablets, 10 mg Bexagliflozin tablets Bexagliflozin tablets, 10 mg, once daily by mouth before breakfast Bexagliflozin tablets, placebo Bexagliflozin tablets, placebo Bexagliflozin tablets, placebo, once daily by mouth before breakfast Bexagliflozin tablets, 5 mg Bexagliflozin tablets Bexagliflozin tablets, 5 mg, once daily by mouth before breakfast
- Primary Outcome Measures
Name Time Method Change in HbA1c After 12 Weeks of Treatment 12 weeks Mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA) with baseline HbA1c as a covariate will be fit to the available data, incorporating all visits at which HbA1c was measured for each subject including scheduled visits at Weeks 2, 6, and 12 as well as unscheduled visits for measurements of HbA1c. Treatment (placebo, 5 mg, 10 mg, 20 mg), study center, prior anti-diabetic treatment status, study visit and treatment-by-visit interaction will be applied as fixed effects and subject as a random effect. The least square mean (LSM) change from baseline to Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes.
- Secondary Outcome Measures
Name Time Method Change in Body Weight Over Time Baseline to Week 2, Week 6 and Week 12 The body weight was analyzed on the full analysis set using the MMRM ANCOVA model used for the primary efficacy analysis.
Change in Systolic and Diastolic Blood Pressure Over Time Baseline to Week 2, Week 6 and Week 12 The systolic blood pressure (SBP) and diastolic blood pressure (DBP) were analyzed on the full analysis set using the same MMRM ANCOVA model used in the primary efficacy analysis.
Proportion of Subjects With HbA1c < 7% Baseline to up to 12 weeks To assess the efficacy of bexagliflozin based on the proportion of subjects who reach the American Diabetes Associate (ADA) and the Japan Diabetes Society target HbA1c of \<7%.
Change in Fasting Plasma Glucose (FPG) Over Time Baseline to Week 2, Week 6 and Week 12 The fasting plasma glucose (FPG) was analyzed on the full analysis set using the same MMRM ANCOVA model used in the primary efficacy analysis.
Change in HbA1c Over Time Baseline to Week 2, Week 6 and Week 12 The least square mean (LSM) change from baseline to Week 2, Week 6 and Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes. The LSM change was calculated by excluding HbA1c data obtained after rescue medication.
Trial Locations
- Locations (50)
Phoenix Medical Research Institute LLC
🇺🇸Peoria, Arizona, United States
Advanced Arizona Clinical Research
🇺🇸Tucson, Arizona, United States
Hope Clinical Research, LLC
🇺🇸Canoga Park, California, United States
Catalina Research Institute
🇺🇸Chino, California, United States
National Research Institute
🇺🇸Huntington Park, California, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
Synergy San Diego
🇺🇸National City, California, United States
Northern California Research
🇺🇸Sacramento, California, United States
Artemis Institute for Clinical Research, LLC
🇺🇸San Diego, California, United States
Infosphere Clinical Research, Inc
🇺🇸West Hills, California, United States
Scroll for more (40 remaining)Phoenix Medical Research Institute LLC🇺🇸Peoria, Arizona, United States