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)
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
Summit Research Group, LLC
🇺🇸Stow, Ohio, United States
Synergy San Diego
🇺🇸National City, California, United States
Medical Corporation Ishii Internal Medicine Clinic
🇯🇵Kawaguchi, Saitama, Japan
Medical Corporation Jototowakai Shinkoiwa ekimae sogo Clinic
🇯🇵Katsushika-ku, Tokyo, Japan
Catalina Research Institute
🇺🇸Chino, California, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Ikebukuro Metropolitan Clinic
🇯🇵Toshima-ku, Tokyo, Japan
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Compass Research North
🇺🇸Leesburg, Florida, United States
Calabash Medical Center
🇺🇸Calabash, North Carolina, United States
Premier Research Ltd
🇺🇸Trenton, New Jersey, United States
Regional Clinical Research, Inc
🇺🇸Endwell, New York, United States
Rockwood Medical Clinic
🇺🇸Fort Worth, Texas, United States
Sweet Hope Research Specialty, Inc
🇺🇸Miami Lakes, Florida, United States
M&O Clinical Research LLC
🇺🇸Fort Lauderdale, Florida, United States
PICR Clinic
🇺🇸Atlanta, Georgia, United States
Hope Clinical Research, LLC
🇺🇸Canoga Park, California, United States
National Research Institute
🇺🇸Huntington Park, California, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
Detweiler Family Medicine and Associate, P.C.
🇺🇸Lansdale, Pennsylvania, United States
Medical Corporation Hitomi-kai Motomachi Takatsuka Naika Clinic
🇯🇵Yokohama Naka-ku, Kanagawa, Japan
Medical Corporation Yukeikai Asano Clinic
🇯🇵Kawagoe-shi, Saitama, Japan
Medical Corporation Fusanokai Shimizu Clinic Fusa
🇯🇵Saitama-shi, Saitama, Japan
Medical Corp. SEIKOUKAI New Medical Research System Clinic
🇯🇵Hachioji-shi, Tokyo, Japan
Medical Corporation Souyu-kai Hirahata Clinic
🇯🇵Shibuya-ku, Tokyo, Japan
Advanced Arizona Clinical Research
🇺🇸Tucson, Arizona, United States
Ikeoka Medical Corp. Ikeoka Clinic
🇯🇵Joto-ku, Osaka, Japan
Medical Corporation KEISEIKAI Kajiyama clinic
🇯🇵Ukyou-ku, Kyoto, Japan
Medical Corporation Senrichuo Ekimae Clinic
🇯🇵Toyonaka-shi, Osaka, Japan
Medical Corporation Segawa Hospital
🇯🇵Hikigun Ogawamachi, Saitama, Japan
Medical Corporation Yuhokai Miho-Clinic
🇯🇵Shinagawa-ku, Tokyo, Japan
Phoenix Medical Research Institute LLC
🇺🇸Peoria, Arizona, United States
Medical Corporation Hayashi katagihara Clinic
🇯🇵Nishikyo-ku, Kyoto, Japan
Miyauchi Medical Center
🇯🇵Takatsuki-shi, Osaka, Japan
North Myrtle Beach Family Practice
🇺🇸Myrtle Beach, South Carolina, United States
Medical Corporation IHL Pedi Shiodome Medical Clinic
🇯🇵Minato-ku, Tokyo, Japan
Medical Corporation IHL Shinagawa East One Medical Clinic
🇯🇵Minato-ku, Tokyo, Japan
Kenkokan Suzuki Clinic
🇯🇵Ota-ku, Tokyo, Japan
Infosphere Clinical Research, Inc
🇺🇸West Hills, California, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Diabetes & Endocrinology Consultants PC
🇺🇸Morehead City, North Carolina, United States
Global Medical Research
🇺🇸DeSoto, Texas, United States
Northern California Research
🇺🇸Sacramento, California, United States
Artemis Institute for Clinical Research, LLC
🇺🇸San Diego, California, United States
Compass Research LLC
🇺🇸Orlando, Florida, United States
CTI Research
🇺🇸Cincinnati, Ohio, United States
Columbia Research Group, Inc.
🇺🇸Portland, Oregon, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Sunshine Research Center
🇺🇸Opa-locka, Florida, United States