Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
- Conditions
- Type2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03259789
- Lead Sponsor
- Theracos
- Brief Summary
The purpose of this study is to investigate the effect of bexagliflozin compared to placebo as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).
- Detailed Description
Approximately 300 subjects with inadequately controlled T2DM on metformin were to be recruited from the United States and Japan. Subjects were randomly assigned to receive bexagliflozin tablets, 20 mg, or bexagliflozin tablets, placebo, in a ratio of 1:1 once daily for 24 weeks. Subjects were to continue taking metformin for the duration of the study. The study also enrolled 50 subjects with extremely poorly controlled T2DM on metformin to receive open-label bexagliflozin tablets, 20 mg, for 24 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 351
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bexagliflozin tablets, 20 mg; Double-Blind Bexagliflozin tablets, 20 mg - Bexagliflozin tablets, Placebo; Double Blind Bexagliflozin tablets, placebo - Bexagliflozin Tablets, 20 mg; High Glycemic Group Bexagliflozin tablets, 20 mg -
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c at Week 24 for Double-blind Group Baseline to week 24 HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.
Change From Baseline in HbA1c at Week 24 for High Glycemic Group Baseline to week 24 The change in HbA1c from baseline at Week 24 in High Glycemic Group was calculated by subtracting the mean HbA1c at baseline from the mean HbA1c at Week 24
- Secondary Outcome Measures
Name Time Method Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group Baseline, up to 24 weeks The proportion of subjects who achieved HbA1c \< 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group. The model-adjusted proportion was calculated based on a logistic analysis using Generalized Estimating Equation (GEE) logistic regression that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate. An unstructured correlation structure will be used, or autoregressive if the model with the unstructured structure does not converge.
Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group Baseline, up to 24 weeks The proportion of subjects who achieved HbA1c \< 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group.
Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group Baseline to week 24 Changes in body mass from baseline to week 24 was calculated based on LS means for both bexagliflozin and placebo groups.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group Baseline, up to 24 weeks FPG was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group Baseline, up to 24 weeks The change in FPG from baseline at Week 24 for High Glycemic Group was calculated by subtracting the mean FPG at baseline from the mean FPG at Week 24
Change From Baseline in Systolic Blood Pressure (SBP) at Week 24 Baseline to week 24 Changes from baseline at Week 24 in SBP for the double-blind group and high glycemic group
Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group Baseline to week 24 The change in body mass from baseline at week 24 for High Glycemic group was calculated by subtracting the mean body mass at baseline from the mean body mass at week 24
Change From Baseline in HbA1c Over Time in Double-blind Treatment Group Baseline, up to 24 weeks The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point for each group. The model-adjusted change from baseline was calculated based on a mixed-effects repeated measures analysis that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.
Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0% Baseline, up to 24 weeks The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point in High Glycemic Group.
Trial Locations
- Locations (43)
Clinical Research Site 1382
🇺🇸Norwalk, Connecticut, United States
Clinical Research Site 1373
🇺🇸Pembroke Pines, Florida, United States
Clinical Research Site 1366
🇺🇸Chicago, Illinois, United States
Clinical Research Site 1009
🇺🇸Berlin, New Jersey, United States
Clinical Research Site 1363
🇺🇸Little Rock, Arkansas, United States
Clinical Research Site 1037
🇺🇸Trenton, New Jersey, United States
Clinical Research Site 1376
🇺🇸Nampa, Idaho, United States
Clinical Research Site 6013
🇯🇵Toyonaka, Osaka, Japan
Clinical Research Site 1269
🇺🇸Foley, Alabama, United States
Clinical Research Site 6046
🇯🇵Higashiosaka, Osaka, Japan
Clinical Research Site 1365
🇺🇸Norwalk, California, United States
Clinical Research Site 1372
🇺🇸Hollywood, Florida, United States
Clinical Research Site 6055
🇯🇵Tokyo, Meguro, Japan
Clinical Research Site 1381
🇺🇸Anaheim, California, United States
Clinical Research Site 6033
🇯🇵Kashiwara, Osaka, Japan
Clinical Research Site 6020
🇯🇵Yokohama, Kanagawa, Japan
Clinical Research Site 6040
🇯🇵Fukuoka, Japan
Clinical Research Site 6043
🇯🇵Kyoto, Japan
Clinical Research Site 6015
🇯🇵Osaka, Japan
Clinical Research Site 1368
🇺🇸New York, New York, United States
Clinical Research Site 1375
🇺🇸North Hollywood, California, United States
Clinical Research Site 1362
🇺🇸Palm Springs, Florida, United States
Clinical Research Site 1374
🇺🇸Saint Louis, Missouri, United States
Clinical Research Site 1275
🇺🇸Bronx, New York, United States
Clinical Research Site 1294
🇺🇸New Orleans, Louisiana, United States
Clinical Research Site 1379
🇺🇸Gonzales, Texas, United States
Clinical Research Site 1286
🇺🇸Albuquerque, New Mexico, United States
Clinical Research Site 6048
🇯🇵Nagoya, Aichi, Japan
Clinical Research Site 6029
🇯🇵Atsugi, Kanagawa, Japan
Clinical Research Site 6051
🇯🇵Kamakura, Kanagawa, Japan
Clinical Research Site 6053
🇯🇵Shimotsuke, Tochigi, Japan
Clinical Research Site 6052
🇯🇵Kawaguchi, Saitama, Japan
Clinical Research Site 6045
🇯🇵Tokyo, Japan
Clinical Research Site 6047
🇯🇵Tokyo, Japan
Clinical Research Site 6050
🇯🇵Sapporo, Hokkaido, Japan
Clinical Research Site 6041
🇯🇵Koga, Ibaraki, Japan
Clinical Research Site 1232
🇺🇸Birmingham, Alabama, United States
Clinical Research Site 1378
🇺🇸Birmingham, Alabama, United States
Clinical Research Site 1370
🇺🇸Las Vegas, Nevada, United States
Clinical Research Site 1019
🇺🇸Portland, Oregon, United States
Clinical Research Site 1369
🇺🇸Houston, Texas, United States
Clinical Research Site 1371
🇺🇸San Antonio, Texas, United States
Clinical Research Site 1360
🇺🇸San Antonio, Texas, United States