| Outcome Measures: |
Primary: Change From Baseline in HbA1c at Week 24 for Double-blind Group, HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis., Baseline to week 24|Change From Baseline in HbA1c at Week 24 for High Glycemic Group, 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, Baseline to week 24 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group, FPG was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis., Baseline, up to 24 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group, 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, Baseline, up to 24 weeks|Change From Baseline in Systolic Blood Pressure (SBP) at Week 24, Changes from baseline at Week 24 in SBP for the double-blind group and high glycemic group, Baseline to week 24|Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group, 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., Baseline, up to 24 weeks|Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group, 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., Baseline, up to 24 weeks|Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group, Changes in body mass from baseline to week 24 was calculated based on LS means for both bexagliflozin and placebo groups., Baseline to week 24|Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group, 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, Baseline to week 24|Change From Baseline in HbA1c Over Time in Double-blind Treatment Group, 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., Baseline, up to 24 weeks|Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0%, 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., Baseline, up to 24 weeks
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| Locations: |
Clinical Research Site 1232, Birmingham, Alabama, 35205, United States|Clinical Research Site 1378, Birmingham, Alabama, 35242, United States|Clinical Research Site 1269, Foley, Alabama, 36535, United States|Clinical Research Site 1363, Little Rock, Arkansas, 72209, United States|Clinical Research Site 1381, Anaheim, California, 92805, United States|Clinical Research Site 1375, North Hollywood, California, 91606, United States|Clinical Research Site 1365, Norwalk, California, 90650, United States|Clinical Research Site 1382, Norwalk, Connecticut, 06851, United States|Clinical Research Site 1372, Hollywood, Florida, 33024, United States|Clinical Research Site 1362, Palm Springs, Florida, 33461, United States|Clinical Research Site 1373, Pembroke Pines, Florida, 33026, United States|Clinical Research Site 1376, Nampa, Idaho, 83686, United States|Clinical Research Site 1366, Chicago, Illinois, 60602, United States|Clinical Research Site 1294, New Orleans, Louisiana, 70124, United States|Clinical Research Site 1374, Saint Louis, Missouri, 63117, United States|Clinical Research Site 1370, Las Vegas, Nevada, 89104, United States|Clinical Research Site 1009, Berlin, New Jersey, 08009, United States|Clinical Research Site 1037, Trenton, New Jersey, 08611, United States|Clinical Research Site 1286, Albuquerque, New Mexico, 87102, United States|Clinical Research Site 1275, Bronx, New York, 10455, United States|Clinical Research Site 1368, New York, New York, 10036, United States|Clinical Research Site 1019, Portland, Oregon, 97239, United States|Clinical Research Site 1379, Gonzales, Texas, 78629, United States|Clinical Research Site 1369, Houston, Texas, 77051, United States|Clinical Research Site 1371, San Antonio, Texas, 78209, United States|Clinical Research Site 1360, San Antonio, Texas, 78258, United States|Clinical Research Site 6048, Nagoya, Aichi, 456-0058, Japan|Clinical Research Site 6050, Sapporo, Hokkaido, 003-0023, Japan|Clinical Research Site 6041, Koga, Ibaraki, 306-0232, Japan|Clinical Research Site 6029, Atsugi, Kanagawa, 243-0035, Japan|Clinical Research Site 6051, Kamakura, Kanagawa, 547-0055, Japan|Clinical Research Site 6020, Yokohama, Kanagawa, 221-080, Japan|Clinical Research Site 6055, Tokyo, Meguro, 153-0053, Japan|Clinical Research Site 6046, Higashiosaka, Osaka, 577-0803, Japan|Clinical Research Site 6033, Kashiwara, Osaka, 582-0005, Japan|Clinical Research Site 6013, Toyonaka, Osaka, 560-0082, Japan|Clinical Research Site 6052, Kawaguchi, Saitama, 332-0012, Japan|Clinical Research Site 6053, Shimotsuke, Tochigi, 329-0433, Japan|Clinical Research Site 6040, Fukuoka, 819-0006, Japan|Clinical Research Site 6043, Kyoto, 600-8898, Japan|Clinical Research Site 6015, Osaka, 536-0008, Japan|Clinical Research Site 6045, Tokyo, 108-0075, Japan|Clinical Research Site 6047, Tokyo, 166-0003, Japan
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