| Outcome Measures: |
Primary: Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4, Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value., Baseline, Week 4 | Secondary: Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal), Adjusted mean change from baseline in 2-hour postprandial (after mealtime) plasma glucose two hours after start of the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value., Baseline, Week 4|Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal, FPG measurements were done at baseline, day 14 and 28. At baseline and day 28, the FPG value=plasma glucose value collected 30 minutes prior to the morning meal during the domicile visit., Baseline, Week 4 | Other: Participants With Confirmed Hypoglycemia Events During the Treatment Period, 'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick for glucose \<= 50 mg/dL and associated symptoms., AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.|Participants With Reported Hypoglycemic Adverse Events During Treatment Period, Hypoglycemic events are based upon the Saxagliptin Predefined List of Events, which includes hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. The Hypoglycemic events occurred in less than 5% of the participants and hence do not appear in the adverse events module., AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.
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| Locations: |
Dedicated Phase I, Inc., Phoenix, Arizona, 85013, United States|Pacific Sleep Medicine Services (Avastra Clinical Trials), Redlands, California, 92373, United States|Orange County Research Center, Tustin, California, 92780, United States|Clinical Research Of South Florida, Coral Gables, Florida, 33134, United States|Palm Springs Research Institute, Hialeah, Florida, 33012, United States|Healthcare Clinical Data, Inc., North Miami, Florida, 33161, United States|River Birch Research Alliance, Llc, Blue Ridge, Georgia, 30513, United States|Jasper Clinic, Inc., Kalamazoo, Michigan, 49007, United States|Clinilabs, Inc., New York, New York, 10019, United States|Medpace Clinical Pharmacology Unit, Cincinnati, Ohio, 45212, United States|Clinical Trials Of Texas Inc., San Antonio, Texas, 78229, United States|Advanced Clinical Research, West Jordan, Utah, 84088, United States|Local Institution, Capital Federal, Buenos Aires, 1429, Argentina|Local Institution, Buenos Aires, 1425, Argentina|Local Institution, Beer-Sheva, 84101, Israel|Local Institution, Holon, 58100, Israel|Local Institution, Kfar-Saba, 44281, Israel|Local Institution, Zefat, 13100, Israel|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Durango, 34000, Mexico|Local Institution, Durango, 34075, Mexico
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