| 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 in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4, Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after 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 in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4, Adjusted mean change from baseline in 2-hour postprandial plasma glucose after 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 in Mean Daily Glucose at Week 4, Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value., Baseline, Week 4|Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4, Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value., Baseline, Week 4
|
| Locations: |
Dedicated Phase I, Inc., Phoenix, Arizona, 85013, United States|Amcr Institute, Inc, Escondido, California, 92026, United States|Irvine Center For Clinical Research, Inc., Irvine, California, 92618, United States|Pacific Sleep Medicine Services (Avastra Clinical Trials), Redlands, California, 92373, United States|Advantage Clinical Research, Santa Ana, California, 92701, United States|Orange County Research Center, Tustin, California, 92780, United States|River Birch Research Alliance, Llc, Blue Ridge, Georgia, 30513, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Jasper Clinic, Inc., Kalamazoo, Michigan, 49007, United States|Clinilabs, Inc., New York, New York, 10019, United States|Covance Cru, Inc., Portland, Oregon, 97239, United States|Dgd Research, Inc., San Antonio, Texas, 78229, United States|Avastra Clinical Trials, Midvale, Utah, 84047, United States|Local Institution, Martinez, Buenos Aires, B1640AOD, Argentina|Local Institution, Holon, 58100, Israel|Local Institution, Jerusalem, 91120, Israel|Local Institution, Kfar-Saba, 44281, Israel|Local Institution, Zerifin, 70300, Israel|Local Institution, Milano, 20132, Italy|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Aguascalientes, 20230, Mexico|Local Institution, Cebu City, 6000, Philippines|Local Institution, Marikina City, 1800, Philippines|Local Institution, Ponce, 00717, Puerto Rico|Local Institution, Gothenburg, 413 45, Sweden|Local Institution, Huddinge, 141 86, Sweden|Local Institution, Lund, 221 85, Sweden
|
