Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: Placebo matching Metformin XR
- Registration Number
- NCT00918138
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
- Type 2 diabetes
- 18-78 years of age
- Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
- Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
- Fasting C-peptide: ≥1.0 ng/mL
- FPG≥126 mg/dl obtained at the Day -7 visit
- Body mass index (BMI): ≤ 40kg/m²
- A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization
- Women of childbearing potential unable or unwilling to use acceptable birth control
- Women who are pregnant or breastfeeding
- Significant cardiovascular history
- Active liver disease
- Renal impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin XR + Metformin XR + matching Saxagliptin placebo Metformin XR (Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo) Saxagliptin + Metformin XR + matching Metformin XR placebo Metformin XR (Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo) Metformin XR + Metformin XR + matching Saxagliptin placebo Placebo matching Saxagliptin (Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo) Saxagliptin + Metformin XR + matching Metformin XR placebo Saxagliptin (Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo) Saxagliptin + Metformin XR + matching Metformin XR placebo Placebo matching Metformin XR (Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo)
- Primary Outcome Measures
Name Time Method Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal) Baseline, Week 4 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.
Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal Baseline, Week 4 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.
Trial Locations
- Locations (13)
Dedicated Phase I, Inc.
🇺🇸Phoenix, Arizona, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
River Birch Research Alliance, Llc
🇺🇸Blue Ridge, Georgia, United States
Clinical Trials Of Texas Inc.
🇺🇸San Antonio, Texas, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Local Institution
🇲🇽Durango, Mexico
Healthcare Clinical Data, Inc.
🇺🇸North Miami, Florida, United States
Clinical Research Of South Florida
🇺🇸Coral Gables, Florida, United States
Pacific Sleep Medicine Services (Avastra Clinical Trials)
🇺🇸Redlands, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Jasper Clinic, Inc.
🇺🇸Kalamazoo, Michigan, United States
Clinilabs, Inc.
🇺🇸New York, New York, United States
Medpace Clinical Pharmacology Unit
🇺🇸Cincinnati, Ohio, United States