Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
- Registration Number
- NCT00683657
- Lead Sponsor
- AstraZeneca
- Brief Summary
This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- ≥18- and ≤77-years-old
- Type 2 diabetes
- Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
- Glycosylated hemoglobin (A1C) ≥7% and ≤10%
- Body mass index (BMI) ≤40 kg/m2
- 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 Placebo + Metformin Placebo - Saxagliptin 5 mg + Metformin Saxagliptin -
- 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 in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4 Baseline, 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.
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4 Baseline, 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.
Change From Baseline in Mean Daily Glucose at Week 4 Baseline, 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.
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4 Baseline, 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.
Trial Locations
- Locations (14)
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
Dedicated Phase I, Inc.
🇺🇸Phoenix, Arizona, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Irvine Center For Clinical Research, Inc.
🇺🇸Irvine, California, United States
River Birch Research Alliance, Llc
🇺🇸Blue Ridge, Georgia, United States
Jasper Clinic, Inc.
🇺🇸Kalamazoo, Michigan, United States
Covance Cru, Inc.
🇺🇸Portland, Oregon, United States
Dgd Research, Inc.
🇺🇸San Antonio, Texas, United States
Amcr Institute, Inc
🇺🇸Escondido, California, United States
Pacific Sleep Medicine Services (Avastra Clinical Trials)
🇺🇸Redlands, California, United States
Clinilabs, Inc.
🇺🇸New York, New York, United States
Avastra Clinical Trials
🇺🇸Midvale, Utah, United States
Local Institution
🇸🇪Lund, Sweden
Advantage Clinical Research
🇺🇸Santa Ana, California, United States