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
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Type 2 Diabetes |
| Intervention | Drug: Saxagliptin Drug: Metformin XR Drug: Placebo matching Metformin XR Drug: Metformin XR Drug: Placebo matching Saxagliptin |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT00918138 |
| First Received | June 9, 2009 |
| Last Updated | October 17, 2011 |
| Last verified | October 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 9, 2009 |
|---|---|
| Last Updated Date | October 17, 2011 |
| Start Date | August 2009 |
| Estimated Primary Completion Date | May 2010 |
| Current Primary Outcome Measures | Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4 [Time Frame: Baseline, Week 4] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
|---|---|
| Official Title | A 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination With Metformin XR 1500 mg Versus Up-titrated Metformin XR to 2000 mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Type 2 Diabetes |
| Intervention | Drug: Saxagliptin Tablets, Oral, 5 mg, once daily, 4 weeks Other Names:
Tablets, Oral, 1500 mg, once daily, 4 weeks Other Names: Glucophage XR®Drug: Placebo matching Metformin XR Tablets, Oral, 0 mg, once daily, 4 weeks Drug: Metformin XR Tablets, Oral, 500 mg, once daily, 4 weeks Other Names: Glucophage XR®Drug: Placebo matching Saxagliptin Tablets, Oral, 0 mg, once daily, 4 weeks |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 219 |
| Estimated Completion Date | May 2010 |
| Estimated Primary Completion Date | May 2010 |
| Eligibility Criteria | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Argentina, Israel, Mexico |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00918138 |
|---|---|
| Other Study ID Numbers | CV181-085 |
| Has Data Monitoring Committee | No |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | AstraZeneca |
| Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
| Verification Date | October 2011 |
Locations[ + expand ][ + ]
| Dedicated Phase I, Inc. | Phoenix, Arizona, United States, 85013 |
|---|---|
| Pacific Sleep Medicine Services (Avastra Clinical Trials) | Redlands, California, United States, 92373 |
| Orange County Research Center | Tustin, California, United States, 92780 |
| Clinical Research Of South Florida | Coral Gables, Florida, United States, 33134 |
| Palm Springs Research Institute | Hialeah, Florida, United States, 33012 |
| Healthcare Clinical Data, Inc. | North Miami, Florida, United States, 33161 |
| River Birch Research Alliance, Llc | Blue Ridge, Georgia, United States, 30513 |
| Jasper Clinic, Inc. | Kalamazoo, Michigan, United States, 49007 |
| Clinilabs, Inc. | New York, New York, United States, 10019 |
| Medpace Clinical Pharmacology Unit | Cincinnati, Ohio, United States, 45212 |
| Clinical Trials Of Texas Inc. | San Antonio, Texas, United States, 78229 |
| Advanced Clinical Research | West Jordan, Utah, United States, 84088 |
| Local Institution | Capital Federal, Buenos Aires, Argentina, 1429 |
| Local Institution | Buenos Aires, Argentina, 1425 |
| Local Institution | Beer-Sheva, Israel, 84101 |
| Local Institution | Holon, Israel, 58100 |
| Local Institution | Kfar-Saba, Israel, 44281 |
| Local Institution | Zefat, Israel, 13100 |
| Local Institution | Monterrey, Nuevo Leon, Mexico, 64460 |
| Local Institution | Durango, Mexico, 34075 |
| Local Institution | Durango, Mexico, 34000 |