An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR. |
|---|---|
| Condition | Type 2 Diabetes |
| Intervention | Drug: Saxagliptin Drug: Metformin XR Drug: Metformin XR |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Responsible Party | AstraZeneca |
| ClinicalTrials.gov Identifier | NCT00960076 |
| First Received | August 14, 2009 |
| Last Updated | August 22, 2011 |
| Last verified | August 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 14, 2009 |
|---|---|
| Last Updated Date | August 22, 2011 |
| Start Date | August 2009 |
| Estimated Primary Completion Date | October 2010 |
| Current Primary Outcome Measures | Change in HbA1c Level From Baseline to Week 18 (LOCF) [Time Frame: Baseline to week 18] [Designated as safety issue: No]Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes |
|---|---|
| Official Title | 18-Week, Multicenter, Randomized, Double-Blind 3b Trial to Evaluate Efficacy/Safety of Saxagliptin in Combo With Metformin XR 1500mg vs Metformin Uptitrated to 2000mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control After Diet/Exercise and a Stable Dose of Metformin XR 1500mg |
| Brief Summary | The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR. |
| 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 5mg oral tablet once daily Other Names: OnglyzaDrug: Metformin XR 500mg oral tablet once daily Drug: Metformin XR 750mg, 2 tablets once daily |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 282 |
| Estimated Completion Date | October 2010 |
| Estimated Primary Completion Date | October 2010 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less than or equal to 1500mg only for at least 8 weeks prior to screening - A1c: 7.5-11% (at screening) - BMI less than or equal to 45 kg/m2 Exclusion Criteria: - Significant cardiovascular history - Active liver disease, renal impairment |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Colombia, Costa Rica, Mexico, Peru |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00960076 |
|---|---|
| Other Study ID Numbers | D1680L00005 |
| Has Data Monitoring Committee | No |
| Information Provided By | AstraZeneca |
| Study Sponsor | AstraZeneca |
| Collaborators | Bristol-Myers Squibb |
| Investigators | Study Director: Boaz Hirschberg, MD AstraZenecaPrincipal Investigator: Vivian Fonseca, MD Tulane University |
| Verification Date | August 2011 |
Locations[ + expand ][ + ]
| Research Site | Jonesboro, Arkansas, United States |
|---|---|
| Research Site | Anaheim, California, United States |
| Research Site | Fountain Valley, California, United States |
| Research Site | Los Angeles, California, United States |
| Research Site | Pasadena, California, United States |
| Research Site | Sacramento, California, United States |
| Research Site | Gainesville, Florida, United States |
| Research Site | Wellington, Florida, United States |
| Research Site | Chicago, Illinois, United States |
| Research Site | Springfield, Illinois, United States |
| Research Site | Indianapolis, Indiana, United States |
| Research Site | St Louis, Missouri, United States |
| Research Site | Salisbury, North Carolina, United States |
| Research Site | Wilmington, North Carolina, United States |
| Research Site | Winston-salem, North Carolina, United States |
| Research Site | Columbus, Ohio, United States |
| Research Site | Marion, Ohio, United States |
| Research Site | Simpsonville, South Carolina, United States |
| Research Site | Bristol, Tennessee, United States |
| Research Site | Alexandria, Virginia, United States |
| Research Site | Burke, Virginia, United States |
| Research Site | Manassas, Virginia, United States |
| Research Site | Barranquilla, Atlantico, Colombia |
| Research Site | Barranquilla, Colombia |
| Research Site | Bogota, Colombia |
| Research Site | Curridabat, San Jose, Costa Rica |
| Research Site | Los Yoses, San Jose, Costa Rica |
| Research Site | Heredia, Costa Rica |
| Research Site | Mexico, D.f., Mexico |
| Research Site | Guadalajara, Jalisco, Mexico |
| Research Site | Zapopan, Jalisco, Mexico |
| Research Site | Cuernavaca, Morelos, Mexico |
| Research Site | Durango, Mexico |
| Research Site | Queretaro, Mexico |
| Research Site | Lima, Peru |