AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus
Overview[ - collapse ][ - ]
| Purpose | This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: rosiglitazone/metformin |
| Phase | Phase 4 |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT00241605 |
| First Received | October 17, 2005 |
| Last Updated | July 11, 2013 |
| Last verified | July 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 17, 2005 |
|---|---|
| Last Updated Date | July 11, 2013 |
| Start Date | June 2003 |
| Estimated Primary Completion Date | December 2005 |
| Current Primary Outcome Measures | Change from baseline in HbA1c at week 48. |
| Current Secondary Outcome Measures | Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48. |
Descriptive Information[ + expand ][ + ]
| Brief Title | AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus |
|---|---|
| Official Title | AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin. |
| Brief Summary | This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: rosiglitazone/metformin Other Names: rosiglitazone/metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 600 |
| Estimated Completion Date | December 2005 |
| Estimated Primary Completion Date | December 2005 |
| Eligibility Criteria | Inclusion Criteria: - Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening). - Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening. - Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures. Exclusion Criteria: - Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones. - Have a known hypersensitivity to thiazolidinediones or biguanides. - Currently using insulin or any oral anti-diabetic agent other than metformin. - History of metabolic acidosis. - History of substance abuse. - Have active cancer other than localized squamous or basal cell carcinoma. - Chronic disease requiring treatment with corticosteroids. - Other criteria will be evaluated at the screening visit. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00241605 |
|---|---|
| Other Study ID Numbers | 712753/008 |
| Has Data Monitoring Committee | No |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
| Verification Date | July 2012 |