AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00241605
- Lead Sponsor
- GlaxoSmithKline
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c at week 48.
- Secondary Outcome Measures
Name Time Method Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇦Québec, Canada