Status:
COMPLETED
AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 25 2003
Trial Type :
INTERVENTIONAL
End Date :
December 16 2005
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00241605
Start Date
June 25 2003
End Date
December 16 2005
Last Update
March 21 2018
Active Locations (91)
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1
GSK Investigational Site
Calgary, Alberta, Canada, T1Y 3R6
2
GSK Investigational Site
Calgary, Alberta, Canada, T1Y 6J2
3
GSK Investigational Site
Calgary, Alberta, Canada, T2A 0P9
4
GSK Investigational Site
Calgary, Alberta, Canada, T2L 2V9