Diabetes Mellitus, Type 2
Conditions
Keywords
Metformin, AVANDAMET, Type 2 diabetes
Brief summary
This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at week 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48. | — |
Countries
Canada
Outcome results
None listed