A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
Phase 2
Completed
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Drug: GK Activator (2)
- Registration Number
- NCT00266253
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
- adult patients 30-75 years of age;
- type 2 diabetes mellitus;
- individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening.
Exclusion Criteria
- type 1 diabetes mellitus;
- any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 GK Activator (2) - 5 Metformin - 6 Metformin - 1 Metformin - 2 GK Activator (2) - 2 Metformin - 3 GK Activator (2) - 3 Metformin - 4 GK Activator (2) - 4 Metformin - 5 GK Activator (2) -
- Primary Outcome Measures
Name Time Method HbA1c mean change from baseline compared with placebo. Week 12
- Secondary Outcome Measures
Name Time Method AEs, laboratory parameters. Throughout study Additional parameters of glycemic and lipid control. Week 12 Pharmacokinetic and exposure-response relationship Throughout study