A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
Phase 2
Completed
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Drug: GK Activator (2)
- Registration Number
- NCT00316758
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 259
Inclusion Criteria
- type 2 diabetic patients who have completed studies BM18248 or BM18249;
- patients considered by the investigator to be suitable for long term treatment with GK Activator (2).
Exclusion Criteria
- type 1 diabetes mellitus;
- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 GK Activator (2) - 1 Metformin -
- Primary Outcome Measures
Name Time Method AEs, laboratory parameters, ECG. Throughout study
- Secondary Outcome Measures
Name Time Method Mean change from original baseline in HbA1c, FPG, lipid profile. Throughout study