A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus
Phase 2
Completed
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Drug: GK Activator (2)Drug: Placebo
- Registration Number
- NCT00266240
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. 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
- 267
Inclusion Criteria
- adult patients 30-75 years of age;
- type 2 diabetes mellitus for >3 months before screening;
- treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).
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 3 GK Activator (2) - 2 GK Activator (2) - 1 GK Activator (2) - 4 GK Activator (2) - 5 Placebo -
- Primary Outcome Measures
Name Time Method HbA1c mean change from baseline, compared to placebo. Week 12
- Secondary Outcome Measures
Name Time Method Additional parameters of glycemic and lipid control. Week 12 AEs, laboratory parameters. Throughout study Pharmacokinetic and exposure-response relationship Throughout study