A Dose-Titration Study 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
- NCT00366379
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Inclusion Criteria
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months prior to screening.
Exclusion Criteria
- type 1 diabetes mellitus;
- treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 5 GK Activator (2) - 4 GK Activator (2) - 2 GK Activator (2) - 3 GK Activator (2) - 1 GK Activator (2) -
- Primary Outcome Measures
Name Time Method Percentage of patients at each dose who achieve FPG <100mg/dL. Throughout study
- Secondary Outcome Measures
Name Time Method Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile. At intervals throughout study AEs, laboratory parameters. Throughout study