A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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.