A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

• Status: Completed
• Trial end date: 2009-10-28
• Target enrollment: 0
• Participant gender: All

Summary

This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is <=3 months

• 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, diagnosed for >=3 months;

• either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

• type 1 diabetes mellitus;

• currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;

• currently or within 6 months prior to screening treated with any PPARgamma agonist;

• uncontrolled hypertension;

• significant pre-diagnosed diabetic complications requiring treatment.