A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• adult patients, 18-65 years of age;

• type 2 diabetes;

• either treated by diet and exercise alone or with metformin.

Exclusion Criteria:

• type 1 diabetes mellitus;

• uncontrolled hypertension;

• clinically severe diabetic complications.