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

A Randomized, Double-Blind, Multiple-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4998452 Following Oral Administrations in Patients With Type 2 Diabetes Mellitus

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.

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.