A Study of Single Doses of RO4998452 in Patients With Type 2 Diabetes

A Single-center, Double-blind, Randomized, Cross-over, Placebo-controlled, Single-dose Study to Investigate Glycemic Parameters of Efficacy During 24 Hours, Safety/ Tolerability and Pharmacokinetics of Two Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus

This randomized, double-blind, placebo-controlled, cross-over study will evaluate the glucose concentration and other glycemic parameters of efficacy, and the safety and tolerability and pharmacokinetics of single oral doses of RO4998452 in patients with diabetes mellitus type 2. On 3 treatment days a week apart, patients will each receive orally one of 2 dose levels of RO4998452 or placebo. Anticipated time of study treatment is 3 weeks. Target sample size is <50.

Inclusion Criteria:

• Adult patients, 18-75 years of age
• Type 2 diabetes mellitus, diagnosed for at least 3 months at screening
• Treatment with diet and exercise
• BMI between 27 and 40 kg/m2

Exclusion Criteria:

• Type 1 diabetes
• History of ketoacidosis, hyperosmolar coma, or lactic acidosis
• Renal disease or renal dysfunction
• Evidence of significant diabetic complication
• Currently or within 3 months prior to screening treated with any oral or injectable anti-diabetic agents (exception: insulin injection in emergency situation)
• History of anti-diabetic triple therapy