Study of RO6807952 in Patients With Diabetes Mellitus Type 2

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Adult patients >/= 18 and
• Diagnosis of diabetes mellitus, type 2 for at least 3 months

• Treated with a stable dose of metformin

• Hemoglobin A1c >/=7.0% and
• Fasting plasma glucose
• Body mass index >/=27 kg/m2 and
• Willing and able to maintain existing diet and exercise habits throughout the study

• C-peptide >1.5 ng/mL at screening

Exclusion Criteria:

• History of significant liver or kidney disease

• History of uncontrolled hypertension

• History of significant cardiovascular disease

• History of significant diabetic complications

• History of significant gastrointestinal conditions

• History of weight loss surgery or procedures involving the gastrointestinal tract

• History of chronic or acute pancreatitis