Study of RO6807952 in Patients With Diabetes Mellitus Type 2
Phase 2
Terminated
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Registration Number
- NCT01516476
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
Inclusion Criteria
- Adult patients >/= 18 and </=70 years of age
- Diagnosis of diabetes mellitus, type 2 for at least 3 months
- Treated with a stable dose of metformin
- Hemoglobin A1c >/=7.0% and </=10.5% at screening
- Fasting plasma glucose </=240 mg/dL at screening
- Body mass index >/=27 kg/m2 and </=42 kg/m2 at screening
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RO6807952 Arm 2 RO6807952 - RO6807952 Arm 1 RO6807952 - Liraglutide Arm liraglutide - Placebo Arm Placebo -
- Primary Outcome Measures
Name Time Method Change in hemoglobin A1c (HA1c) Baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method Change in fasting plasma glucose Baseline and 12 weeks Safety (incidence of adverse events) 12 weeks