Study of RO6807952 in Patients With Diabetes Mellitus Type 2
| Status: | Terminated |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 8/3/2016 |
| Start Date: | November 2011 |
| End Date: | January 2012 |
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of RO6807952 in Type 2 Diabetic Patients Inadequately Controlled With Metformin Alone
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.
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.
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
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