NCT01516476
Terminated
Phase 2
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
ConditionsDiabetes Mellitus Type 2
Overview
- Phase
- Phase 2
- Intervention
- liraglutide
- Conditions
- Diabetes Mellitus Type 2
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 2
- Primary Endpoint
- Change in hemoglobin A1c (HA1c)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Liraglutide Arm
Intervention: liraglutide
Placebo Arm
Intervention: Placebo
RO6807952 Arm 1
Intervention: RO6807952
RO6807952 Arm 2
Intervention: RO6807952
Outcomes
Primary Outcomes
Change in hemoglobin A1c (HA1c)
Time Frame: Baseline and 12 weeks
Secondary Outcomes
- Change in fasting plasma glucose(Baseline and 12 weeks)
- Safety (incidence of adverse events)(12 weeks)
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