NCT01516476TerminatedPhase 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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 2
- Primary Endpoint
- Change in hemoglobin A1c (HA1c)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Intervention: liraglutide (Drug)
Placebo Arm
Placebo Comparator
Intervention: Placebo (Drug)
RO6807952 Arm 1
Experimental
Intervention: RO6807952 (Drug)
RO6807952 Arm 2
Experimental
Intervention: RO6807952 (Drug)
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)
Investigators
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