NCT01951183
Withdrawn
Phase 2
A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2A STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-DAILY RO6811135 IN TYPE 2 DIABETIC PATIENTS INADEQUATELY CONTROLLED WITH METFORMIN
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Diabetes Mellitus Type 2
- Sponsor
- Hoffmann-La Roche
- Primary Endpoint
- Change from baseline in HbA1c
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief Summary
This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety and tolerability of RO6811135 in Type 2 diabetic patients treated with a stable dose of metformin.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults between the age of 18 and 65
- •Have been diagnosed with diabetes for at least 3 months and treated with a stable dose of metformin for at least 8 weeks
- •Hemoglobin A1c between 7.2 and 10.5%
- •Fasting plasma glucose less than 250 mg/dL
- •C-peptide greater than 1.5 ng/mL
- •Body mass index (BMI) between 27 and 44
Exclusion Criteria
- •Pregnant or lactating women
- •Type 1 diabetes
- •Had undergone weight loss surgery or weight loss procedure involving the gastrointestinal tract, such as gastric bypass, gastric stapling, or gastric banding
- •Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
- •Significant kidney or liver disease as determined by the investigator
Arms & Interventions
Placebo
Intervention: Placebo
RO6811135
Intervention: RO6811135
Outcomes
Primary Outcomes
Change from baseline in HbA1c
Time Frame: from baseline to Week 12
Secondary Outcomes
- Pharmacokinetics: Area under the concentration-time curve (AUC)(12 weeks)
- Change from baseline in fasting plasma glucose (FPG)(from baseline to Week 12)
- Safety: Incidence of adverse events(19 weeks)
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