A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin

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

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.

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