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

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Metformin

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