A Study of RO6811135 in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Metformin
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/23/2013 |
| Start Date: | November 2013 |
| End Date: | September 2014 |
| Contact: | Reference Study ID Number: NP29013 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | global.rochegenentechtrials@roche.com |
| Phone: | 888-662-6728 (U.S. Only) |
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
We found this trial at
10
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