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

sites

Clinical Trial Facility in Cleveland Ohio

Cleveland, Ohio

from

Cleveland, OH