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

Roche

Status and phase

Withdrawn

Phase 2

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: RO6811135

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01951183

NP29013

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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