A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

Status:	Completed
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 65
Updated:	8/3/2016
Start Date:	June 2009
End Date:	October 2010

A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group, 2-Part Study to Investigate the Safety, Tolerability, PK, and PD of Once Weekly RO5095932 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

This randomized, double-blind, placebo-controlled study will assess the efficacy, safety,
tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2
diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously
once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their
current stable doses of metformin.

Inclusion Criteria:

- adult patients, 18-65 years of age

- females who are either surgically sterile or post-menopausal

- type 2 diabetes treated with a stable dose of metformin

- BMI between 25-39kg/m2

- HbA1c between 7 and 10%

- fasting plasma glucose between 7 and 13.3mmol/L

Exclusion Criteria:

- history of clinically significant cardiovascular disease

- history of clinically significant hepatic or renal disease or impairment

- recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues,
amylin analogues and/or DPP-IV inhibitors

We found this trial at

sites

Clinical Trial Facility in Ft. Myers Florida

Ft. Myers, Florida 33908

from

Ft. Myers, FL