A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00961909

Run by

Hoffmann-La Roche

People needed

122

Starts

2009-06-01

Expected to finish

2010-10-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Anaheim, California, United States
• Study site — Chula Vista, California, United States
• Study site — Fort Myers, Florida, United States
• Study site — Miramar, Florida, United States
• Study site — San Antonio, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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