A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is \<6 months. The target sample size is \<100 patients.

Key facts

Study ID

NCT01017302

Run by

Hoffmann-La Roche

People needed

32

Starts

2009-12-01

Expected to finish

2011-08-01

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
• Diabetes mellitus, type 2 for at least 6 months before screening
• On treatment with stable doses of metformin for at least 3 months before screening
• BMI between >/=25 and </=39

You may not qualify if…

• Type 1 diabetes
• Pancreatitis
• Treatment with insulin for more than one week within 3 months prior to study start

Where it is running

• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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