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

What this study is testing ClinicalTrials.gov NCT01017302 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Placebo Drug

  Subcutenaous once weekly for 4 weeks

• Placebo Drug

  Single subcutaneous dose in week 5

• RO5095932 Drug

  Escalating subcutaneous doses once weekly over a 4 weeks period

• RO5095932 Drug

  Single subcutenaous dose in week 5