A Randomized, Double-blind, Placebo-controlled, Titration Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose and Escalating Doses of RO5095932 in Patients With Type 2 Diabetes Mellitus on Stable Background Therapy
Abstract
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.
Conditions: Diabetes Mellitus Type 2.
Primary outcome: Safety and Tolerability of various doses of RO5095932.
Enrollment: 32 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 32 participants or records.
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