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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Subcutenaous once weekly for 4 weeks
Single subcutaneous dose in week 5
Escalating subcutaneous doses once weekly over a 4 weeks period
Single subcutenaous dose in week 5
Unnamed facility
San Antonio, Texas, United States
Safety and Tolerability of various doses of RO5095932
Time frame: Weeks 1-4, 6, 8
Safety and Tolerability of a single dose of RO5095932
Time frame: Week 5, 6, 8
Pharmacokinetics: blood concentration
Time frame: Weeks 1-4, 6, 8
Pharmacodynamics: glucose, insulin, C-peptide
Time frame: Weeks 1-4, 6, 8
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