drugset / Trial / NCT00823680

A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

NCT00823680

Phase 2 Completed 110 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is \< 3 months, and the target sample size is 100-500 individuals.

Timeline

Start
2009-04
Primary completion
2009-08
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject RO5027838 Small molecule 50 mg Oral
Subject RO5027838 Small molecule 200 mg Oral
Subject RO5093151 Unknown 10 mg Oral
Subject RO5093151 Unknown 400 mg Oral