A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 35 - 65 |
| Updated: | 6/3/2016 |
| Start Date: | April 2009 |
| End Date: | March 2010 |
Multi-center, Randomized, Double-blind, 5-arm Parallel Group, Placebo Controlled 4 Week Study to Investigate the Safety, Tolerability and Efficacy of Two Doses Each (Near to Maximum Tolerated Dose and Lower Dose) of RO5093151 Administered Twice Daily (BID Regimen) and RO5027838 Administered Once da
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.
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.
Inclusion Criteria:
- adult patients, 35-65 years of age;
- type 2 diabetes for >=3 months;
- treated for >=3 months with stable dose of metformin >=1.5g/day or maximum tolerated
dose.
Exclusion Criteria:
- history of diabetic ketoacidosis;
- currently or previously treated with insulin;
- currently or within previous 6 months treated with a thiazolidinedione or dual PPAR
agonist;
- treated with lipoprotein-modifying therapy within a month before screening.
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