A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 6/3/2016 |
| Start Date: | January 2009 |
| End Date: | April 2010 |
A Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled 12-week Study to Investigate Glycemic Parameters of Efficacy, Safety/ Tolerability and Pharmacokinetics of Five Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus
This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of
RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be
randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or
40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to
take their usual dose of metformin throughout the study.The anticipated time on study
treatment is <=3 months
RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be
randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or
40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to
take their usual dose of metformin throughout the study.The anticipated time on study
treatment is <=3 months
Inclusion Criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes, diagnosed for >=3 months;
- either treated with diet, exercise and stable metformin, or with diet and exercise
alone.
Exclusion Criteria:
- type 1 diabetes mellitus;
- currently or within 2 months prior to screening treated with an oral or injectable
anti-diabetic agent except stable doses of metformin;
- currently or within 6 months prior to screening treated with any PPARgamma agonist;
- uncontrolled hypertension;
- significant pre-diagnosed diabetic complications requiring treatment.
We found this trial at
12
sites
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