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

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

sites

Clinical Trial Facility in Adelaide

Adelaide,

from

Adelaide,