Status:
COMPLETED
A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2009
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT00800176
Start Date
January 22 2009
End Date
October 28 2009
Last Update
November 18 2020
Active Locations (67)
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1
Phoenix, Arizona, United States, 85015
2
Los Angeles, California, United States, 90057
3
Palm Springs, California, United States, 92262
4
Bradenton, Florida, United States, 34208