A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

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

Key facts

Study ID

NCT00800176

Run by

Hoffmann-La Roche

People needed

394

Starts

2009-01-22

Expected to finish

2009-10-28

Last updated by the study team

2020-11-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Palm Springs, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Hayden Lake, Idaho, United States
• Study site — Rochester, New York, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Midland, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Adelaide, Australia
• Study site — St Leonards, Australia
• Study site — Fortaleza, Brazil
• Study site — Goiânia, Brazil
• Study site — São Paulo, Brazil
• Study site — São Paulo, Brazil
• Study site — Vancouver, British Columbia, Canada
• Study site — London, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Berlin, Germany
• Study site — Falkensee, Germany
• Study site — Lübeck, Germany
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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