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

NCT00800176

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Diabetes Mellitus Type 2

Interventions: Placebo, RO4998452, RO4998452, RO4998452, RO4998452

Countries: United States, Australia, Brazil, Canada, Germany, Hong Kong, Japan, Latvia

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

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (67)
  • Phoenix, Arizona, United States
  • Los Angeles, California, United States
  • Palm Springs, California, United States
  • Bradenton, Florida, United States
  • Jacksonville, Florida, United States
  • Atlanta, Georgia, United States
  • Hayden Lake, Idaho, United States
  • Rochester, New York, United States
  • Greensboro, North Carolina, United States
  • Midland, Texas, United States
  • Richmond, Virginia, United States
  • Adelaide, Australia
  • St Leonards, Australia
  • Fortaleza, Brazil
  • Goiânia, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Vancouver, British Columbia, Canada
  • London, Ontario, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Berlin, Germany
  • Falkensee, Germany
  • Lübeck, Germany
  • Mainz, Germany
  • Neuss, Germany
  • Hong Kong, Hong Kong
  • Hong Kong, Hong Kong
  • Fukuoka, Japan
  • + 37 more on CT.gov