Study of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus

Completed · Phase 2

Conditions studied: Diabetes

In brief

The objective of the study is to determine the dose(s) of Ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. Doses of 5 to 20 mg/day will be studied.

Key facts

Study ID

NCT00057317

Run by

Hoffmann-La Roche

Starts

2001-12-01

Expected to finish

2003-12-01

Last updated by the study team

2016-08-24

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 35 to 75
• Type 2 diabetes for longer than 3 months
• HbA1c (glycosylated hemoglobin A1c) greater than 7.0% at screening
• FPG (fasting plasma glucose) greater than 126 mg/dL at screening
• BMI (body mass index) less than 40 kg/square meter

You may not qualify if…

• Type I diabetes
• Type 2 diabetes patients currently treated with insulin
• Type 2 diabetes patients currently or previously treated with Actos, Avandia or Rezulin
• FPG (fasting plasma glucose) greater than 270 mg/dL at baseline
• Impaired liver or kidney function
• Triglycerides greater than 600 mg/dL
• Uncontrolled hypertension
• Pregnant or lactating women
• Women not using adequate contraception

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Encino, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Fremont, California, United States
• Study site — Fresno, California, United States
• Study site — Irvine, California, United States
• Study site — Modesto, California, United States
• Study site — Pasadena, California, United States
• Study site — San Bruno, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Sunnyvale, California, United States
• Study site — Hamden, Connecticut, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Lawrenceville, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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