Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2004-03-18
• Target enrollment: 0
• Participant gender: All

Summary

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 2 to 5 mg/day will be studied.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Insulin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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