Overview

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

Status:
Completed
Trial end date:
2003-12-01
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 5 to 20 mg/day will be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
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