A Phase II Randomized, Double-Blind, Dose-Ranging Study to Determine the Efficacy, Safety, Tolerability & Pharmacokinetics of RO 205-2349 in Patients With Type 2 Diabetes Mellitus

Hoffmann-La Roche0 sites190 target enrollmentJune 2003

ConditionsDiabetes

InterventionsRO 205-2349

DrugsRO 205-2349

Overview

Phase: Phase 2
Intervention: RO 205-2349
Conditions: Diabetes
Sponsor: Hoffmann-La Roche
Enrollment: 190
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

March 2004

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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