A Phase II, Randomized, Double-blind, Placebo-controlled Dose-ranging Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of Ro 205-2349 in Patients With Type 2 Diabetes Mellitus

Hoffmann-La Roche0 sitesDecember 2001

ConditionsDiabetes

DrugsRo 205-2349

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Diabetes
Sponsor: Hoffmann-La Roche
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria 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 5 to 20 mg/day will be studied.

Registry

clinicaltrials.gov

Start Date

December 2001

End Date

December 2003

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

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