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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pleven, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO 205-2349

Drug

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2003
Study completion: 2003
First posted: Apr 1, 2003
Registry last updated: Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed