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

This study has been completed.

First Received on March 31, 2003. Last Updated on June 23, 2005 History of Changes

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00057304

Purpose

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.

Condition	Intervention	Phase
Diabetes	Drug: Insulin sensitizer	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Ro 205-2349

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057304

Show 46 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00057304 History of Changes
Other Study ID Numbers:	BM17151
Study First Received:	March 31, 2003
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 13, 2012