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

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:	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:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Ro 205-2349

U.S. FDA Resources

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

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Locations

United States, Florida

Hollywood, Florida, United States, 33021
United States, North Carolina

Durham, North Carolina, United States, 27710

Morrisville, North Carolina, United States, 27560
United States, Oregon

Portland, Oregon, United States, 97219

Portland, Oregon, United States, 97239
United States, Pennsylvania

Camp Hill, Pennsylvania, United States, 17011
United States, South Carolina

Greer, South Carolina, United States, 29651
United States, Tennessee

Memphis, Tennessee, United States, 38119

Memphis, Tennessee, United States, 38163
United States, Texas

Houston, Texas, United States, 77030

Dallas, Texas, United States, 75230

Midland, Texas, United States, 79705
United States, Virginia

Lebanon, Virginia, United States, 24266

Virginia Beach, Virginia, United States, 23451
Bulgaria

Sofia, Bulgaria, 1233

Sofia, Bulgaria, 1431

Sofia, Bulgaria, 1431

Sofia, Bulgaria, 1606

Pleven, Bulgaria, 5800

Plovdiv, Bulgaria, 4002
Estonia

Tartu, Estonia, 50708

Tartu, Estonia, 50406

Tallinn, Estonia, 10138

VORU, Estonia, 65609
Mexico

Mexico City, Mexico, 06700

Monterrey, Mexico, 64320

Monterrey, Mexico, 64460

Monterrey, Mexico, 64410

PACHUCA, HIDALGO, Mexico, 42039

Guadalajara, Mexico, 44349

GUADALAJARA, JAL., Mexico, 44340

CHIHUAHUA, CHIH., Mexico

Merida, Mexico, 97000
Panama

Panama, Panama
Puerto Rico

Ponce, Puerto Rico, 00732-7994
Romania

Brasov, Romania, 500326

Craiova, Romania, 1100

TARGOVISTE, Romania, 0200

Bucuresti, Romania, 7000

Bucuresti, Romania, 020475

Ploiesti, Romania, 2000

Arad, Romania, 2900

TIRGU-MURES, Romania, 4300

GALATI, Romania, 6200
Switzerland

Meyrin, Switzerland, 1217
United Kingdom

Nottingham, United Kingdom, NG2 3HF

Bracknell, United Kingdom, RG12 1HX

Sponsors and Collaborators

Hoffmann-La Roche

More Information

No publications provided

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 25, 2009