A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics

This study has been completed.

First Received: September 3, 2003 Last Updated: May 15, 2009 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00067951

Purpose

The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.

Condition	Intervention	Phase
Non-Insulin-Dependent Diabetes Mellitus	Drug: rosiglitazone/metformin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Trial to Evaluate the Safety and Efficacy of Fixed Dose Rosiglitazone/Metformin Combination Therapy in Poorly-Controlled Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Rosiglitazone Rosiglitazone Maleate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Hemoglobin A1c (HbA1c) reduction after 24 weeks of treatment.

Secondary Outcome Measures:

Change in FPG, insulin,C-peptide, insulin sensitivity,beta cell function, free fatty acids, lipids. Change in weight, vital signs, clinical laboratory tests, and adverse experiences.

Estimated Enrollment:	190
Study Start Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Laboratory result for HbA1c >11% or FPG >270mg/dL
Clinical diagnosis of Type II diabetes
Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.

Exclusion Criteria:

Women who are pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067951

Show 68 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	712753/004
Study First Received:	September 3, 2003
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00067951 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Type 2 diabetes mellitus
Hyperglycemia
Hemoglobin A1c
HbA1c

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Hyperglycemia
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Rosiglitazone
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009