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

Sponsor:	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

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Locations

United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
GSK Investigational Site
Phoenix, Arizona, United States, 85014
United States, California
GSK Investigational Site
Encinitas, California, United States, 92024
GSK Investigational Site
Fullerton, California, United States, 92835
GSK Investigational Site
Los Banos, California, United States, 93635
United States, Florida
GSK Investigational Site
Orlando, Florida, United States, 32806
GSK Investigational Site
Jacksonville, Florida, United States, 32204
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
St. Cloud, Florida, United States, 34769
United States, Georgia
GSK Investigational Site
Fayetteville, Georgia, United States, 30214
United States, Indiana
GSK Investigational Site
Newburgh, Indiana, United States, 47630
United States, Louisiana
GSK Investigational Site
Slidell, Louisiana, United States, 70461
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14609
GSK Investigational Site
Kingston, New York, United States, 12401
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28210
United States, Ohio
GSK Investigational Site
Mogadore, Ohio, United States, 44260
United States, Pennsylvania
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
GSK Investigational Site
Warminster, Pennsylvania, United States, 18974
United States, Tennessee
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78237
GSK Investigational Site
Beaumont, Texas, United States, 77701
GSK Investigational Site
Midland, Texas, United States, 79705
GSK Investigational Site
San Antonio, Texas, United States, 78221
GSK Investigational Site
Dallas, Texas, United States, 75230
United States, Washington
GSK Investigational Site
Wenatchee, Washington, United States, 98801
GSK Investigational Site
Seattle, Washington, United States, 98108
GSK Investigational Site
Spokane, Washington, United States, 99207
Australia, New South Wales
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
GSK Investigational Site
St Leonards, New South Wales, Australia, 2065
GSK Investigational Site
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Australia, South Australia
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
GSK Investigational Site
Caulfield, Victoria, Australia, 3162
Australia, Western Australia
GSK Investigational Site
Fremantle, Western Australia, Australia, 6959
GSK Investigational Site
Perth, Western Australia, Australia, 6000
Canada, British Columbia
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Canada, New Brunswick
GSK Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 5R3
Canada, Ontario
GSK Investigational Site
Burlington, Ontario, Canada, L7M 4Y1
GSK Investigational Site
Brampton, Ontario, Canada, L6T 3J1
GSK Investigational Site
Kitchener, Ontario, Canada, N2C 2N9
GSK Investigational Site
Peterborough, Ontario, Canada, K9H 5G1
GSK Investigational Site
Toronto, Ontario, Canada, M3J 1N2
GSK Investigational Site
Peterborough, Ontario, Canada, K9J 7B3
GSK Investigational Site
Oshawa, Ontario, Canada, L1H 1C2
GSK Investigational Site
Renfrew, Ontario, Canada, K7V 1P6
GSK Investigational Site
Stoney Creek, Ontario, Canada, L8G 2V6
Canada, Quebec
GSK Investigational Site
Pointe-Claire, Quebec, Canada, H9R 4S3
GSK Investigational Site
Saint Marc Des Carrieres, Quebec, Canada, G0A 4B0
GSK Investigational Site
Plessisville, Quebec, Canada, G6L 3J1
GSK Investigational Site
Montreal, Quebec, Canada, H1V 1X4
GSK Investigational Site
Sainte Jerome, Quebec, Canada, J7Z 5T3
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
GSK Investigational Site
Laval, Quebec, Canada, H7T 2P5
GSK Investigational Site
Montreal, Quebec, Canada, H4N 2W2
GSK Investigational Site
Montreal, Quebec, Canada, H3S 2W1
Canada, Saskatchewan
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 0M5
GSK Investigational Site
Regina, Saskatchewan, Canada, S4P 3X1
Korea, Republic of
GSK Investigational Site
Pusan, Korea, Republic of, 602-739
GSK Investigational Site
Seoul, Korea, Republic of, 139-872
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1311
GSK Investigational Site
Rotorua, New Zealand, 3201
GSK Investigational Site
Christchurch, New Zealand, 8001
GSK Investigational Site
Wellington 6004, New Zealand, 6004

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:	August 27, 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

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 November 27, 2009