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A Study In Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00256867
First received: November 18, 2005
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.


Condition Intervention Phase
Non-Insulin-Dependent Diabetes Mellitus
 Drug: GSK523338
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 16 Week Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of a New Medication (GSK523338) to Lower LDL-c and HbA1c in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Efficacy of GSK523338 to lower HbA1c and LDL-c

Secondary Outcome Measures:
  • Safety and tolerability of GSK523338 in patients with type 2 diabetes

Estimated Enrollment: 360
Study Start Date: August 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GSK523338
    Other Name: GSK523338
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • A clinical diagnosis type 2 diabetes mellitus.
  • Women must not be pregnant or breastfeeding during the study and 30 days after the study.
  • Must sign an informed consent form at the study clinic.

Exclusion criteria:

  • Severe chronic diseases that would prevent from participating and completing the study by investigator's judgement.
  • Use of an investigational drug within 30 days or 5 half lives before first dose of study medication.
  • Insulin use for > 1 week in past 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256867

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85745
United States, California
GSK Investigational Site
Fresno, California, United States, 93720
United States, Colorado
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
St. Cloud, Florida, United States, 34769
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60607
GSK Investigational Site
Melrose Park, Illinois, United States, 60160
United States, Indiana
GSK Investigational Site
Avon, Indiana, United States, 46123
GSK Investigational Site
Elkhart, Indiana, United States, 46515
United States, Louisiana
GSK Investigational Site
Sunset, Louisiana, United States, 70584
United States, Massachusetts
GSK Investigational Site
Waltham, Massachusetts, United States, 02453
United States, Missouri
GSK Investigational Site
St. Peters, Missouri, United States, 63376
United States, Montana
GSK Investigational Site
Billings, Montana, United States, 59102
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
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43212
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97216
GSK Investigational Site
Portland, Oregon, United States, 97219
GSK Investigational Site
Portland, Oregon, United States, 97239
GSK Investigational Site
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
GSK Investigational Site
Beaver, Pennsylvania, United States, 15009
GSK Investigational Site
Fleetwood, Pennsylvania, United States, 19522
GSK Investigational Site
Jefferson Hills, Pennsylvania, United States, 15025
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19152
United States, South Carolina
GSK Investigational Site
Clinton, South Carolina, United States, 29325
GSK Investigational Site
Columbia, South Carolina, United States, 29201
United States, Tennessee
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
GSK Investigational Site
Bryan, Texas, United States, 77802
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Georgetown, Texas, United States, 78626
GSK Investigational Site
Midland, Texas, United States, 79705
GSK Investigational Site
Plano, Texas, United States, 75093
United States, Virginia
GSK Investigational Site
Burke, Virginia, United States, 22015
GSK Investigational Site
Manassas, Virginia, United States, 20110
United States, Washington
GSK Investigational Site
Bellevue, Washington, United States, 98004
GSK Investigational Site
Spokane, Washington, United States, 99208
GSK Investigational Site
Vancouver, Washington, United States, 98664
Australia, New South Wales
GSK Investigational Site
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
GSK Investigational Site
Keswick, South Australia, Australia, 5035
GSK Investigational Site
Port Lincoln, South Australia, Australia, 5606
Australia, Victoria
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
GSK Investigational Site
Heidelberg West, Victoria, Australia, 3081
GSK Investigational Site
Ringwood East, Victoria, Australia, 3135
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T5N 3Y6
GSK Investigational Site
Edmonton, Alberta, Canada, T5J 3N4
Canada, British Columbia
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3V9
Canada, New Brunswick
GSK Investigational Site
Moncton, New Brunswick, Canada, E1G1A7
Canada, Newfoundland and Labrador
GSK Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 5R3
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
Brampton, Ontario, Canada, L6T 3T1
GSK Investigational Site
Hamilton, Ontario, Canada, L8M 1K7
GSK Investigational Site
North Bay, Ontario, Canada, P1B 2H3
GSK Investigational Site
Sudbury, Ontario, Canada, P3A 1Y8
GSK Investigational Site
Toronto, Ontario, Canada, M3H 5S4
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
GSK Investigational Site
Toronto, Ontario, Canada, M8V 3X8
GSK Investigational Site
Woodstock, Ontario, Canada, N4S 4G3
Canada, Quebec
GSK Investigational Site
Bonaventure, Quebec, Canada, G0C 1E0
GSK Investigational Site
Gatineau, Quebec, Canada, J8Y 6S9
GSK Investigational Site
Granby, Quebec, Canada, J2G 8Z9
GSK Investigational Site
Montreal, Quebec, Canada, H2K 4L5
GSK Investigational Site
Plessisville, Quebec, Canada, G6L 3J1
GSK Investigational Site
Pointe-Claire, Quebec, Canada, H9R 4S3
GSK Investigational Site
Saint Marc Des Carrieres, Quebec, Canada, G0A 4B0
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1V 1V6
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G2
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 4J6
Canada, Saskatchewan
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 7H9
Mexico
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44340
GSK Investigational Site
Cuernavaca, Morelos, Mexico, 62420
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64570
GSK Investigational Site
Mexico, Mexico, 14080
Philippines
GSK Investigational Site
Manila, Philippines, 1008
GSK Investigational Site
Quezon City, Philippines, 1100
GSK Investigational Site
Quezon City, Philippines, 1113
Puerto Rico
GSK Investigational Site
Carolina, Puerto Rico, 00983
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00256867     History of Changes
Other Study ID Numbers: AVS101946
Study First Received: November 18, 2005
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Type 2 diabetes Type II

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013