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A Study In Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00256867
First Posted: November 22, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Diabetes Mellitus, Type 2 Drug: GSK523338 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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:


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

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Connecticut
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
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
GSK Investigational Site
Springfield, Illinois, United States, 62704
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
Jamaica, New York, United States, 11432
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
Bend, Oregon, United States, 97701
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, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84143
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, T5J 3N4
GSK Investigational Site
Edmonton, Alberta, Canada, T5N 3Y6
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, M8V 3X8
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
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 6S8
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 GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AVS101946
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: AVS101946
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: AVS101946
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: AVS101946
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: AVS101946
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: AVS101946
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: AVS101946
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00256867     History of Changes
Other Study ID Numbers: AVS101946
First Submitted: November 18, 2005
First Posted: November 22, 2005
Last Update Posted: October 12, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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