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Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00329225
First received: May 22, 2006
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
This 24-week study will compare the effects of adding the drug rosiglitazone (2mg and 4mg) or placebo to insulin in patients with Type 2 diabetes mellitus (non-insulin-dependent) who have not achieved their blood glucose goal using insulin alone. This study requires a total of seven visits during 28 weeks.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: rosiglitazone
Phase 4

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 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone (2mg and 4mg) Compared to Insulin Plus Placebo for 24 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled on Insulin

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HbA1c at each visit [ Time Frame: 28 Weeks ]

Secondary Outcome Measures:
  • FPG at each visit C-peptide at each visit lipids at each visit BNP at each visit CRP at each visit PAI-1 at each visit MMP-9 at each visit [ Time Frame: 28 Weeks ]

Enrollment: 630
Study Start Date: September 2002
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have Type II diabetes mellitus (non-insulin-dependent).
  • Females must be post-menopausal (> 12 months without a menstrual period), surgically sterile, or must be using oral contraceptive, Norplant, Depo-provera, an IUD, or a diaphragm with spermicide or condoms. Females of childbearing potential must use acceptable contraceptive measures for at least one month prior to screening and for 30 days after completing the study.
  • Must have been on insulin therapy alone continuously for at least 8 weeks prior to screening (minimum dose of 30 units per day). Patients taking insulin in combination with a single oral antidiabetic agent may have their oral agent discontinued and their insulin dose optimized over an 8 week period prior to screening if they are considered good study candidates in all other respects.
  • HbA1c > 7.5% at Pre-screen or at Screen for subjects who discontinue their antidiabetic agent at pre-screening.
  • Provide signed Informed Consent.

Exclusion Criteria:

  • Females who are lactating, pregnant, or planning to become pregnant.
  • Use of any drug called a thiazolidinedione within 6 months prior to screening, or more than one oral antidiabetic agent (including combinations of agents such as Glucovance) in combination with insulin in the 3 months prior to screening.
  • Use of any investigational drug for blood glucose control within 3 months of screening regardless of the treatment regimen, or use of any other investigational agent within 30 days preceding study entry.
  • Use of niacin (not including doses found in multivitamins) or oral corticosteroids within 3 months of screening.
  • Patients with ongoing swelling due to fluid accumulation or history of such requiring treatment with a drug in the 12 months prior to screening.
  • Patients with a documented history of significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to the drugs called thiazolidinediones or similar drugs, or with prior fluid related intolerability to thiazolidinediones.
  • Presence of clinically significant kidney or liver disease.
  • Anemia.
  • Presence of unstable or severe angina or coronary insufficiency.
  • Patients with ongoing CHF (chronic heart failure) or history of CHF.
  • Recent history or suspicion of current drug abuse or alcohol abuse.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329225

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35205
GSK Investigational Site
Birmingham, Alabama, United States, 35234
GSK Investigational Site
Fairfield, Alabama, United States, 35064
GSK Investigational Site
Fultondale, Alabama, United States, 35068
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Montgomery, Alabama, United States, 36106
United States, Arizona
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Phoenix, Arizona, United States, 85016
GSK Investigational Site
Phoenix, Arizona, United States, 85029
United States, Arkansas
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
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Concord, California, United States, 94520
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Fresno, California, United States, 93720
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Garden Grove, California, United States, 92840
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La Jolla, California, United States, 92037
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Long Beach, California, United States, 90806
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Los Angeles, California, United States, 90059
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Pasadena, California, United States, 91105
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Sacramento, California, United States, 95825
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Sacramento, California, United States, 95841
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Walnut Creek, California, United States, 94598
GSK Investigational Site
West Hills, California, United States, 91307
United States, Colorado
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Centennial, Colorado, United States, 80112
GSK Investigational Site
Denver, Colorado, United States, 80209
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Longmont, Colorado, United States, 80501
United States, Connecticut
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Hamden, Connecticut, United States, 06518
United States, District of Columbia
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Washington, District of Columbia, United States, 20010
United States, Florida
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Boynton Beach, Florida, United States, 33437
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Deland, Florida, United States, 32720
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Fort Meyers, Florida, United States, 33907
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32204
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Miami, Florida, United States, 33136
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Miami, Florida, United States, 33156
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Ocala, Florida, United States, 34471
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Pembroke Pines, Florida, United States, 33024
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Sarasota, Florida, United States, 34239
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West Palm Beach, Florida, United States, 33401
United States, Georgia
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Atlanta, Georgia, United States, 30328
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Atlanta, Georgia, United States, 30342
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Augusta, Georgia, United States, 30904
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Blue Ridge, Georgia, United States, 30513
United States, Hawaii
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Honolulu, Hawaii, United States, 96813
GSK Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Idaho
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Idaho Falls, Idaho, United States, 83404
United States, Illinois
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Chicago, Illinois, United States, 60607
GSK Investigational Site
Chicago, Illinois, United States, 60610
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Gurnee, Illinois, United States, 60031
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Melrose Park, Illinois, United States, 60160
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Orland Park, Illinois, United States, 60462
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Springfield, Illinois, United States, 62704
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Vernon Hills, Illinois, United States, 60061
United States, Indiana
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Evansville, Indiana, United States, 47714
GSK Investigational Site
Indianapolis, Indiana, United States, 46250
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Kansas
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Wichita, Kansas, United States, 67203
GSK Investigational Site
Wichita, Kansas, United States, 67208
United States, Kentucky
GSK Investigational Site
Madison, Kentucky, United States, 42431
United States, Louisiana
GSK Investigational Site
Lake Charles, Louisiana, United States, 70601
GSK Investigational Site
Marrero, Louisiana, United States, 70072
GSK Investigational Site
Slidell, Louisiana, United States, 70458
GSK Investigational Site
Slidell, Louisiana, United States, 70461
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21204
GSK Investigational Site
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
GSK Investigational Site
Haverhill, Massachusetts, United States, 01831-2451
GSK Investigational Site
Taunton, Massachusetts, United States, 02780
United States, Michigan
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Cadillac, Michigan, United States, 49601
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Troy, Michigan, United States, 48098
United States, Mississippi
GSK Investigational Site
Picayune, Mississippi, United States, 39466
United States, Missouri
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
GSK Investigational Site
Springfield, Missouri, United States, 65807
GSK Investigational Site
St. Louis, Missouri, United States, 63108
United States, Montana
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Butte, Montana, United States, 59701
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
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Henderson, Nevada, United States, 89014
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Las Vegas, Nevada, United States, 89104
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Las Vegas, Nevada, United States, 89119
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Pahrump, Nevada, United States, 89048
United States, New Jersey
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Hillsborough, New Jersey, United States, 08844
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Kenilworth, New Jersey, United States, 07033
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Martinsville, New Jersey, United States, 08836
United States, New Mexico
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Albuquerque, New Mexico, United States, 87108
United States, New York
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Brooklyn, New York, United States, 11216
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Buffalo, New York, United States, 14209
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Cooperstown, New York, United States, 13326
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Fulton, New York, United States, 13009
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Johnson City, New York, United States, 13790
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New Hyde Park, New York, United States, 11042
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New York, New York, United States, 10016
GSK Investigational Site
New York, New York, United States, 10024
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Staten Island, New York, United States, 10301
United States, North Carolina
GSK Investigational Site
Cary, North Carolina, United States, 27511
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Charlotte, North Carolina, United States, 28211
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Durham, North Carolina, United States, 27710
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Raleigh, North Carolina, United States, 27612
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
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Bismarck, North Dakota, United States, 58501
United States, Ohio
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Cincinnati, Ohio, United States, 45219
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
GSK Investigational Site
Cincinnati, Ohio, United States, 45241
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
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Franklin, Ohio, United States, 45005
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Kettering, Ohio, United States, 45429
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Maumee, Ohio, United States, 43537
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Sidney, Ohio, United States, 45322
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
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Feasterville, Pennsylvania, United States, 19053
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Lansdale, Pennsylvania, United States, 19446
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Philadelphia, Pennsylvania, United States, 19115
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Philadelphia, Pennsylvania, United States, 19145
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Reading, Pennsylvania, United States, 19611
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Scranton, Pennsylvania, United States, 18510
United States, Rhode Island
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Cranston, Rhode Island, United States, 02910
GSK Investigational Site
Warick, Rhode Island, United States, 02886
United States, South Carolina
GSK Investigational Site
Summerville, South Carolina, United States, 29485
United States, Tennessee
GSK Investigational Site
Bartlett, Tennessee, United States, 38134
GSK Investigational Site
Bristol, Tennessee, United States, 37620
GSK Investigational Site
Cardova, Tennessee, United States, 38018
United States, Texas
GSK Investigational Site
Arlington, Texas, United States, 76017
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Galveston, Texas, United States, 77555
GSK Investigational Site
Houston, Texas, United States, 77024
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
San Antonio, Texas, United States, 78237
GSK Investigational Site
San Antonio, Texas, United States, 78238
United States, Virginia
GSK Investigational Site
Chesapeake, Virginia, United States, 23320
GSK Investigational Site
Norfolk, Virginia, United States, 23507
United States, Washington
GSK Investigational Site
Federal Way, Washington, United States, 98003
GSK Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Hollander P, Weston WM, Huang C, Chou H, and Porter LE. Low dose rosiglitazone significantly improves glycemic control without increasing adverse events in patients with T2DM not well controlled on insulin. Diabetes 2005;54(suppl 1):A3-4. Abstract 12-OR.

Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 49653/347
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 49653/347
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: 49653/347
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: 49653/347
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: 49653/347
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: 49653/347
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00329225     History of Changes
Obsolete Identifiers: NCT00054782
Other Study ID Numbers: 49653/347 
Study First Received: May 22, 2006
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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 Mellitus Thiazolidinediones Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Rosiglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016