Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
NCT ID: NCT00329225
Last Updated: 2016-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
630 participants
INTERVENTIONAL
2002-09-30
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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rosiglitazone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Fairfield, Alabama, United States
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Fultondale, Alabama, United States
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Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Jonesboro, Arkansas, United States
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Concord, California, United States
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Fresno, California, United States
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Garden Grove, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Pasadena, California, United States
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Sacramento, California, United States
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Sacramento, California, United States
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Walnut Creek, California, United States
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West Hills, California, United States
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Centennial, Colorado, United States
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Denver, Colorado, United States
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Longmont, Colorado, United States
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Hamden, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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DeLand, Florida, United States
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Fort Meyers, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Pembroke Pines, Florida, United States
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Sarasota, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Blue Ridge, Georgia, United States
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Honolulu, Hawaii, United States
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Honolulu, Hawaii, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Melrose Park, Illinois, United States
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Orland Park, Illinois, United States
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Springfield, Illinois, United States
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Vernon Hills, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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South Bend, Indiana, United States
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Wichita, Kansas, United States
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Wichita, Kansas, United States
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Madison, Kentucky, United States
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Lake Charles, Louisiana, United States
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Marrero, Louisiana, United States
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Slidell, Louisiana, United States
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Slidell, Louisiana, United States
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Baltimore, Maryland, United States
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Silver Spring, Maryland, United States
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Haverhill, Massachusetts, United States
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Taunton, Massachusetts, United States
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Cadillac, Michigan, United States
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Troy, Michigan, United States
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Picayune, Mississippi, United States
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Chesterfield, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Hillsborough, New Jersey, United States
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Kenilworth, New Jersey, United States
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Martinsville, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Cooperstown, New York, United States
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Fulton, New York, United States
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Johnson City, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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New York, New York, United States
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Staten Island, New York, United States
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Franklin, Ohio, United States
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Kettering, Ohio, United States
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Maumee, Ohio, United States
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Sidney, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Feasterville, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Scranton, Pennsylvania, United States
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Cranston, Rhode Island, United States
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Warick, Rhode Island, United States
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Summerville, South Carolina, United States
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Bartlett, Tennessee, United States
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Bristol, Tennessee, United States
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Cardova, Tennessee, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Chesapeake, Virginia, United States
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Norfolk, Virginia, United States
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Federal Way, Washington, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Countries
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References
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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.
Hollander P, Yu D, Chou HS. Low-dose rosiglitazone in patients with insulin-requiring type 2 diabetes. Arch Intern Med. 2007 Jun 25;167(12):1284-90. doi: 10.1001/archinte.167.12.1284.
Study Documents
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Document Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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49653/347
Identifier Type: -
Identifier Source: org_study_id
NCT00054782
Identifier Type: -
Identifier Source: nct_alias
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