Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
Launched by GLAXOSMITHKLINE · May 22, 2006
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility 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.
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
New York, New York, United States
San Antonio, Texas, United States
Washington, District Of Columbia, United States
Dallas, Texas, United States
Idaho Falls, Idaho, United States
Tacoma, Washington, United States
Jonesboro, Arkansas, United States
Norfolk, Virginia, United States
Charlotte, North Carolina, United States
Sacramento, California, United States
Hillsborough, New Jersey, United States
Durham, North Carolina, United States
Fresno, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Walnut Creek, California, United States
Longmont, Colorado, United States
Ocala, Florida, United States
Honolulu, Hawaii, United States
Melrose Park, Illinois, United States
Evansville, Indiana, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Cary, North Carolina, United States
Raleigh, North Carolina, United States
Winston Salem, North Carolina, United States
Bismarck, North Dakota, United States
Cincinnati, Ohio, United States
Kettering, Ohio, United States
Arlington, Texas, United States
Houston, Texas, United States
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Galveston, Texas, United States
Boynton Beach, Florida, United States
Albuquerque, New Mexico, United States
Kenilworth, New Jersey, United States
Phoenix, Arizona, United States
Concord, California, United States
Pasadena, California, United States
Fort Meyers, Florida, United States
Hollywood, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
Baltimore, Maryland, United States
Haverhill, Massachusetts, United States
Buffalo, New York, United States
Summerville, South Carolina, United States
Bristol, Tennessee, United States
Hamden, Connecticut, United States
Lake Charles, Louisiana, United States
Philadelphia, Pennsylvania, United States
Garden Grove, California, United States
Centennial, Colorado, United States
Deland, Florida, United States
Atlanta, Georgia, United States
Blue Ridge, Georgia, United States
Wichita, Kansas, United States
Silver Spring, Maryland, United States
Chesterfield, Missouri, United States
Feasterville, Pennsylvania, United States
Reading, Pennsylvania, United States
Chesapeake, Virginia, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
Milwaukee, Wisconsin, United States
Orland Park, Illinois, United States
Vernon Hills, Illinois, United States
Oklahoma City, Oklahoma, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
La Jolla, California, United States
West Palm Beach, Florida, United States
New Hyde Park, New York, United States
Slidell, Louisiana, United States
Butte, Montana, United States
Picayune, Mississippi, United States
Birmingham, Alabama, United States
Montgomery, Alabama, United States
Denver, Colorado, United States
Cadillac, Michigan, United States
Las Vegas, Nevada, United States
Pahrump, Nevada, United States
Johnson City, New York, United States
Springfield, Illinois, United States
Taunton, Massachusetts, United States
West Hills, California, United States
Franklin, Ohio, United States
Troy, Michigan, United States
St. Louis, Missouri, United States
Maumee, Ohio, United States
Gurnee, Illinois, United States
Federal Way, Washington, United States
Fairfield, Alabama, United States
Fultondale, Alabama, United States
Augusta, Georgia, United States
Madison, Kentucky, United States
Marrero, Louisiana, United States
Martinsville, New Jersey, United States
Brooklyn, New York, United States
Cooperstown, New York, United States
Fulton, New York, United States
Staten Island, New York, United States
Sidney, Ohio, United States
Lansdale, Pennsylvania, United States
Scranton, Pennsylvania, United States
Cranston, Rhode Island, United States
Warick, Rhode Island, United States
Bartlett, Tennessee, United States
Cardova, Tennessee, United States
Patients applied
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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