Last updated: 11/04/2018 03:27:38

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

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GSK study ID
49653/347
See study documents
Clinicaltrials.gov ID
NCT00329225
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

HbA1c at each visit

Timeframe: 28 Weeks

Secondary outcomes:

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

Timeframe: 28 Weeks

Interventions:
  • Drug: rosiglitazone
    • Enrollment:
    630
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical 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.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    September 2002 to April 2004
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • 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.
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

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    Terminated/Withdrawn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    Terminated/Withdrawn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    Terminated/Withdrawn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    Terminated/Withdrawn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

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-27-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

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