Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
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
1 other identifier
interventional
630
1 country
130
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Sep 2002
130 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 22, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedSeptember 15, 2016
September 1, 2016
1.6 years
May 22, 2006
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c at each visit
28 Weeks
Secondary Outcomes (1)
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
28 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (131)
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Birmingham, Alabama, 35234, United States
GSK Investigational Site
Fairfield, Alabama, 35064, United States
GSK Investigational Site
Fultondale, Alabama, 35068, United States
GSK Investigational Site
Montgomery, Alabama, 36106, United States
GSK Investigational Site
Phoenix, Arizona, 85016, United States
GSK Investigational Site
Phoenix, Arizona, 85029, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Concord, California, 94520, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Garden Grove, California, 92840, United States
GSK Investigational Site
La Jolla, California, 92037, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Los Angeles, California, 90059, United States
GSK Investigational Site
Pasadena, California, 91105, United States
GSK Investigational Site
Sacramento, California, 95825, United States
GSK Investigational Site
Sacramento, California, 95841, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
West Hills, California, 91307, United States
GSK Investigational Site
Centennial, Colorado, 80112, United States
GSK Investigational Site
Denver, Colorado, 80209, United States
GSK Investigational Site
Longmont, Colorado, 80501, United States
GSK Investigational Site
Hamden, Connecticut, 06518, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20010, United States
GSK Investigational Site
Boynton Beach, Florida, 33437, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Fort Meyers, Florida, 33907, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
Jacksonville, Florida, 32204, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Pembroke Pines, Florida, 33024, United States
GSK Investigational Site
Sarasota, Florida, 34239, United States
GSK Investigational Site
West Palm Beach, Florida, 33401, United States
GSK Investigational Site
Atlanta, Georgia, 30328, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Augusta, Georgia, 30904, United States
GSK Investigational Site
Blue Ridge, Georgia, 30513, United States
GSK Investigational Site
Honolulu, Hawaii, 96813, United States
GSK Investigational Site
Honolulu, Hawaii, 96814, United States
GSK Investigational Site
Idaho Falls, Idaho, 83404, United States
GSK Investigational Site
Chicago, Illinois, 60607, United States
GSK Investigational Site
Chicago, Illinois, 60610, United States
GSK Investigational Site
Gurnee, Illinois, 60031, United States
GSK Investigational Site
Melrose Park, Illinois, 60160, United States
GSK Investigational Site
Orland Park, Illinois, 60462, United States
GSK Investigational Site
Springfield, Illinois, 62704, United States
GSK Investigational Site
Vernon Hills, Illinois, 60061, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Indianapolis, Indiana, 46250, United States
GSK Investigational Site
South Bend, Indiana, 46601, United States
GSK Investigational Site
Wichita, Kansas, 67203, United States
GSK Investigational Site
Wichita, Kansas, 67208, United States
GSK Investigational Site
Madison, Kentucky, 42431, United States
GSK Investigational Site
Lake Charles, Louisiana, 70601, United States
GSK Investigational Site
Marrero, Louisiana, 70072, United States
GSK Investigational Site
Slidell, Louisiana, 70458, United States
GSK Investigational Site
Slidell, Louisiana, 70461, United States
GSK Investigational Site
Baltimore, Maryland, 21204, United States
GSK Investigational Site
Silver Spring, Maryland, 20910, United States
GSK Investigational Site
Haverhill, Massachusetts, 01831-2451, United States
GSK Investigational Site
Taunton, Massachusetts, 02780, United States
GSK Investigational Site
Cadillac, Michigan, 49601, United States
GSK Investigational Site
Troy, Michigan, 48098, United States
GSK Investigational Site
Picayune, Mississippi, 39466, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
St Louis, Missouri, 63108, United States
GSK Investigational Site
Butte, Montana, 59701, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Henderson, Nevada, 89014, United States
GSK Investigational Site
Las Vegas, Nevada, 89104, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Pahrump, Nevada, 89048, United States
GSK Investigational Site
Hillsborough, New Jersey, 08844, United States
GSK Investigational Site
Kenilworth, New Jersey, 07033, United States
GSK Investigational Site
Martinsville, New Jersey, 08836, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Brooklyn, New York, 11216, United States
GSK Investigational Site
Buffalo, New York, 14209, United States
GSK Investigational Site
Cooperstown, New York, 13326, United States
GSK Investigational Site
Fulton, New York, 13009, United States
GSK Investigational Site
Johnson City, New York, 13790, United States
GSK Investigational Site
New Hyde Park, New York, 11042, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10024, United States
GSK Investigational Site
Staten Island, New York, 10301, United States
GSK Investigational Site
Cary, North Carolina, 27511, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Charlotte, North Carolina, 28211, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Raleigh, North Carolina, 27612, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27157, United States
GSK Investigational Site
Bismarck, North Dakota, 58501, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Cincinnati, Ohio, 45224, United States
GSK Investigational Site
Cincinnati, Ohio, 45241, United States
GSK Investigational Site
Cincinnati, Ohio, 45242, United States
GSK Investigational Site
Franklin, Ohio, 45005, United States
GSK Investigational Site
Kettering, Ohio, 45429, United States
GSK Investigational Site
Maumee, Ohio, 43537, United States
GSK Investigational Site
Sidney, Ohio, 45322, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Feasterville, Pennsylvania, 19053, United States
GSK Investigational Site
Lansdale, Pennsylvania, 19446, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19115, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19145, United States
GSK Investigational Site
Reading, Pennsylvania, 19611, United States
GSK Investigational Site
Scranton, Pennsylvania, 18510, United States
GSK Investigational Site
Cranston, Rhode Island, 02910, United States
GSK Investigational Site
Warick, Rhode Island, 02886, United States
GSK Investigational Site
Summerville, South Carolina, 29485, United States
GSK Investigational Site
Bartlett, Tennessee, 38134, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Cardova, Tennessee, 38018, United States
GSK Investigational Site
Arlington, Texas, 76017, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Galveston, Texas, 77555, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78237, United States
GSK Investigational Site
San Antonio, Texas, 78238, United States
GSK Investigational Site
Chesapeake, Virginia, 23320, United States
GSK Investigational Site
Norfolk, Virginia, 23507, United States
GSK Investigational Site
Federal Way, Washington, 98003, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53209-0996, United States
GSK Investigational Site
Related Publications (2)
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.
RESULTHollander 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.
PMID: 17592102DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2006
First Posted
May 24, 2006
Study Start
September 1, 2002
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.