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Diabetes Mellitus, Type 2Phase 4NCT00329225

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

A Phase 4 study testing rosiglitazone in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 131 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
rosiglitazone
How many people
630 participants
Where
131 sitesin 2 countries
Study dates
Sep 2002to Apr 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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 locations and contacts

131 sites in 2 countries.

131 sites in 2 countries

United States130 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Arlington, Texas, 76017

  • GSK Investigational Site

    Atlanta, Georgia, 30328

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Augusta, Georgia, 30904

  • GSK Investigational Site

    Baltimore, Maryland, 21204

  • GSK Investigational Site

    Bartlett, Tennessee, 38134

  • GSK Investigational Site

    Birmingham, Alabama, 35205

  • GSK Investigational Site

    Birmingham, Alabama, 35234

  • GSK Investigational Site

    Bismarck, North Dakota, 58501

  • GSK Investigational Site

    Blue Ridge, Georgia, 30513

  • GSK Investigational Site

    Boynton Beach, Florida, 33437

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Brooklyn, New York, 11216

  • GSK Investigational Site

    Buffalo, New York, 14209

  • GSK Investigational Site

    Butte, Montana, 59701

  • GSK Investigational Site

    Cadillac, Michigan, 49601

  • GSK Investigational Site

    Cardova, Tennessee, 38018

  • GSK Investigational Site

    Cary, North Carolina, 27511

  • GSK Investigational Site

    Centennial, Colorado, 80112

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Charlotte, North Carolina, 28211

  • GSK Investigational Site

    Chesapeake, Virginia, 23320

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • GSK Investigational Site

    Chicago, Illinois, 60607

  • GSK Investigational Site

    Chicago, Illinois, 60610

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cincinnati, Ohio, 45224

  • GSK Investigational Site

    Cincinnati, Ohio, 45241

  • GSK Investigational Site

    Cincinnati, Ohio, 45242

  • GSK Investigational Site

    Concord, California, 94520

  • GSK Investigational Site

    Cooperstown, New York, 13326

  • GSK Investigational Site

    Cranston, Rhode Island, 02910

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Denver, Colorado, 80209

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fairfield, Alabama, 35064

  • GSK Investigational Site

    Feasterville, Pennsylvania, 19053

  • GSK Investigational Site

    Federal Way, Washington, 98003

  • GSK Investigational Site

    Fort Meyers, Florida, 33907

  • GSK Investigational Site

    Franklin, Ohio, 45005

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Fulton, New York, 13009

  • GSK Investigational Site

    Fultondale, Alabama, 35068

  • GSK Investigational Site

    Galveston, Texas, 77555

  • GSK Investigational Site

    Garden Grove, California, 92840

  • GSK Investigational Site

    Gurnee, Illinois, 60031

  • GSK Investigational Site

    Hamden, Connecticut, 06518

  • GSK Investigational Site

    Haverhill, Massachusetts, 01831-2451

  • GSK Investigational Site

    Henderson, Nevada, 89014

  • GSK Investigational Site

    Hillsborough, New Jersey, 08844

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Honolulu, Hawaii, 96813

  • GSK Investigational Site

    Honolulu, Hawaii, 96814

  • GSK Investigational Site

    Houston, Texas, 77024

  • GSK Investigational Site

    Idaho Falls, Idaho, 83404

  • GSK Investigational Site

    Indianapolis, Indiana, 46250

  • GSK Investigational Site

    Jacksonville, Florida, 32204

  • GSK Investigational Site

    Johnson City, New York, 13790

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Kenilworth, New Jersey, 07033

  • GSK Investigational Site

    Kettering, Ohio, 45429

  • GSK Investigational Site

    La Jolla, California, 92037

  • GSK Investigational Site

    Lake Charles, Louisiana, 70601

  • GSK Investigational Site

    Lansdale, Pennsylvania, 19446

  • GSK Investigational Site

    Las Vegas, Nevada, 89104

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Longmont, Colorado, 80501

  • GSK Investigational Site

    Los Angeles, California, 90059

  • GSK Investigational Site

    Madison, Kentucky, 42431

  • GSK Investigational Site

    Marrero, Louisiana, 70072

  • GSK Investigational Site

    Martinsville, New Jersey, 08836

  • GSK Investigational Site

    Maumee, Ohio, 43537

  • GSK Investigational Site

    Melrose Park, Illinois, 60160

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53209-0996

  • GSK Investigational Site

    Montgomery, Alabama, 36106

  • GSK Investigational Site

    New Hyde Park, New York, 11042

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    New York, New York, 10024

  • GSK Investigational Site

    Norfolk, Virginia, 23507

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Orland Park, Illinois, 60462

  • GSK Investigational Site

    Pahrump, Nevada, 89048

  • GSK Investigational Site

    Pasadena, California, 91105

  • GSK Investigational Site

    Pembroke Pines, Florida, 33024

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19115

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19145

  • GSK Investigational Site

    Phoenix, Arizona, 85016

  • GSK Investigational Site

    Phoenix, Arizona, 85029

  • GSK Investigational Site

    Picayune, Mississippi, 39466

  • GSK Investigational Site

    Raleigh, North Carolina, 27612

  • GSK Investigational Site

    Reading, Pennsylvania, 19611

  • GSK Investigational Site

    Sacramento, California, 95825

  • GSK Investigational Site

    Sacramento, California, 95841

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78237

  • GSK Investigational Site

    San Antonio, Texas, 78238

  • GSK Investigational Site

    Sarasota, Florida, 34239

  • GSK Investigational Site

    Scranton, Pennsylvania, 18510

  • GSK Investigational Site

    Sidney, Ohio, 45322

  • GSK Investigational Site

    Silver Spring, Maryland, 20910

  • GSK Investigational Site

    Slidell, Louisiana, 70458

  • GSK Investigational Site

    Slidell, Louisiana, 70461

  • GSK Investigational Site

    South Bend, Indiana, 46601

  • GSK Investigational Site

    Springfield, Illinois, 62704

  • GSK Investigational Site

    Springfield, Missouri, 65807

  • GSK Investigational Site

    St Louis, Missouri, 63108

  • GSK Investigational Site

    Staten Island, New York, 10301

  • GSK Investigational Site

    Summerville, South Carolina, 29485

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Taunton, Massachusetts, 02780

  • GSK Investigational Site

    Troy, Michigan, 48098

  • GSK Investigational Site

    Vernon Hills, Illinois, 60061

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    Warick, Rhode Island, 02886

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010

  • GSK Investigational Site

    West Hills, California, 91307

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    Wichita, Kansas, 67203

  • GSK Investigational Site

    Wichita, Kansas, 67208

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Location not given1 site

  • GSK Investigational Site

About this study

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

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.

Being tested
rosiglitazone
Keywords
Type 2 Diabetes Mellitus Thiazolidinediones Insulin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rosiglitazoneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c at each visit

    Measured: 28 Weeks

Secondary outcomes (1)

  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

    Measured: 28 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2006 (estimated)
  2. Study startSep 2002
  3. Primary completionApr 2004
  4. Study completionApr 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00329225
Sponsor's protocol ID
49653/347
Status last verified
Sep 2016
First submitted
22 May 2006
Last updated
15 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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.

  • 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.

    PubMed 17592102

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rosiglitazone in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 131 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c at each visit (time frame: 28 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00329225, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.

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