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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: rosiglitazone

• Study Type: Interventional
• Enrollment (Actual): 630
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c at each visit	28 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): April 1, 2004
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: May 22, 2006
• First Submitted That Met QC Criteria: May 22, 2006
• First Posted (Estimate): May 24, 2006

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus Thiazolidinediones Insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Rosiglitazone
• Other Study ID Numbers: 49653/347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Dataset Specification
   Information identifier: 49653/347
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 49653/347
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 49653/347
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 49653/347
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: 49653/347
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: 49653/347
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register