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

Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus

Intervention: rosiglitazone (Drug)

Phase: Phase 3

Status: No longer recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, PhD, Study Director, Affiliation: GlaxoSmithKline

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.

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: HbA1c at each visit

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

GSK Clinical Trials Center, Montgomery, Alabama 36106, United States

GSK Clinical Trials Center, Birmingham, Alabama 35234, United States

GSK Clinical Trials Center, Birmingham, Alabama 35234, United States

GSK Clinical Trials Center, Phoenix, Arizona 85016, United States

GSK Clinical Trials Center, Phoenix, Arizona 85029, United States

GSK Clinical Trials Center, Pasadena, California 91105, United States

GSK Clinical Trials Center, Alhambra, California 91801, United States

GSK Clinical Trials Center, Carmichael, California 95608, United States

GSK Clinical Trials Center, Concord, California 94520, United States

GSK Clinical Trials Center, Fresno, California 93720, United States

GSK Clinical Trials Center, West Hills, California 91307, United States

GSK Clinical Trials Center, Walnut Creek, California 94598, United States

GSK Clinical Trials Center, Los Angeles, California 85712, United States

GSK Clinical Trials Center, Sacramento, California 95841, United States

GSK Clinical Trials Center, Sacramento, California 95825, United States

GSK Clinical Trials Center, LaJolla, California 92037, United States

GSK Clinical Trials Center, Garden Grove, California 92840, United States

GSK Clinical Trials Center, Long Beach, California 90806, United States

GSK Clinical Trials Center, Hamden, Connecticut 06518, United States

GSK Clinical Trials Center, Gainesville, Florida 32610, United States

GSK Clinical Trials Center, West Palm Beach, Florida 33401, United States

GSK Clinical Trials Center, Hollywood, Florida 33021, United States

GSK Clinical Trials Call Center, Miami, Florida 33145, United States

GSK Clinical Trials Center, Ocala, Florida 34471, United States

GSK Clinical Trials Center, Miami, Florida 33156, United States

GSK Clinical Trials Center, Pembroke Pines, Florida 33024, United States

GSK Clinical Trials Center, Altamonte Springs, Florida 32714, United States

GSK Clinical Trials Center, Boynton Beach, Florida 33437, United States

GSK Clinical Trials Center, Miami, Florida 33176, United States

GSK Clinical Trials Center, Fort Myers, Florida 33907, United States

GSK Clinical Trials Call Center, Sarasota, Florida 34239, United States

GSK Clinical Trials Center, Jacksonville, Florida 32204, United States

GSK Clinical Trials Center, Atlanta, Georgia 30328, United States

GSK Clinical Trials Center, Blue Ridge, Georgia 30513, United States

GSK Clinical Trials Center, Augusta, Georgia 30904, United States

GSK Clinical Trials Center, Honolulu, Hawaii 96813, United States

GSK Clinical Trials Center, Honolulu, Hawaii 96814, United States

GSK Clinical Trials Center, Idaho Falls, Idaho 83404, United States

GSK Clinical Trials Center, Vernon Hills, Illinois 60061, United States

GSK Clinical Trials Center, Melrose Park, Illinois 60160, United States

GSK Clinical Trials Center, Orland Park, Illinois 60462, United States

GSK Clinical Trials Center, Chicago, Illinois 60610, United States

GSK Clinical Trials Center, Peoria, Illinois 61602, United States

GSK Clinical Trials Center, Gurnee, Illinois 60031, United States

GSK Clinical Trials Center, Springfield, Illinois 62704, United States

GSK Clinical Trials Center, Chicago, Illinois 60607, United States

GSK Clinical Trials Center, Evansville, Indiana 47714, United States

GSK Clinical Trials Center, South Bend, Indiana 46601, United States

GSK Clinical Trials Center, Indianapolis, Indiana 46250, United States

GSK Clinical Trials Center, Wichita, Kansas 67208, United States

GSK Clinical Trials Center, Wichita, Kansas 67203, United States

GSK Clinical Trials Center, Madisonville, Kentucky 42431, United States

GSK Clinical Trials Center, Slidell, Louisiana 70458, United States

GSK Clinical Trials Center, Lake Charles, Louisiana 70601, United States

GSK Clinical Trials Center, Marrero, Louisiana 70072, United States

GSK Clinical Trials Center, Slidell, Louisiana 70458, United States

GSK Clinical Trials Center, Salisbury, Maryland 01952, United States

GSK Clinical Trials Center, Baltimore, Maryland 21204, United States

GSK Clinical Trials Center, Taunton, Massachusetts 02780, United States

GSK Clinical Trials Center, Salisbury, Massachusetts 01952, United States

GSK Clinical Trials Center, Cadillac, Michigan 49601, United States

GSK Clinical Trials Center, Picayune, Mississippi 39466, United States

GSK Clinical Trials Center, Springfield, Missouri 65807, United States

GSK Clinical Trials Center, St. Louis, Missouri 63108, United States

GSK Clinical Trials Center, Chesterfield, Missouri 63017, United States

GSK Clinical Trials Center, Butte, Montana 59701, United States

GSK Clinical Trials Center, Omaha, Nebraska 68131, United States

GSK Clinical Trials Center, Grand Island, Nebraska 68803, United States

GSK Clinical Trials Center, Las Vegas, Nevada 89119, United States

GSK Clinical Trials Center, Pahrump, Nevada 89048, United States

GSK Clinical Trials Center, Las Vegas, Nevada 89128, United States

GSK Clinical Trials Center, Perth Amboy, New Jersey 08861, United States

GSK Clinical Trials Center, Kenilworth, New Jersey 07033, United States

GSK Clinical Trials Center, Hillsborough, New Jersey 08844, United States

GSK Clinical Trials Center, Martinsville, New Jersey 08836, United States

GSK Clinical Trials Center, Albuquerque, New Mexico 87108, United States

GSK Clinical Trials Center, Cooperstown, New York 13326, United States

GSK Clinical Trials Center, Fulton, New York 13069, United States

GSK Clinical Trials Center, Brooklyn, New York 11216, United States

GSK Clinical Trials Center, New York, New York 10024, United States

GSK Clinical Trials Center, Staten Island, New York 10301, United States

GSK Clinical Trials Center, New York, New York 10016, United States

GSK Clinical Trials Center, New Hyde Park, New York 11042, United States

GSK Clinical Trials Center, New York, New York 10029, United States

GSK Clinical Trials Center, Binghamton, New York 13901, United States

GSK Clinical Trials Center, Winston Salem, North Carolina 27157-1084, United States

GSK Clinical Trials Center, Winston Salem, North Carolina 27103, United States

GSK Clinical Trials Center, Charlotte, North Carolina 28209, United States

GSK Clinical Trials Center, Charlotte, North Carolina 28211, United States

GSK Clinical Trials Center, Raleigh, North Carolina 27612, United States

GSK Clinical Trials Center, Durham, North Carolina 27710, United States

GSK Clinical Trials Center, Bismarck, North Dakota 58501, United States

GSK Clinical Trials Center, Genoa, Ohio 43430, United States

GSK Clinical Trials Center, Kettering, Ohio 45429, United States

GSK Clinical Trials Center, Englewood, Ohio 45005, United States

GSK Clinical Trials Center, Cincinnati, Ohio 45241, United States

GSK Clinical Trials Center, Huber Heights, Ohio 45424, United States

GSK Clinical Trials Center, Oklahoma City, Oklahoma 73103, United States

GSK Clinical Trials Center, Scranton, Pennsylvania 18510, United States

GSK Clinical Trials Center, Feasterville Trevose, Pennsylvania 19053, United States

GSK Clinical Trials Center, Temple, Pennsylvania 19560, United States

GSK Clinical Trials Center, Lansdale, Pennsylvania 19446, United States

GSK Clinical Trials Center, Philadelphia, Pennsylvania 19115, United States

GSK Clinical Trials Center, Cranston, Rhode Island 02920, United States

GSK Clinical Trials Center, Cranston, Rhode Island 02920, United States

GSK Clinical Trials Center, Warwick, Rhode Island 02886, United States

GSK Clinical Trials Center, Summerville, South Carolina 29485, United States

GSK Clinical Trials Center, Bartlett, Tennessee 38134, United States

GSK Clinical Trials Center, Houston, Texas 77024, United States

GSK Clinical Trials Center, Dallas, Texas 75246, United States

GSK Clinical Trials Center, Dallas, Texas 75230, United States

GSK Clinical Trials Center, San Antonio, Texas 78237, United States

GSK Clinical Trials Center, Arlington, Texas 76017, United States

GSK Clinical Trials Center, San Antonio, Texas 78229, United States

GSK Clinical Trials Center, Galveston, Texas 77555-1123, United States

GSK Clinical Trials Center, Chesapeake, Virginia 23321, United States

GSK Clinical Trials Center, Norfolk, Virginia 23507, United States

GSK Clinical Trials Center, Fredericksburg, Virginia 22408, United States

GSK Clinical Trials Center, Federal Way, Washington 98003, United States

GSK Clinical Trials Center, Milwaukee, Wisconsin 53209-0996, United States

Starting date: November 2002
Last updated: May 22, 2006