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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329225
• Other study ID #: 49653/347
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2006
• Last updated: September 13, 2016
• Start date: September 2002
• Est. completion date: April 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Other known NCT identifiers

• NCT00054782

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• rosiglitazone

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Unknown
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bartlett	Tennessee
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Bismarck	North Dakota
United States	GSK Investigational Site	Blue Ridge	Georgia
United States	GSK Investigational Site	Boynton Beach	Florida
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Butte	Montana
United States	GSK Investigational Site	Cadillac	Michigan
United States	GSK Investigational Site	Cardova	Tennessee
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Centennial	Colorado
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chesapeake	Virginia
United States	GSK Investigational Site	Chesterfield	Missouri
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Concord	California
United States	GSK Investigational Site	Cooperstown	New York
United States	GSK Investigational Site	Cranston	Rhode Island
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Deland	Florida
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fairfield	Alabama
United States	GSK Investigational Site	Feasterville	Pennsylvania
United States	GSK Investigational Site	Federal Way	Washington
United States	GSK Investigational Site	Fort Meyers	Florida
United States	GSK Investigational Site	Franklin	Ohio
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Fulton	New York
United States	GSK Investigational Site	Fultondale	Alabama
United States	GSK Investigational Site	Galveston	Texas
United States	GSK Investigational Site	Garden Grove	California
United States	GSK Investigational Site	Gurnee	Illinois
United States	GSK Investigational Site	Hamden	Connecticut
United States	GSK Investigational Site	Haverhill	Massachusetts
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Hillsborough	New Jersey
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Idaho Falls	Idaho
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Johnson City	New York
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Kenilworth	New Jersey
United States	GSK Investigational Site	Kettering	Ohio
United States	GSK Investigational Site	La Jolla	California
United States	GSK Investigational Site	Lake Charles	Louisiana
United States	GSK Investigational Site	Lansdale	Pennsylvania
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Longmont	Colorado
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madison	Kentucky
United States	GSK Investigational Site	Marrero	Louisiana
United States	GSK Investigational Site	Martinsville	New Jersey
United States	GSK Investigational Site	Maumee	Ohio
United States	GSK Investigational Site	Melrose Park	Illinois
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Montgomery	Alabama
United States	GSK Investigational Site	New Hyde Park	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Ocala	Florida
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orland Park	Illinois
United States	GSK Investigational Site	Pahrump	Nevada
United States	GSK Investigational Site	Pasadena	California
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Picayune	Mississippi
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Reading	Pennsylvania
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Scranton	Pennsylvania
United States	GSK Investigational Site	Sidney	Ohio
United States	GSK Investigational Site	Silver Spring	Maryland
United States	GSK Investigational Site	Slidell	Louisiana
United States	GSK Investigational Site	Slidell	Louisiana
United States	GSK Investigational Site	South Bend	Indiana
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	Springfield	Illinois
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Staten Island	New York
United States	GSK Investigational Site	Summerville	South Carolina
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Taunton	Massachusetts
United States	GSK Investigational Site	Troy	Michigan
United States	GSK Investigational Site	Vernon Hills	Illinois
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Warick	Rhode Island
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	West Hills	California
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Spain, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c at each visit		28 Weeks
Secondary	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

External 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.