Clinical trial NCT00329225: Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus Thiazolidinediones Insulin
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: HbA1c at each visit
timeFrame: 28 Weeks
Secondary outcomes:
measure: 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
timeFrame: 28 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Fairfield
country: United States
facility: GSK Investigational Site
state: Alabama
city: Fultondale
country: United States
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state: Alabama
city: Montgomery
country: United States
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state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Concord
country: United States
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state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Garden Grove
country: United States
facility: GSK Investigational Site
state: California
city: La Jolla
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state: California
city: Long Beach
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state: California
city: Los Angeles
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state: California
city: Pasadena
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state: California
city: Sacramento
country: United States
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state: California
city: Sacramento
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state: California
city: Walnut Creek
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city: West Hills
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state: California
city: Centennial
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state: Colorado
city: Denver
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state: Colorado
city: Longmont
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state: Colorado
city: Hamden
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state: Connecticut
city: Washington
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state: District of Columbia
city: Boynton Beach
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state: Florida
city: Deland
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state: Georgia
city: Atlanta
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city: Chicago
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city: Melrose Park
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city: Omaha
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city: Las Vegas
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facility: GSK Investigational Site
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city: Cincinnati
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city: Sidney
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city: Oklahoma City
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city: Feasterville
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city: Lansdale
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facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
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city: Philadelphia
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city: Reading
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city: Scranton
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city: Cranston
country: United States
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state: Rhode Island
city: Warick
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: Summerville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Bartlett
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Cardova
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Galveston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Chesapeake
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Federal Way
country: United States
facility: GSK Investigational Site
state: Washington
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.