Status:
COMPLETED
Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00329225
Start Date
September 1 2002
End Date
April 1 2004
Last Update
September 15 2016
Active Locations (131)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35205
2
GSK Investigational Site
Birmingham, Alabama, United States, 35234
3
GSK Investigational Site
Fairfield, Alabama, United States, 35064
4
GSK Investigational Site
Fultondale, Alabama, United States, 35068