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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: rosiglitazone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00329225

49653/347

Details and patient eligibility

About

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.

Enrollment

630 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.