Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
