Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 Diabetes Mellitus Thiazolidinediones Insulin
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.
Interventions
DRUGrosiglitazone
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c at each visit | 28 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed