| May 22, 2006 |
| October 15, 2008 |
| September 2002 |
| April 2004 (final data collection date for primary outcome measure) |
| HbA1c at each visit [ Time Frame: 28 Weeks ] |
| HbA1c at each visit |
| Complete list of historical versions of study NCT00329225 on ClinicalTrials.gov Archive Site |
| 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 [ Time Frame: 28 Weeks ] |
- 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
|
| |
| Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin |
| 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 |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Non-Insulin-Dependent Diabetes Mellitus |
| Drug: rosiglitazone |
| |
| 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. |
| |
| Completed |
| 630 |
| April 2004 |
| April 2004 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00329225 |
| Study Director, GSK |
| 49653/347 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials, MD, PhD |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| October 2008 |