Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
This study has been completed.
Information provided by (Responsible Party):
First received: May 22, 2006
Last updated: April 11, 2013
Last verified: November 2012
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- HbA1c at each visit [ Time Frame: 28 Weeks ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2004 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00329225
|GSK Investigational Site
|Winston-Salem, North Carolina, United States, 27103 |
||GSK Clinical Trials
Hollander P, Weston WM, Huang C, Chou H, and Porter LE. Low dose rosiglitazone significantly improves glycemic control without increasing adverse events in patients with T2DM not well controlled on insulin. Diabetes 2005;54(suppl 1):A3-4. Abstract 12-OR.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 22, 2006
||April 11, 2013
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Type 2 Diabetes Mellitus Thiazolidinediones Insulin
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Physiological Effects of Drugs