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Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00329225
  Purpose

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.


Condition Intervention Phase
Non-Insulin-Dependent Diabetes Mellitus
Drug: rosiglitazone
Phase IV

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by GlaxoSmithKline:

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: 630
Study Start Date: September 2002
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329225

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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
  More Information

Publications indexed to this study:
Responsible Party: GSK ( Study Director )
Study ID Numbers: 49653/347
Study First Received: May 22, 2006
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00329225  
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Type 2 Diabetes Mellitus Thiazolidinediones Insulin

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
2,4-thiazolidinedione
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009