Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00329225
First received: May 22, 2006
Last updated: April 11, 2013
Last verified: November 2012
  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
Diabetes Mellitus
Drug: rosiglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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)
Intervention Details:
    Drug: rosiglitazone
    Other Name: rosiglitazone
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, North Carolina
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00329225     History of Changes
Obsolete Identifiers: NCT00054782
Other Study ID Numbers: 49653/347
Study First Received: May 22, 2006
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Type 2 Diabetes Mellitus Thiazolidinediones Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014