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Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT00329225•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (131)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Fairfield, Alabama, United States

GSK Investigational Site

Fultondale, Alabama, United States

GSK Investigational Site

Montgomery, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Concord, California, United States

GSK Investigational Site

Fresno, California, United States

Key Dates

Start Date

September 1, 2002

Primary Completion Date

April 1, 2004

Completion Date

April 1, 2004

Last Updated

September 15, 2016

Enrollment

630

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

rosiglitazone

DRUG

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RECRUITINGNA

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Diabetes Mellitus, Type 2Depressive Symptoms+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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