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Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects | Clinical Trials | Clareo Health

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Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects

A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects

NCT00499707•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 to 70 years of age
•Clinical diagnosis of type 2 diabetes
•HbA1c \>7.5% to 11%
•FPG \<270mg/dL (15mmol)
•Current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening

Exclusion Criteria

•Clinically significant renal or hepatic disease
•Presence of anemia
•Presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
•Systolic blood pressure \>170mmHg or diastolic blood pressure \>100mmHg, while on anti-hypertensive treatment
•Chronic disease requiring intermittent or chronic treatment with corticosteroids
•Any female lactating, pregnant, or planning to become pregnant
•History of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione
•Presence of acute or chronic metabolic acidosis
•History of diabetic ketoacidosis

Locations (102)

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Encinitas, California, United States

GSK Investigational Site

Fullerton, California, United States

GSK Investigational Site

Los Banos, California, United States

GSK Investigational Site

Mission Viejo, California, United States

GSK Investigational Site

Jacksonville, Florida, United States

Key Dates

Start Date

October 8, 2003

Primary Completion Date

December 1, 2004

Completion Date

December 16, 2004

Last Updated

March 21, 2018

Enrollment

453

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

rosiglitazone maleate/metformin hydrochloride

DRUG

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

NCT06959901

Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

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NCT06574035

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: March 21, 2018Data 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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Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects

Inclusion Criteria

Exclusion Criteria

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

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

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)