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AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

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AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin.

NCT00241605•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
•Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
•Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.

Exclusion Criteria

•Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
•Have a known hypersensitivity to thiazolidinediones or biguanides.
•Currently using insulin or any oral anti-diabetic agent other than metformin.
•History of metabolic acidosis.
•History of substance abuse.
•Have active cancer other than localized squamous or basal cell carcinoma.
•Chronic disease requiring treatment with corticosteroids.
•Other criteria will be evaluated at the screening visit.

Locations (91)

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Medicine Hat, Alberta, Canada

Key Dates

Start Date

June 25, 2003

Primary Completion Date

December 1, 2005

Completion Date

December 16, 2005

Last Updated

March 21, 2018

Enrollment

600

Estimated participants

Conditions

Diabetes Mellitus, Type 2

Interventions

rosiglitazone/metformin

DRUG

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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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AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

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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