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Completed

NCT Number: NCT00241605

AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rosiglitazone/metformin

Drug

Primary outcomes

  1. Change from baseline in HbA1c at week 48.

Secondary outcomes

  1. Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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.

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 19, 2005
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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