AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00241605
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : March 21, 2018
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: rosiglitazone/metformin Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : June 25, 2003
Actual Primary Completion Date : December 1, 2005
Actual Study Completion Date : December 16, 2005

Primary Outcome Measures :
  1. Change from baseline in HbA1c at week 48.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00241605

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Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00241605     History of Changes
Other Study ID Numbers: 712753/008
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Keywords provided by GlaxoSmithKline:
Type 2 diabetes

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