AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

March 19, 2018 updated by: GlaxoSmithKline

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1N 1E1
        • GSK Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T3E 7C4
        • GSK Investigational Site
      • Calgary, Alberta, Canada, T1Y 3R6
        • GSK Investigational Site
      • Calgary, Alberta, Canada, T1Y 6J2
        • GSK Investigational Site
      • Calgary, Alberta, Canada, T2A 0P9
        • GSK Investigational Site
      • Calgary, Alberta, Canada, T2L 2V9
        • GSK Investigational Site
      • Calgary, Alberta, Canada, T3B 0M3
        • GSK Investigational Site
      • Calgary, Alberta, Canada, T3E 0C5
        • GSK Investigational Site
      • Edmonton, Alberta, Canada, T5A 4L8
        • GSK Investigational Site
      • Edmonton, Alberta, Canada, T6L 6K3
        • GSK Investigational Site
      • Medicine Hat, Alberta, Canada, T1A 6N9
        • GSK Investigational Site
    • British Columbia
      • Aldergrove, British Columbia, Canada, V4W 3L6
        • GSK Investigational Site
      • Kelowna, British Columbia, Canada, V1Y 3G8
        • GSK Investigational Site
      • Vancouver, British Columbia, Canada, V5P 3T7
        • GSK Investigational Site
      • Vancouver, British Columbia, Canada, V5X 3T5
        • GSK Investigational Site
      • Vancouver, British Columbia, Canada, V7N 4M2
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • GSK Investigational Site
      • Winnipeg, Manitoba, Canada, R2H 0R8
        • GSK Investigational Site
      • Winnipeg, Manitoba, Canada, R2J 4A7
        • GSK Investigational Site
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E5L 1S1
        • GSK Investigational Site
      • Houston, New Brunswick, Canada, E6E 1H1
        • GSK Investigational Site
      • Neguac, New Brunswick, Canada, E9G 4H3
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
        • GSK Investigational Site
      • Carbonear, Newfoundland and Labrador, Canada, A1Y 1C4
        • GSK Investigational Site
      • Saint John's, Newfoundland and Labrador, Canada, A1A 3R5
        • GSK Investigational Site
      • Saint John's, Newfoundland and Labrador, Canada, A1B 2X2
        • GSK Investigational Site
    • Nova Scotia
      • Dartmouth, Nova Scotia, Canada, B2W 2S8
        • GSK Investigational Site
      • Halifax, Nova Scotia, Canada, B3M 3W8
        • GSK Investigational Site
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
      • Upper Tantallon, Nova Scotia, Canada, B3Z 4R4
        • GSK Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 6N2
        • GSK Investigational Site
      • Brampton, Ontario, Canada, L6T 3T1
        • GSK Investigational Site
      • Brampton, Ontario, Canada, L6T 4S5
        • GSK Investigational Site
      • Burlington, Ontario, Canada, L7M 4Y1
        • GSK Investigational Site
      • Cambridge, Ontario, Canada, N3C 1Z3
        • GSK Investigational Site
      • Fort Erie, Ontario, Canada, L2A 1Z3
        • GSK Investigational Site
      • Hamilton, Ontario, Canada, L8L 5G8
        • GSK Investigational Site
      • Innisfil, Ontario, Canada, L9S 1L2
        • GSK Investigational Site
      • Kingston, Ontario, Canada, K7M 1W9
        • GSK Investigational Site
      • London, Ontario, Canada, N6P 1A9
        • GSK Investigational Site
      • London, Ontario, Canada, N5Y 3J8
        • GSK Investigational Site
      • Mississauga, Ontario, Canada, L5B 3A8
        • GSK Investigational Site
      • Mississauga, Ontario, Canada, L5B 4A9
        • GSK Investigational Site
      • North York, Ontario, Canada, M3M 3E5
        • GSK Investigational Site
      • Oakville, Ontario, Canada, L6L 2X4
        • GSK Investigational Site
      • Oshawa, Ontario, Canada, L1H 1C2
        • GSK Investigational Site
      • Ottawa, Ontario, Canada, K2G 6E2
        • GSK Investigational Site
      • Peterborough, Ontario, Canada, K9H 1T6
        • GSK Investigational Site
      • Rexdale, Ontario, Canada, M9V 4B9
        • GSK Investigational Site
      • Richmond Hill, Ontario, Canada, L4C 2N9
        • GSK Investigational Site
      • Scarborough, Ontario, Canada, M1J 2E5
        • GSK Investigational Site
      • Scarborough, Ontario, Canada, M1R 1R9
        • GSK Investigational Site
      • Smiths Falls, Ontario, Canada, K7A 2H6
        • GSK Investigational Site
      • Sutton, Ontario, Canada, L0E 1R0
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 1E2
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M2M 4J5
        • GSK Investigational Site
      • Windsor, Ontario, Canada, B0N 2T0
        • GSK Investigational Site
      • Woodbridge, Ontario, Canada, L4L 8E2
        • GSK Investigational Site
      • Woodstock, Ontario, Canada, E7M 1H1
        • GSK Investigational Site
      • Woodstock, Ontario, Canada, N4S 4H4
        • GSK Investigational Site
    • Quebec
      • Brossard, Quebec, Canada, J4Z 2K9
        • GSK Investigational Site
      • Charlesbourg, Quebec, Canada, G1G 4A2
        • GSK Investigational Site
      • Charlesbourg, Quebec, Canada, G1H 6P2
        • GSK Investigational Site
      • Chateauguay, Quebec, Canada, J6K 3A9
        • GSK Investigational Site
      • Courcelette, Quebec, Canada, G0A 1R1
        • GSK Investigational Site
      • Cowansville, Quebec, Canada, J2K 2X9
        • GSK Investigational Site
      • Hull, Quebec, Canada, J8Y 2E2
        • GSK Investigational Site
      • Lambton, Quebec, Canada, G0M 1H0
        • GSK Investigational Site
      • Lle Perrot, Quebec, Canada, H8Y 3J2
        • GSK Investigational Site
      • Longueuil, Quebec, Canada, J4J 3X5
        • GSK Investigational Site
      • Longueuil, Quebec, Canada, J4N 1E1
        • GSK Investigational Site
      • Longueuil, Quebec, Canada, J4N 1L6
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H4N 2W2
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H1M 2M1
        • GSK Investigational Site
      • Pierrefonds, Quebec, Canada, H8Y 3J2
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • GSK Investigational Site
      • Richelieu, Quebec, Canada, J3L 4W6
        • GSK Investigational Site
      • Saint Charles Borromee, Quebec, Canada, J6E 5A9
        • GSK Investigational Site
      • Saint Leonard, Quebec, Canada, H1S 3A9
        • GSK Investigational Site
      • Saint-Jean sur Richelieu, Quebec, Canada, J2X 2B2
        • GSK Investigational Site
      • Sainte Anne De Bellevue, Quebec, Canada, H9X 1M2
        • GSK Investigational Site
      • Sainte Catherine, Quebec, Canada, J0L 1E0
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 1V6
        • GSK Investigational Site
      • Sainte-Henri De Levis, Quebec, Canada, G0R 3E0
        • GSK Investigational Site
      • Salaberry-De-Valleyfield, Quebec, Canada, J6S 4Z5
        • GSK Investigational Site
      • Thetford Mines, Quebec, Canada, G6G 6H1
        • GSK Investigational Site
      • Vaudreuil, Quebec, Canada, J7V 8P9
        • GSK Investigational Site
      • Ville Lasalle, Quebec, Canada, H8N 1X9
        • GSK Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1N4
        • GSK Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7L 2W1
        • GSK Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7M 0Z6
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in HbA1c at week 48.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 25, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 16, 2005

Study Registration Dates

First Submitted

October 17, 2005

First Submitted That Met QC Criteria

October 17, 2005

First Posted (Estimate)

October 19, 2005

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 712753/008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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