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Diabetes Mellitus, Type 2Phase 4NCT00241605

AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus

A Phase 4 study testing rosiglitazone/metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 91 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
rosiglitazone/metformin
How many people
600 participants
Where
91 sitesCanada
Study dates
25 Jun 2003to 16 Dec 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

91 sites in 1 country.

91 sites in 1 country

Canada91 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 6N2

  • GSK Investigational Site

    Aldergrove, British Columbia, V4W 3L6

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Brampton, Ontario, L6T 3T1

  • GSK Investigational Site

    Brampton, Ontario, L6T 4S5

  • GSK Investigational Site

    Brossard, Quebec, J4Z 2K9

  • GSK Investigational Site

    Burlington, Ontario, L7M 4Y1

  • GSK Investigational Site

    Calgary, Alberta, T1Y 3R6

  • GSK Investigational Site

    Calgary, Alberta, T1Y 6J2

  • GSK Investigational Site

    Calgary, Alberta, T2A 0P9

  • GSK Investigational Site

    Calgary, Alberta, T2L 2V9

  • GSK Investigational Site

    Calgary, Alberta, T3B 0M3

  • GSK Investigational Site

    Calgary, Alberta, T3E 0C5

  • GSK Investigational Site

    Calgary, Alberta, T3E 7C4

  • GSK Investigational Site

    Cambridge, Ontario, N3C 1Z3

  • GSK Investigational Site

    Carbonear, Newfoundland and Labrador, A1Y 1C4

  • GSK Investigational Site

    Charlesbourg, Quebec, G1G 4A2

  • GSK Investigational Site

    Charlesbourg, Quebec, G1H 6P2

  • GSK Investigational Site

    Châteauguay, Quebec, J6K 3A9

  • GSK Investigational Site

    Courcelette, Quebec, G0A 1R1

  • GSK Investigational Site

    Cowansville, Quebec, J2K 2X9

  • GSK Investigational Site

    Dartmouth, Nova Scotia, B2W 2S8

  • GSK Investigational Site

    Edmonton, Alberta, T5A 4L8

  • GSK Investigational Site

    Edmonton, Alberta, T6L 6K3

  • GSK Investigational Site

    Fort Erie, Ontario, L2A 1Z3

  • GSK Investigational Site

    Fredericton, New Brunswick, E5L 1S1

  • GSK Investigational Site

    Halifax, Nova Scotia, B3M 3W8

  • GSK Investigational Site

    Hamilton, Ontario, L8L 5G8

  • GSK Investigational Site

    Houston, New Brunswick, E6E 1H1

  • GSK Investigational Site

    Hull, Quebec, J8Y 2E2

  • GSK Investigational Site

    Innisfil, Ontario, L9S 1L2

  • GSK Investigational Site

    Kelowna, British Columbia, V1Y 3G8

  • GSK Investigational Site

    Kingston, Ontario, K7M 1W9

  • GSK Investigational Site

    Lambton, Quebec, G0M 1H0

  • GSK Investigational Site

    Lle Perrot, Quebec, H8Y 3J2

  • GSK Investigational Site

    London, Ontario, N5Y 3J8

  • GSK Investigational Site

    London, Ontario, N6P 1A9

  • GSK Investigational Site

    Longueuil, Quebec, J4J 3X5

  • GSK Investigational Site

    Longueuil, Quebec, J4N 1E1

  • GSK Investigational Site

    Longueuil, Quebec, J4N 1L6

  • GSK Investigational Site

    Medicine Hat, Alberta, T1A 6N9

  • GSK Investigational Site

    Mississauga, Ontario, L5B 3A8

  • GSK Investigational Site

    Mississauga, Ontario, L5B 4A9

  • GSK Investigational Site

    Montreal, Quebec, H1M 2M1

  • GSK Investigational Site

    Montreal, Quebec, H4N 2W2

  • GSK Investigational Site

    Neguac, New Brunswick, E9G 4H3

  • GSK Investigational Site

    North York, Ontario, M3M 3E5

  • GSK Investigational Site

    Oakville, Ontario, L6L 2X4

  • GSK Investigational Site

    Oshawa, Ontario, L1H 1C2

  • GSK Investigational Site

    Ottawa, Ontario, K2G 6E2

  • GSK Investigational Site

    Peterborough, Ontario, K9H 1T6

  • GSK Investigational Site

    Pierrefonds, Quebec, H8Y 3J2

  • GSK Investigational Site

    Pointe-Claire, Quebec, H9R 3J1

  • GSK Investigational Site

    Québec, G1N 1E1

  • GSK Investigational Site

    Rexdale, Ontario, M9V 4B9

  • GSK Investigational Site

    Richelieu, Quebec, J3L 4W6

  • GSK Investigational Site

    Richmond Hill, Ontario, L4C 2N9

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 5A9

  • GSK Investigational Site

    Saint-Jean-sur-Richelieu, Quebec, J2X 2B2

  • GSK Investigational Site

    Saint-Léonard, Quebec, H1S 3A9

  • GSK Investigational Site

    Sainte-Anne-de-Bellevue, Quebec, H9X 1M2

  • GSK Investigational Site

    Sainte-Catherine, Quebec, J0L 1E0

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 1V6

  • GSK Investigational Site

    Sainte-Henri de Levis, Quebec, G0R 3E0

  • GSK Investigational Site

    Salaberry-de-Valleyfield, Quebec, J6S 4Z5

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7K 1N4

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7L 2W1

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7M 0Z6

  • GSK Investigational Site

    Scarborough Village, Ontario, M1J 2E5

  • GSK Investigational Site

    Scarborough Village, Ontario, M1R 1R9

  • GSK Investigational Site

    Smiths Falls, Ontario, K7A 2H6

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1A 3R5

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 2X2

  • GSK Investigational Site

    Sutton, Ontario, L0E 1R0

  • GSK Investigational Site

    Thetford-Mines, Quebec, G6G 6H1

  • GSK Investigational Site

    Toronto, Ontario, M2M 4J5

  • GSK Investigational Site

    Toronto, Ontario, M5G 1E2

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Upper Tantallon, Nova Scotia, B3Z 4R4

  • GSK Investigational Site

    Vancouver, British Columbia, V5P 3T7

  • GSK Investigational Site

    Vancouver, British Columbia, V5X 3T5

  • GSK Investigational Site

    Vancouver, British Columbia, V7N 4M2

  • GSK Investigational Site

    Vaudreuil, Quebec, J7V 8P9

  • GSK Investigational Site

    Ville Lasalle, Quebec, H8N 1X9

  • GSK Investigational Site

    Windsor, Ontario, B0N 2T0

  • GSK Investigational Site

    Winnipeg, Manitoba, R2H 0R8

  • GSK Investigational Site

    Winnipeg, Manitoba, R2J 4A7

  • GSK Investigational Site

    Winnipeg, Manitoba, R3A 1M3

  • GSK Investigational Site

    Woodbridge, Ontario, L4L 8E2

  • GSK Investigational Site

    Woodstock, Ontario, E7M 1H1

  • GSK Investigational Site

    Woodstock, Ontario, N4S 4H4

Other trials in Canada

About this study

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.

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

Being tested
rosiglitazone/metformin
Keywords
Metformin, AVANDAMET, Type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rosiglitazone/metforminDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HbA1c at week 48.

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2005 (estimated)
  2. Study start25 Jun 2003
  3. Primary completion1 Dec 2005
  4. Study completion16 Dec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00241605
Sponsor's protocol ID
712753/008
Status last verified
Mar 2018
First submitted
17 Oct 2005
Last updated
21 Mar 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rosiglitazone/metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 91 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in HbA1c at week 48.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00241605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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