Last updated: 11/04/2018 04:07:36
AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: rosiglitazone/metformin
Enrollment:
600
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
metformin, rosiglitazone, rosiglitazone/metformin
Collaborators
Not applicable
Study date(s)
June 2003 to December 2005
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- 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.
- Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
- Have a known hypersensitivity to thiazolidinediones or biguanides.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7M 0Z6
Status
Study Complete
Location
GSK Investigational Site
Longueuil, Québec, Canada, J4N 1E1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1A 3R5
Status
Study Complete
Location
GSK Investigational Site
Edmonton, Alberta, Canada, T6L 6K3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Richelieu, Québec, Canada, J3L 4W6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ville Lasalle, Québec, Canada, H8N 1X9
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V7N 4M2
Status
Study Complete
Location
GSK Investigational Site
Sainte-Foy, Québec, Canada, G1V 1V6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salaberry-De-Valleyfield, Québec, Canada, J6S 4Z5
Status
Study Complete
Location
GSK Investigational Site
Dartmouth, Nova Scotia, Canada, B2W 2S8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 2X2
Status
Study Complete
Location
GSK Investigational Site
Richmond Hill, Ontario, Canada, L4C 2N9
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 3J1
Status
Study Complete
Location
GSK Investigational Site
Saint Charles Borromee, Québec, Canada, J6E 5A9
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5P 3T7
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 1N4
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5X 3T5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Calgary, Alberta, Canada, T3E 0C5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Upper Tantallon, Nova Scotia, Canada, B3Z 4R4
Status
Study Complete
Location
GSK Investigational Site
Calgary, Alberta, Canada, T3E 7C4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Toronto, Ontario, Canada, M2M 4J5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Smiths Falls, Ontario, Canada, K7A 2H6
Status
Study Complete
Location
GSK Investigational Site
Saint Leonard, Québec, Canada, H1S 3A9
Status
Study Complete
Location
GSK Investigational Site
Sainte Catherine, Québec, Canada, J0L 1E0
Status
Study Complete
Location
GSK Investigational Site
Peterborough, Ontario, Canada, K9H 1T6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Aldergrove, British Columbia, Canada, V4W 3L6
Status
Study Complete
Location
GSK Investigational Site
Brossard, Québec, Canada, J4Z 2K9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Calgary, Alberta, Canada, T2L 2V9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint-Jean sur Richelieu, Québec, Canada, J2X 2B2
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7L 2W1
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 3G8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3M 3W8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Medicine Hat, Alberta, Canada, T1A 6N9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Neguac, New Brunswick, Canada, E9G 4H3
Status
Study Complete
Location
GSK Investigational Site
Sainte Anne De Bellevue, Québec, Canada, H9X 1M2
Status
Study Complete
Location
GSK Investigational Site
Longueuil, Québec, Canada, J4J 3X5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Calgary, Alberta, Canada, T1Y 6J2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Burlington, Ontario, Canada, L7M 4Y1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Calgary, Alberta, Canada, T1Y 3R6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Carbonear, Newfoundland and Labrador, Canada, A1Y 1C4
Status
Study Complete
Location
GSK Investigational Site
Fredericton, New Brunswick, Canada, E5L 1S1
Status
Study Complete
Location
GSK Investigational Site
Sainte-Henri De Levis, Québec, Canada, G0R 3E0
Status
Study Complete
Location
GSK Investigational Site
Houston, New Brunswick, Canada, E6E 1H1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Calgary, Alberta, Canada, T3B 0M3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Thetford Mines, Québec, Canada, G6G 6H1
Status
Study Complete
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-16-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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