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
Study complete
Study complete
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:
Enrollment:
600
Primary completion date:
Not applicable
Observational study model:
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
Charlesbourg, Québec, Canada, G1G 4A2
Status
Study Complete
Showing 1 - 6 of 91 Results
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
Study complete
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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