Last updated: 11/07/2018 15:48:44
AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, multi-centre, phase IV, double-blind, parallel group study comparing the effects of 52 weeks administration of AVANDAMET and metformin plus sulphonylurea on change in HbA1c from baseline in overweight type 2 diabetics poorly controlled on metformin.
Trial description: This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
544
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Exp Clin Endocrinol Diabetes 2008; 116: 6– 13
Medical condition
Non-Insulin-Dependent Diabetes Mellitus
Product
metformin, rosiglitazone, rosiglitazone/metformin
Collaborators
Not applicable
Study date(s)
February 2004 to January 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 75 Years
Accepts healthy volunteers
No
- Body mass index > or = to 25 kg/m2.
- HbA1c > or =7% and < or =10% at screening.
- Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
- Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
Inclusion and exclusion criteria
Inclusion criteria:
- Body mass index > or = to 25 kg/m2.
- HbA1c > or =7% and < or =10% at screening.
- FPG > or = 7.0mmol/L (126mg/dL) at visit 2.
- Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
- Female subjects must be postmenopausal or using effective contraceptive measures.
Exclusion criteria:
- Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
- Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
- Subjects with a history of severe hypoglycaemia.
- Renal disease or renal dysfunction.
- Presence of clinically significant hepatic disease.
- Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure.
- Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.
Trial location(s)
Showing 1 - 6 of 142 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
2006-09-01
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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