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
Completed
Completed
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:
Drug: metformin
Drug: sulphonylurea
Drug: Avandamet
Enrollment:
544
Observational study model:
Not applicable
Primary completion date:
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)
Location
GSK Investigational Site
Saaldorf-Surheim, Bayern, Germany, 83416
Status
Study Complete
Location
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY4 3AD
Status
Study Complete
Location
GSK Investigational Site
Città di Castello (PG), Umbria, Italy, 06012
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G3 8YJ
Status
Study Complete
Location
GSK Investigational Site
Oberteisendorf, Bayern, Germany, 83317
Status
Study Complete
Location
GSK Investigational Site
Papenburg, Niedersachsen, Germany, 26871
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44869
Status
Study Complete
Location
GSK Investigational Site
Roubaix, Nord-Pas-de-Calais, France, 59100
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30519
Status
Study Complete
Location
GSK Investigational Site
Dinslaken, Nordrhein-Westfalen, Germany, 46537
Status
Study Complete
Location
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
Status
Study Complete
Location
GSK Investigational Site
Sta Coloma de Gramanet (Barcelona), Spain, 08923
Status
Study Complete
Location
GSK Investigational Site
Viersen, Nordrhein-Westfalen, Germany, 41749
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Waldshut-Tiengen, Baden-Wuerttemberg, Germany, 79961
Status
Study Complete
Location
GSK Investigational Site
Herzogenaurach, Bayern, Germany, 91074
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45134
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Einbeck, Niedersachsen, Germany, 37574
Status
Study Complete
Location
GSK Investigational Site
Isernhagen, Niedersachsen, Germany, 30916
Status
Study Complete
Location
GSK Investigational Site
Neuwied, Rheinland-Pfalz, Germany, 56564
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Speyer, Rheinland-Pfalz, Germany, 67346
Status
Study Complete
Location
GSK Investigational Site
Wolmirstedt, Sachsen-Anhalt, Germany, 39326
Status
Study Complete
Location
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
Status
Study Complete
Location
GSK Investigational Site
Beckum, Nordrhein-Westfalen, Germany, 59269
Status
Study Complete
Location
GSK Investigational Site
Bergkamen-Rünthe, Nordrhein-Westfalen, Germany, 59192
Status
Study Complete
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44137
Status
Study Complete
Location
GSK Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG
Status
Study Complete
Location
GSK Investigational Site
Tijuana, Baja California Norte, Mexico, 22320
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G69 7AD
Status
Study Complete
Location
GSK Investigational Site
Tarrasa, Barcelona, Spain, 08221
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kippenheim, Baden-Wuerttemberg, Germany, 77971
Status
Study Complete
Location
GSK Investigational Site
Koenigsfeld, Baden-Wuerttemberg, Germany, 78126
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
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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