Last updated: 11/04/2018 04:07:54
Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a registered trademark of the GSK group of companies.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 24 week, randomised, double blind, parallel study to compare the change in HbA1c with AVANDAMET® (8.0mg / 2.0g) plus insulin to placebo plus insulin, in subjects with type 2 diabetes starting insulin therapy
Trial description: This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in HbA1c
Timeframe: 24 weeks
Secondary outcomes:
Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction
Timeframe: 24 weeks
Interventions:
Drug: Rosiglitazone/metformin
Enrollment:
272
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Home P, Bailey C, Donaldson J, Chen H, Stewart M. A double-blind randomized study comparing the effects of continuing or not continuing rosiglitazone+metformin therapy when starting insulin therapy in people with type 2 diabetes. Diabetic Med 2007; 24. doi: 10.1111/j.1464-5491.2007.02141.x
Medical condition
Diabetes Mellitus, Type 2
Product
metformin, rosiglitazone, rosiglitazone/metformin
Collaborators
Not applicable
Study date(s)
October 2003 to November 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Patients must have been diagnosed with type II diabetes mellitus and not have adequate glycaemic controlled while receiving at least 1.5g of metformin.
- Patients must have a body mass index of greater than 25 kg/m2 and must not suffer from ankle swelling.
- Patients cannot have any form of congestive heart failure or severe or unstable angina.
- Patients cannot be currently receiving insulin, but be prepared to begin insulin treatment.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients must have been diagnosed with type II diabetes mellitus and not have adequate glycaemic controlled while receiving at least 1.5g of metformin.
- Patients must have a body mass index of greater than 25 kg/m2 and must not suffer from ankle swelling.
Exclusion criteria:
- Patients cannot have any form of congestive heart failure or severe or unstable angina.
- Patients cannot be currently receiving insulin, but be prepared to begin insulin treatment.
Trial location(s)
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44137
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68199
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52070
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
Location
GSK Investigational Site
Beckum, Nordrhein-Westfalen, Germany, 59269
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51065
Status
Study Complete
Location
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
Status
Study Complete
Location
GSK Investigational Site
Hermaringen, Baden-Wuerttemberg, Germany, 89568
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kippenheim, Baden-Wuerttemberg, Germany, 77971
Status
Study Complete
Location
GSK Investigational Site
Halberstadt, Sachsen-Anhalt, Germany, 38820
Status
Study Complete
Location
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
Status
Study Complete
Location
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31139
Status
Study Complete
Location
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
Status
Study Complete
Location
GSK Investigational Site
Speyer, Rheinland-Pfalz, Germany, 67346
Status
Study Complete
Location
GSK Investigational Site
Simmern, Rheinland-Pfalz, Germany, 55469
Status
Study Complete
Location
GSK Investigational Site
Pordenone, Friuli-Venezia-Giulia, Italy, 33170
Status
Study Complete
Location
GSK Investigational Site
Stockach, Baden-Wuerttemberg, Germany, 78333
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67061
Status
Study Complete
Location
GSK Investigational Site
Viersen, Nordrhein-Westfalen, Germany, 41751
Status
Study Complete
Location
GSK Investigational Site
Falkensee, Brandenburg, Germany, 14612
Status
Study Complete
Location
GSK Investigational Site
Altenkirchen, Rheinland-Pfalz, Germany, 57610
Status
Study Complete
Location
GSK Investigational Site
Roubaix, Nord-Pas-de-Calais, France, 59100
Status
Study Complete
Location
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41466
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
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
2004-16-11
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.
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