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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
272
GSK Investigational Site
Vienna, Austria
GSK Investigational Site
Vienna, Austria
GSK Investigational Site
Roubaix, Hauts-de-France, France
GSK Investigational Site
Angers, France
GSK Investigational Site
Bondy, France
GSK Investigational Site
Change from baseline in HbA1c
Time frame: 24 weeks
Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction
Time frame: 24 weeks
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Cholet, France
GSK Investigational Site
Corbeil-Essonnes, France
GSK Investigational Site
Douai, France
GSK Investigational Site
Épinay-sur-Orge, France
GSK Investigational Site
La Rochelle, France
...and 83 more locations