Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.
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
1 other identifier
interventional
272
5 countries
93
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Oct 2003
Shorter than P25 for phase_3 diabetes-mellitus-type-2
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2003
CompletedStudy Start
First participant enrolled
October 1, 2003
CompletedFirst Posted
Study publicly available on registry
October 3, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedSeptember 1, 2016
August 1, 2016
1.1 years
October 1, 2003
August 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c
24 weeks
Secondary Outcomes (1)
Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction
24 weeks
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (93)
GSK Investigational Site
Vienna, A-1030, Austria
GSK Investigational Site
Vienna, A-1060, Austria
GSK Investigational Site
Roubaix, Hauts-de-France, 59100, France
GSK Investigational Site
Angers, 49000, France
GSK Investigational Site
Bondy, 93143, France
GSK Investigational Site
Cholet, 49300, France
GSK Investigational Site
Corbeil-Essonnes, 91106, France
GSK Investigational Site
Douai, 59507, France
GSK Investigational Site
Épinay-sur-Orge, 91360, France
GSK Investigational Site
La Rochelle, 17019, France
GSK Investigational Site
Lorient, 56322, France
GSK Investigational Site
Lyon, 69394, France
GSK Investigational Site
Montbrison, 42600, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Paris, 75015, France
GSK Investigational Site
Pierre-Bénite, 69495, France
GSK Investigational Site
Reims, 51092, France
GSK Investigational Site
Rennes, 35203, France
GSK Investigational Site
St-Malo, 35403, France
GSK Investigational Site
Toul, 54201, France
GSK Investigational Site
Vénissieux, 69200, France
GSK Investigational Site
Hermaringen, Baden-Wurttemberg, 89568, Germany
GSK Investigational Site
Kippenheim, Baden-Wurttemberg, 77971, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68199, Germany
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889, Germany
GSK Investigational Site
Stockach, Baden-Wurttemberg, 78333, Germany
GSK Investigational Site
Ilvesheim, Bavaria, 68549, Germany
GSK Investigational Site
Künzing, Bavaria, 94550, Germany
GSK Investigational Site
Munich, Bavaria, 80469, Germany
GSK Investigational Site
Munich, Bavaria, 81373, Germany
GSK Investigational Site
Munich, Bavaria, 81549, Germany
GSK Investigational Site
Wallerfing, Bavaria, 94574, Germany
GSK Investigational Site
Falkensee, Brandenburg, 14612, Germany
GSK Investigational Site
Potsdam, Brandenburg, 14467, Germany
GSK Investigational Site
Schwedt, Brandenburg, 16303, Germany
GSK Investigational Site
Hamburg, Hamburg, 20246, Germany
GSK Investigational Site
Hamburg, Hamburg, 22041, Germany
GSK Investigational Site
Hamburg, Hamburg, 22607, Germany
GSK Investigational Site
Bad Kreuznach, Hesse, 55545, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60326, Germany
GSK Investigational Site
Schlüchtern, Hesse, 36381, Germany
GSK Investigational Site
Vellmar, Hesse, 34246, Germany
GSK Investigational Site
Hildesheim, Lower Saxony, 31139, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52070, Germany
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549, Germany
GSK Investigational Site
Beckum, North Rhine-Westphalia, 59269, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51065, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574, Germany
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41466, Germany
GSK Investigational Site
Viersen, North Rhine-Westphalia, 41751, Germany
GSK Investigational Site
Altenkirchen, Rhineland-Palatinate, 57610, Germany
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67061, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624, Germany
GSK Investigational Site
Simmern, Rhineland-Palatinate, 55469, Germany
GSK Investigational Site
Speyer, Rhineland-Palatinate, 67346, Germany
GSK Investigational Site
Saarlouis, Saarland, 66740, Germany
GSK Investigational Site
Dresden, Saxony, 01219, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Freital, Saxony, 01705, Germany
GSK Investigational Site
Pirna, Saxony, 01796, Germany
GSK Investigational Site
Halberstadt, Saxony-Anhalt, 38820, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, 06112, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, 06114, Germany
GSK Investigational Site
Berlin, State of Berlin, 10789, Germany
GSK Investigational Site
Berlin, State of Berlin, 12347, Germany
GSK Investigational Site
Berlin, State of Berlin, 12351, Germany
GSK Investigational Site
Berlin, State of Berlin, 13057, Germany
GSK Investigational Site
Gotha, Thuringia, 99867, Germany
GSK Investigational Site
Schleiz, Thuringia, 07907, Germany
GSK Investigational Site
Parma, Emilia-Romagna, 43100, Italy
GSK Investigational Site
Pordenone, Friuli Venezia Giulia, 33170, Italy
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Perugia, Umbria, 06126, Italy
GSK Investigational Site
Padua, Veneto, 35128, Italy
GSK Investigational Site
Treviso, Veneto, 31100, Italy
GSK Investigational Site
Alcobendas/Madrid, 28100, Spain
GSK Investigational Site
Alicante, Spain
GSK Investigational Site
Barcelona, 08022, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Cadiz, 11009, Spain
GSK Investigational Site
Galdakano, 48960, Spain
GSK Investigational Site
Granada, 18012, Spain
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Móstoles/Madrid, 28935, Spain
GSK Investigational Site
Pontevedra, 36002, Spain
GSK Investigational Site
Sabadell (Barcelona), 08208, Spain
GSK Investigational Site
Sant Joan d'Alacant, 3550, Spain
GSK Investigational Site
Valencia, 46010, Spain
GSK Investigational Site
Vigo/Pontevedra, 36200, Spain
Related Publications (1)
Home PD, Bailey CJ, Donaldson J, Chen H, Stewart MW. 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. Diabet Med. 2007 Jun;24(6):618-25. doi: 10.1111/j.1464-5491.2007.02141.x. Epub 2007 Apr 2.
PMID: 17403121RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2003
First Posted
October 3, 2003
Study Start
October 1, 2003
Primary Completion
November 1, 2004
Study Completion
November 1, 2004
Last Updated
September 1, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.