Study Of AVANDAMET With Or Without Insulin In Type II Diabetes Mellitus Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00069836
First received: October 1, 2003
Last updated: February 11, 2013
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Non-Insulin-Dependent Diabetes Mellitus
Drug: Rosiglitazone/metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET* (8.0 mg / 2.0 g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction [ Time Frame: 24 weeks ]

Estimated Enrollment: 272
Study Start Date: October 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosiglitazone/metformin
    Other Name: Rosiglitazone/metformin
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069836

  Hide Study Locations
Locations
Austria
GSK Investigational Site
Vienna, Austria, A-1030
GSK Investigational Site
Vienna, Austria, A-1060
France
GSK Investigational Site
Roubaix, Nord-Pas-de-Calais, France, 59100
GSK Investigational Site
Angers, France, 49000
GSK Investigational Site
Bondy Cedex, France, 93143
GSK Investigational Site
Cholet, France, 49300
GSK Investigational Site
Corbeil Essonnes Cedex, France, 91106
GSK Investigational Site
Douai Cedex, France, 59507
GSK Investigational Site
Epinay sur Orge, France, 91360
GSK Investigational Site
La Rochelle Cedex 1, France, 17019
GSK Investigational Site
Lorient, France, 56322
GSK Investigational Site
Lyon Cedex 03, France, 69394
GSK Investigational Site
Montbrison, France, 42600
GSK Investigational Site
Nantes Cedex 1, France, 44093
GSK Investigational Site
Paris, France, 75015
GSK Investigational Site
Pierre Benite Cedex, France, 69495
GSK Investigational Site
Reims Cedex, France, 51092
GSK Investigational Site
Rennes Cedex 2, France, 35203
GSK Investigational Site
Toul Cedex, France, 54201
GSK Investigational Site
Venissieux, France, 69200
Germany
GSK Investigational Site
Kippenheim, Baden-Wuerttemberg, Germany, 77971
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68199
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
GSK Investigational Site
Stockach, Baden-Wuerttemberg, Germany, 78333
GSK Investigational Site
Ilvesheim, Bayern, Germany, 68549
GSK Investigational Site
Kuenzing, Bayern, Germany, 94550
GSK Investigational Site
Muenchen, Bayern, Germany, 80469
GSK Investigational Site
Muenchen, Bayern, Germany, 81549
GSK Investigational Site
Muenchen, Bayern, Germany, 81373
GSK Investigational Site
Wallerfing, Bayern, Germany, 94574
GSK Investigational Site
Falkensee, Brandenburg, Germany, 14612
GSK Investigational Site
Potsdam, Brandenburg, Germany, 14467
GSK Investigational Site
Schwedt, Brandenburg, Germany, 16303
GSK Investigational Site
Bad Kreuznach, Hessen, Germany, 55545
GSK Investigational Site
Frankfurt, Hessen, Germany, 60326
GSK Investigational Site
Schluechtern, Hessen, Germany, 36381
GSK Investigational Site
Vellmar, Hessen, Germany, 34246
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31139
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52070
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
GSK Investigational Site
Beckum, Nordrhein-Westfalen, Germany, 59269
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44137
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51065
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41466
GSK Investigational Site
Viersen, Nordrhein-Westfalen, Germany, 41751
GSK Investigational Site
Altenkirchen, Rheinland-Pfalz, Germany, 57610
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67061
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
GSK Investigational Site
Simmern, Rheinland-Pfalz, Germany, 55469
GSK Investigational Site
Speyer, Rheinland-Pfalz, Germany, 67346
GSK Investigational Site
Saarlouis, Saarland, Germany, 66740
GSK Investigational Site
Halberstadt, Sachsen-Anhalt, Germany, 38820
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06112
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06114
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Dresden, Sachsen, Germany, 01219
GSK Investigational Site
Freital, Sachsen, Germany, 01705
GSK Investigational Site
Pirna, Sachsen, Germany, 01796
GSK Investigational Site
Gotha, Thueringen, Germany, 99867
GSK Investigational Site
Schleiz, Thueringen, Germany, 07907
GSK Investigational Site
Berlin, Germany, 12347
GSK Investigational Site
Berlin, Germany, 13057
GSK Investigational Site
Berlin, Germany, 12351
GSK Investigational Site
Berlin, Germany, 10789
GSK Investigational Site
Hamburg, Germany, 22607
GSK Investigational Site
Hamburg, Germany, 20246
GSK Investigational Site
Hamburg, Germany, 22041
Italy
GSK Investigational Site
Parma, Emilia-Romagna, Italy, 43100
GSK Investigational Site
Pordenone, Friuli-Venezia-Giulia, Italy, 33170
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Perugia, Umbria, Italy, 06126
GSK Investigational Site
Padova, Veneto, Italy, 35128
GSK Investigational Site
Treviso, Veneto, Italy, 31100
Spain
GSK Investigational Site
Alcobendas/Madrid, Spain, 28100
GSK Investigational Site
Alicante, Spain
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 08022
GSK Investigational Site
Cadiz, Spain, 11009
GSK Investigational Site
Galdakano, Spain, 48960
GSK Investigational Site
Granada, Spain, 18012
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain, 28006
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
GSK Investigational Site
Pontevedra, Spain, 36002
GSK Investigational Site
Sabadell (Barcelona), Spain, 08208
GSK Investigational Site
San Juan De Alicante, Spain, 3550
GSK Investigational Site
Valencia, Spain, 46010
GSK Investigational Site
Vigo/Pontevedra, Spain, 36200
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00069836     History of Changes
Other Study ID Numbers: 712753/009
Study First Received: October 1, 2003
Last Updated: February 11, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
AVANDAMET insulin type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014