Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069836
• Other study ID #: 712753/009
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2003
• Last updated: August 31, 2016
• Start date: October 2003
• Est. completion date: November 2004

Study information

• Verified date: August 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Rosiglitazone/metformin

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
France	GSK Investigational Site	Angers
France	GSK Investigational Site	Bondy Cedex
France	GSK Investigational Site	Cholet
France	GSK Investigational Site	Corbeil Essonnes Cedex
France	GSK Investigational Site	Douai Cedex
France	GSK Investigational Site	Epinay sur Orge
France	GSK Investigational Site	La Rochelle Cedex 1
France	GSK Investigational Site	Lorient
France	GSK Investigational Site	Lyon Cedex 03
France	GSK Investigational Site	Montbrison
France	GSK Investigational Site	Nantes Cedex 1
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Pierre Benite Cedex
France	GSK Investigational Site	Reims Cedex
France	GSK Investigational Site	Rennes Cedex 2
France	GSK Investigational Site	Roubaix	Nord-Pas-de-Calais
France	GSK Investigational Site	Saint Malo Cedex
France	GSK Investigational Site	Toul Cedex
France	GSK Investigational Site	Venissieux
Germany	GSK Investigational Site	Aachen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Altenkirchen	Rheinland-Pfalz
Germany	GSK Investigational Site	Bad Kreuznach	Hessen
Germany	GSK Investigational Site	Bad Oeynhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Beckum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Falkensee	Brandenburg
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Freital	Sachsen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Gotha	Thueringen
Germany	GSK Investigational Site	Halberstadt	Sachsen-Anhalt
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hermaringen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hildesheim	Niedersachsen
Germany	GSK Investigational Site	Ilvesheim	Bayern
Germany	GSK Investigational Site	Kippenheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Kuenzing	Bayern
Germany	GSK Investigational Site	Ludwigshafen	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen
Germany	GSK Investigational Site	Pirna	Sachsen
Germany	GSK Investigational Site	Potsdam	Brandenburg
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Saarlouis	Saarland
Germany	GSK Investigational Site	Schleiz	Thueringen
Germany	GSK Investigational Site	Schluechtern	Hessen
Germany	GSK Investigational Site	Schwedt	Brandenburg
Germany	GSK Investigational Site	Simmern	Rheinland-Pfalz
Germany	GSK Investigational Site	Sinsheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Speyer	Rheinland-Pfalz
Germany	GSK Investigational Site	Stockach	Baden-Wuerttemberg
Germany	GSK Investigational Site	Vellmar	Hessen
Germany	GSK Investigational Site	Viersen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wallerfing	Bayern
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Parma	Emilia-Romagna
Italy	GSK Investigational Site	Perugia	Umbria
Italy	GSK Investigational Site	Pordenone	Friuli-Venezia-Giulia
Italy	GSK Investigational Site	Treviso	Veneto
Spain	GSK Investigational Site	Alcobendas/Madrid
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Cadiz
Spain	GSK Investigational Site	Galdakano
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Móstoles/Madrid
Spain	GSK Investigational Site	Pontevedra
Spain	GSK Investigational Site	Sabadell (Barcelona)
Spain	GSK Investigational Site	San Juan De Alicante
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vigo/Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Spain, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		24 weeks
Secondary	Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction		24 weeks

External Links

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