Clinical trial NCT00069836: Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: AVANDAMET insulin type 2 diabetes
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-10-03
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: 24 weeks
Secondary outcomes:
measure: Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
facility: GSK Investigational Site
city: Roubaix
country: France
facility: GSK Investigational Site
state: Nord-Pas-de-Calais
city: Angers
country: France
facility: GSK Investigational Site
city: Bondy Cedex
country: France
facility: GSK Investigational Site
city: Cholet
country: France
facility: GSK Investigational Site
city: Corbeil Essonnes Cedex
country: France
facility: GSK Investigational Site
city: Douai Cedex
country: France
facility: GSK Investigational Site
city: Epinay sur Orge
country: France
facility: GSK Investigational Site
city: La Rochelle Cedex 1
country: France
facility: GSK Investigational Site
city: Lorient
country: France
facility: GSK Investigational Site
city: Lyon Cedex 03
country: France
facility: GSK Investigational Site
city: Montbrison
country: France
facility: GSK Investigational Site
city: Nantes Cedex 1
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Pierre Benite Cedex
country: France
facility: GSK Investigational Site
city: Reims Cedex
country: France
facility: GSK Investigational Site
city: Rennes Cedex 2
country: France
facility: GSK Investigational Site
city: Saint Malo Cedex
country: France
facility: GSK Investigational Site
city: Toul Cedex
country: France
facility: GSK Investigational Site
city: Venissieux
country: France
facility: GSK Investigational Site
city: Hermaringen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kippenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Sinsheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stockach
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ilvesheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kuenzing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wallerfing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Falkensee
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Schwedt
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Bad Kreuznach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Schluechtern
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Vellmar
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hildesheim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Aachen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bad Oeynhausen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Beckum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Viersen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Altenkirchen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Ludwigshafen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Simmern
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Speyer
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Saarlouis
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Halberstadt
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Freital
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Pirna
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Gotha
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Schleiz
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Parma
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Pordenone
country: Italy
facility: GSK Investigational Site
state: Friuli-Venezia-Giulia
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Perugia
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Padova
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Treviso
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Alcobendas/Madrid
country: Spain
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Cadiz
country: Spain
facility: GSK Investigational Site
city: Galdakano
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Móstoles/Madrid
country: Spain
facility: GSK Investigational Site
city: Pontevedra
country: Spain
facility: GSK Investigational Site
city: Sabadell (Barcelona)
country: Spain
facility: GSK Investigational Site
city: San Juan De Alicante
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vigo/Pontevedra
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.