AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes

Non-Insulin-Dependent Diabetes Mellitus Clinical Trial

Official title:

A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359112
• Other study ID #: AVM100264
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2006
• Last updated: May 15, 2009
• Start date: February 2004

Study information

• Verified date: May 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 544
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Body mass index > or = to 25 kg/m2.

• HbA1c > or =7% and < or =10% at screening.

• FPG > or = 7.0mmol/L (126mg/dL) at visit 2.

• Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.

• Female subjects must be postmenopausal or using effective contraceptive measures.

Exclusion criteria:

• Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.

• Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.

• Subjects with a history of severe hypoglycaemia.

• Renal disease or renal dysfunction.

• Presence of clinically significant hepatic disease.

• Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure.

• Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Non-Insulin-Dependent Diabetes Mellitus

Intervention

Drug:
• metformin

• sulphonylurea

• Avandamet

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Brugge
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Heverlee
Belgium	GSK Investigational Site	Landen
Belgium	GSK Investigational Site	Namur (Champion)
Belgium	GSK Investigational Site	Oostham
Belgium	GSK Investigational Site	Petit-Rechain
Belgium	GSK Investigational Site	Tessenderlo
Belgium	GSK Investigational Site	Tremelo
Belgium	GSK Investigational Site	Willebroek
Belgium	GSK Investigational Site	Zandhoven (Pulle)
France	GSK Investigational Site	Anzin
France	GSK Investigational Site	Briollay
France	GSK Investigational Site	Commelle Vernay
France	GSK Investigational Site	Cremeaux
France	GSK Investigational Site	Evron
France	GSK Investigational Site	Laval
France	GSK Investigational Site	Louverne
France	GSK Investigational Site	Lyon
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Roanne
France	GSK Investigational Site	Roubaix	Nord-Pas-de-Calais
France	GSK Investigational Site	Saint Ouen
France	GSK Investigational Site	Sainte Suzanne
France	GSK Investigational Site	Segré
France	GSK Investigational Site	Venissieux
Germany	GSK Investigational Site	Beckum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bergkamen-Rünthe	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dinslaken	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dortmund	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Einbeck	Niedersachsen
Germany	GSK Investigational Site	Elmshorn	Schleswig-Holstein
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Grafing	Bayern
Germany	GSK Investigational Site	Grossalmerode	Hessen
Germany	GSK Investigational Site	Gueglingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Herzogenaurach	Bayern
Germany	GSK Investigational Site	Immenstadt	Bayern
Germany	GSK Investigational Site	Isernhagen	Niedersachsen
Germany	GSK Investigational Site	Kippenheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koenigsfeld	Baden-Wuerttemberg
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Neuwied	Rheinland-Pfalz
Germany	GSK Investigational Site	Oberteisendorf	Bayern
Germany	GSK Investigational Site	Papenburg	Niedersachsen
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Saaldorf-Surheim	Bayern
Germany	GSK Investigational Site	Saarlouis	Saarland
Germany	GSK Investigational Site	Speyer	Rheinland-Pfalz
Germany	GSK Investigational Site	Viersen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Waldshut-Tiengen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wallerfing	Bayern
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wolmirstedt	Sachsen-Anhalt
Germany	GSK Investigational Site	Wuerzburg	Bayern
Ireland	GSK Investigational Site	Blanchardstown
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Italy	GSK Investigational Site	Arenzano (GE)	Liguria
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Italy	GSK Investigational Site	Città di Castello (PG)	Umbria
Italy	GSK Investigational Site	Ferrara	Emilia-Romagna
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Ravenna	Emilia-Romagna
Italy	GSK Investigational Site	Sassari	Sardegna
Italy	GSK Investigational Site	Terni	Umbria
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Mexico, D.F.
Mexico	GSK Investigational Site	Pachuca	Hidalgo
Mexico	GSK Investigational Site	Tijuana	Baja California Norte
Netherlands	GSK Investigational Site	Beek En Donk
Netherlands	GSK Investigational Site	Beerzerveld
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Heerlen
Netherlands	GSK Investigational Site	Hoogvliet
Netherlands	GSK Investigational Site	Landgraaf
Netherlands	GSK Investigational Site	Musselkanaal
Netherlands	GSK Investigational Site	Oude Pekela
Netherlands	GSK Investigational Site	Spijkenisse
Netherlands	GSK Investigational Site	Woerden
Netherlands	GSK Investigational Site	Zaandam
Netherlands	GSK Investigational Site	Zieuwent
Spain	GSK Investigational Site	Alcobendas/Madrid
Spain	GSK Investigational Site	Alcora/Castellón
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Alzira
Spain	GSK Investigational Site	Artana/Castellón
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Benicassim (Castellon)
Spain	GSK Investigational Site	Cáceres
Spain	GSK Investigational Site	Cadiz
Spain	GSK Investigational Site	Castellón
Spain	GSK Investigational Site	Gerona
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Merida
Spain	GSK Investigational Site	Móstoles/Madrid
Spain	GSK Investigational Site	Onda (Castellon)
Spain	GSK Investigational Site	Pontevedra
Spain	GSK Investigational Site	Sabadell (Barcelona)
Spain	GSK Investigational Site	San Juan De Alicante
Spain	GSK Investigational Site	Sta Coloma de Gramanet (Barcelona)
Spain	GSK Investigational Site	Tarrasa, Barcelona
Spain	GSK Investigational Site	Valencia
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Emmenbrücke
Switzerland	GSK Investigational Site	Gettnau
Switzerland	GSK Investigational Site	Jegenstorf
Switzerland	GSK Investigational Site	Lugano
Switzerland	GSK Investigational Site	Luzern
Switzerland	GSK Investigational Site	Pregassona
Switzerland	GSK Investigational Site	Salmsach
Switzerland	GSK Investigational Site	St. Maurice
Switzerland	GSK Investigational Site	Steckborn
Switzerland	GSK Investigational Site	Winterthur
Switzerland	GSK Investigational Site	Winterthur
Switzerland	GSK Investigational Site	Zürich
Switzerland	GSK Investigational Site	Zürich
United Kingdom	GSK Investigational Site	Bath	Somerset
United Kingdom	GSK Investigational Site	Blackpool	Lancashire
United Kingdom	GSK Investigational Site	Bristol
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Leeds
United Kingdom	GSK Investigational Site	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Ireland,  Italy,  Lithuania,  Mexico,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c level from baseline following 52 weeks of treatment.
Secondary	Change in FPG (fasting plasma glucose)
Secondary	insulin sensitivity
Secondary	beta cell function
Secondary	change in PAI-1
Secondary	CRP
Secondary	number of hypoglycaemic events
Secondary	Change in 24 hr ABPM
Secondary	Diabetes treatment satisfaction.