Clinical trial NCT00359112: AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Insulin-Dependent Diabetes Mellitus
Keywords: Type 2 diabetes
overweight
AVANDAMET
metformin
sulphonylurea
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c level from baseline following 52 weeks of treatment.
Secondary outcomes:
measure: Change in FPG (fasting plasma glucose)
measure: insulin sensitivity
measure: beta cell function
measure: change in PAI-1
measure: CRP
measure: number of hypoglycaemic events
measure: Change in 24 hr ABPM
measure: Diabetes treatment satisfaction.
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Heverlee
country: Belgium
facility: GSK Investigational Site
city: Landen
country: Belgium
facility: GSK Investigational Site
city: Namur (Champion)
country: Belgium
facility: GSK Investigational Site
city: Oostham
country: Belgium
facility: GSK Investigational Site
city: Petit-Rechain
country: Belgium
facility: GSK Investigational Site
city: Tessenderlo
country: Belgium
facility: GSK Investigational Site
city: Tremelo
country: Belgium
facility: GSK Investigational Site
city: Willebroek
country: Belgium
facility: GSK Investigational Site
city: Zandhoven (Pulle)
country: Belgium
facility: GSK Investigational Site
city: Roubaix
country: France
facility: GSK Investigational Site
state: Nord-Pas-de-Calais
city: Anzin
country: France
facility: GSK Investigational Site
city: Briollay
country: France
facility: GSK Investigational Site
city: Commelle Vernay
country: France
facility: GSK Investigational Site
city: Cremeaux
country: France
facility: GSK Investigational Site
city: Evron
country: France
facility: GSK Investigational Site
city: Laval
country: France
facility: GSK Investigational Site
city: Louverne
country: France
facility: GSK Investigational Site
city: Lyon
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Roanne
country: France
facility: GSK Investigational Site
city: Saint Ouen
country: France
facility: GSK Investigational Site
city: Sainte Suzanne
country: France
facility: GSK Investigational Site
city: Segré
country: France
facility: GSK Investigational Site
city: Venissieux
country: France
facility: GSK Investigational Site
city: Gueglingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kippenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Koenigsfeld
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Waldshut-Tiengen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Grafing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Herzogenaurach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Immenstadt
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Oberteisendorf
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Saaldorf-Surheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wallerfing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Grossalmerode
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Einbeck
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Isernhagen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Papenburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Beckum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bergkamen-Rünthe
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dinslaken
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dortmund
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
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: Viersen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Neuwied
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
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: Wolmirstedt
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Elmshorn
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Blanchardstown
country: Ireland
facility: GSK Investigational Site
city: Dublin
country: Ireland
facility: GSK Investigational Site
city: Dublin
country: Ireland
facility: GSK Investigational Site
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Ferrara
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Arenzano (GE)
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Sassari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Città di Castello (PG)
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Terni
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Tijuana
country: Mexico
facility: GSK Investigational Site
state: Baja California Norte
city: Pachuca
country: Mexico
facility: GSK Investigational Site
state: Hidalgo
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Beek En Donk
country: Netherlands
facility: GSK Investigational Site
city: Beerzerveld
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Heerlen
country: Netherlands
facility: GSK Investigational Site
city: Hoogvliet
country: Netherlands
facility: GSK Investigational Site
city: Landgraaf
country: Netherlands
facility: GSK Investigational Site
city: Musselkanaal
country: Netherlands
facility: GSK Investigational Site
city: Oude Pekela
country: Netherlands
facility: GSK Investigational Site
city: Spijkenisse
country: Netherlands
facility: GSK Investigational Site
city: Woerden
country: Netherlands
facility: GSK Investigational Site
city: Zaandam
country: Netherlands
facility: GSK Investigational Site
city: Zieuwent
country: Netherlands
facility: GSK Investigational Site
city: Alcobendas/Madrid
country: Spain
facility: GSK Investigational Site
city: Alcora/Castellón
country: Spain
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Alzira
country: Spain
facility: GSK Investigational Site
city: Artana/Castellón
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Benicassim (Castellon)
country: Spain
facility: GSK Investigational Site
city: Cadiz
country: Spain
facility: GSK Investigational Site
city: Castellón
country: Spain
facility: GSK Investigational Site
city: Cáceres
country: Spain
facility: GSK Investigational Site
city: Gerona
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: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Merida
country: Spain
facility: GSK Investigational Site
city: Móstoles/Madrid
country: Spain
facility: GSK Investigational Site
city: Onda (Castellon)
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: Sta Coloma de Gramanet (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Tarrasa, Barcelona
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: Emmenbrücke
country: Switzerland
facility: GSK Investigational Site
city: Gettnau
country: Switzerland
facility: GSK Investigational Site
city: Jegenstorf
country: Switzerland
facility: GSK Investigational Site
city: Lugano
country: Switzerland
facility: GSK Investigational Site
city: Luzern
country: Switzerland
facility: GSK Investigational Site
city: Pregassona
country: Switzerland
facility: GSK Investigational Site
city: Salmsach
country: Switzerland
facility: GSK Investigational Site
city: St. Maurice
country: Switzerland
facility: GSK Investigational Site
city: Steckborn
country: Switzerland
facility: GSK Investigational Site
city: Winterthur
country: Switzerland
facility: GSK Investigational Site
city: Winterthur
country: Switzerland
facility: GSK Investigational Site
city: Zürich
country: Switzerland
facility: GSK Investigational Site
city: Zürich
country: Switzerland
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Blackpool
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Bath
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Leeds
country: United Kingdom
facility: GSK Investigational Site
city: Sheffield
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, DM, FRCP
role: STUDY_DIRECTOR
References: