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

May 15, 2009 updated by: GlaxoSmithKline

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

544

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • GSK Investigational Site
      • Bruxelles, Belgium, 1030
        • GSK Investigational Site
      • Bruxelles, Belgium, 1210
        • GSK Investigational Site
      • Heverlee, Belgium, 3001
        • GSK Investigational Site
      • Landen, Belgium, 3400
        • GSK Investigational Site
      • Namur (Champion), Belgium, 5020
        • GSK Investigational Site
      • Oostham, Belgium, 3945
        • GSK Investigational Site
      • Petit-Rechain, Belgium, 4800
        • GSK Investigational Site
      • Tessenderlo, Belgium, 3980
        • GSK Investigational Site
      • Tremelo, Belgium, 3120
        • GSK Investigational Site
      • Willebroek, Belgium, 2830
        • GSK Investigational Site
      • Zandhoven (Pulle), Belgium, 2243
        • GSK Investigational Site
  • France
      • Anzin, France, 59410
        • GSK Investigational Site
      • Briollay, France, 49125
        • GSK Investigational Site
      • Commelle Vernay, France, 42120
        • GSK Investigational Site
      • Cremeaux, France, 42260
        • GSK Investigational Site
      • Evron, France, 53600
        • GSK Investigational Site
      • Laval, France, 53000
        • GSK Investigational Site
      • Louverne, France, 53950
        • GSK Investigational Site
      • Lyon, France, 69007
        • GSK Investigational Site
      • Paris, France, 75015
        • GSK Investigational Site
      • Roanne, France, 42300
        • GSK Investigational Site
      • Saint Ouen, France, 93400
        • GSK Investigational Site
      • Sainte Suzanne, France, 53270
        • GSK Investigational Site
      • Segré, France, 49500
        • GSK Investigational Site
      • Venissieux, France, 69200
        • GSK Investigational Site
    • Nord-Pas-de-Calais
      • Roubaix, Nord-Pas-de-Calais, France, 59100
        • GSK Investigational Site
  • Germany
    • Baden-Wuerttemberg
      • Gueglingen, Baden-Wuerttemberg, Germany, 74363
        • GSK Investigational Site
      • Kippenheim, Baden-Wuerttemberg, Germany, 77971
        • GSK Investigational Site
      • Koenigsfeld, Baden-Wuerttemberg, Germany, 78126
        • GSK Investigational Site
      • Waldshut-Tiengen, Baden-Wuerttemberg, Germany, 79961
        • GSK Investigational Site
      • Weinheim, Baden-Wuerttemberg, Germany, 69469
        • GSK Investigational Site
    • Bayern
      • Grafing, Bayern, Germany, 85567
        • GSK Investigational Site
      • Herzogenaurach, Bayern, Germany, 91074
        • GSK Investigational Site
      • Immenstadt, Bayern, Germany, 87509
        • GSK Investigational Site
      • Oberteisendorf, Bayern, Germany, 83317
        • GSK Investigational Site
      • Saaldorf-Surheim, Bayern, Germany, 83416
        • GSK Investigational Site
      • Wallerfing, Bayern, Germany, 94574
        • GSK Investigational Site
      • Wuerzburg, Bayern, Germany, 97072
        • GSK Investigational Site
    • Hessen
      • Grossalmerode, Hessen, Germany, 37247
        • GSK Investigational Site
    • Niedersachsen
      • Einbeck, Niedersachsen, Germany, 37574
        • GSK Investigational Site
      • Hannover, Niedersachsen, Germany, 30519
        • GSK Investigational Site
      • Isernhagen, Niedersachsen, Germany, 30916
        • GSK Investigational Site
      • Papenburg, Niedersachsen, Germany, 26871
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Beckum, Nordrhein-Westfalen, Germany, 59269
        • GSK Investigational Site
      • Bergkamen-Rünthe, Nordrhein-Westfalen, Germany, 59192
        • GSK Investigational Site
      • Bochum, Nordrhein-Westfalen, Germany, 44869
        • GSK Investigational Site
      • Dinslaken, Nordrhein-Westfalen, Germany, 46537
        • GSK Investigational Site
      • Dortmund, Nordrhein-Westfalen, Germany, 44137
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45359
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45134
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, Germany, 47574
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51069
        • GSK Investigational Site
      • Viersen, Nordrhein-Westfalen, Germany, 41749
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • GSK Investigational Site
      • Neuwied, Rheinland-Pfalz, Germany, 56564
        • GSK Investigational Site
      • Rhaunen, Rheinland-Pfalz, Germany, 55624
        • GSK Investigational Site
      • Speyer, Rheinland-Pfalz, Germany, 67346
        • GSK Investigational Site
    • Saarland
      • Saarlouis, Saarland, Germany, 66740
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01219
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Wolmirstedt, Sachsen-Anhalt, Germany, 39326
        • GSK Investigational Site
    • Schleswig-Holstein
      • Elmshorn, Schleswig-Holstein, Germany, 25335
        • GSK Investigational Site
  • Ireland
      • Blanchardstown, Ireland, 15
        • GSK Investigational Site
      • Dublin, Ireland, 8
        • GSK Investigational Site
      • Dublin, Ireland, 9
        • GSK Investigational Site
  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • GSK Investigational Site
      • Ferrara, Emilia-Romagna, Italy, 44100
        • GSK Investigational Site
      • Ravenna, Emilia-Romagna, Italy, 48100
        • GSK Investigational Site
    • Liguria
      • Arenzano (GE), Liguria, Italy, 16011
        • GSK Investigational Site
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
    • Sardegna
      • Sassari, Sardegna, Italy, 07100
        • GSK Investigational Site
    • Umbria
      • Città di Castello (PG), Umbria, Italy, 06012
        • GSK Investigational Site
      • Terni, Umbria, Italy, 05100
        • GSK Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-44320
        • GSK Investigational Site
      • Kaunas, Lithuania, LT-49335
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08661
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-07156
        • GSK Investigational Site
  • Mexico
      • Durango, Mexico, 3400
        • GSK Investigational Site
      • Mexico, D.F., Mexico, 11850
        • GSK Investigational Site
    • Baja California Norte
      • Tijuana, Baja California Norte, Mexico, 22320
        • GSK Investigational Site
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42039
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • GSK Investigational Site
  • Netherlands
      • Beek En Donk, Netherlands, 5741 CG
        • GSK Investigational Site
      • Beerzerveld, Netherlands, 7685 PG
        • GSK Investigational Site
      • Den Haag, Netherlands, 2582 LJ
        • GSK Investigational Site
      • Heerlen, Netherlands, 6416 EG
        • GSK Investigational Site
      • Hoogvliet, Netherlands, 3192 JN
        • GSK Investigational Site
      • Landgraaf, Netherlands, 6373 JS
        • GSK Investigational Site
      • Musselkanaal, Netherlands, 9581 AJ
        • GSK Investigational Site
      • Oude Pekela, Netherlands, 9665 AR
        • GSK Investigational Site
      • Spijkenisse, Netherlands, 3207 NB
        • GSK Investigational Site
      • Woerden, Netherlands, 3443 GG
        • GSK Investigational Site
      • Zaandam, Netherlands, 1504 JA
        • GSK Investigational Site
      • Zieuwent, Netherlands, 7136 KH
        • GSK Investigational Site
  • Spain
      • Alcobendas/Madrid, Spain, 28100
        • GSK Investigational Site
      • Alcora/Castellón, Spain, 12110
        • GSK Investigational Site
      • Alicante, Spain
        • GSK Investigational Site
      • Alzira, Spain, 46600
        • GSK Investigational Site
      • Artana/Castellón, Spain, 12527
        • GSK Investigational Site
      • Barcelona, Spain, 08022
        • GSK Investigational Site
      • Barcelona, Spain, 08015
        • GSK Investigational Site
      • Benicassim (Castellon), Spain
        • GSK Investigational Site
      • Cadiz, Spain, 11009
        • GSK Investigational Site
      • Castellón, Spain
        • GSK Investigational Site
      • Cáceres, Spain, 10004
        • GSK Investigational Site
      • Gerona, Spain
        • GSK Investigational Site
      • Granada, Spain, 18014
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Madrid, Spain, 28037
        • GSK Investigational Site
      • Malaga, Spain, 29009
        • GSK Investigational Site
      • Merida, Spain, 6800
        • GSK Investigational Site
      • Móstoles/Madrid, Spain, 28935
        • GSK Investigational Site
      • Onda (Castellon), Spain
        • 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
      • Sta Coloma de Gramanet (Barcelona), Spain, 08923
        • GSK Investigational Site
      • Tarrasa, Barcelona, Spain, 08221
        • GSK Investigational Site
      • Valencia, Spain, 46010
        • GSK Investigational Site
  • Switzerland
      • Bern, Switzerland, 3007
        • GSK Investigational Site
      • Emmenbrücke, Switzerland, 6020
        • GSK Investigational Site
      • Gettnau, Switzerland, 6142
        • GSK Investigational Site
      • Jegenstorf, Switzerland, 3303
        • GSK Investigational Site
      • Lugano, Switzerland, 6900
        • GSK Investigational Site
      • Luzern, Switzerland, 6004
        • GSK Investigational Site
      • Pregassona, Switzerland, 6963
        • GSK Investigational Site
      • Salmsach, Switzerland, 8599
        • GSK Investigational Site
      • St. Maurice, Switzerland, 1890
        • GSK Investigational Site
      • Steckborn, Switzerland, 8266
        • GSK Investigational Site
      • Winterthur, Switzerland, 8400
        • GSK Investigational Site
      • Winterthur, Switzerland, 8405
        • GSK Investigational Site
      • Zürich, Switzerland, 8046
        • GSK Investigational Site
      • Zürich, Switzerland, 8050
        • GSK Investigational Site
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • GSK Investigational Site
      • Leeds, United Kingdom, LS12 1JE
        • GSK Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G3 8YJ
        • GSK Investigational Site
      • Glasgow, Lanarkshire, United Kingdom, G69 7AD
        • GSK Investigational Site
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY4 3AD
        • GSK Investigational Site
    • Somerset
      • Bath, Somerset, United Kingdom, BA1 3NG
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in HbA1c level from baseline following 52 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
CRP
insulin sensitivity
beta cell function
Change in FPG (fasting plasma glucose)
change in PAI-1
number of hypoglycaemic events
Change in 24 hr ABPM
Diabetes treatment satisfaction.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, DM, FRCP, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 31, 2006

First Posted (Estimate)

August 1, 2006

Study Record Updates

Last Update Posted (Estimate)

May 18, 2009

Last Update Submitted That Met QC Criteria

May 15, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVM100264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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