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

August 31, 2016 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

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

  • Austria
      • Vienna, Austria, A-1030
        • GSK Investigational Site
      • Vienna, Austria, A-1060
        • GSK Investigational Site
  • France
      • Angers, France, 49000
        • GSK Investigational Site
      • Bondy Cedex, France, 93143
        • GSK Investigational Site
      • Cholet, France, 49300
        • GSK Investigational Site
      • Corbeil Essonnes Cedex, France, 91106
        • GSK Investigational Site
      • Douai Cedex, France, 59507
        • GSK Investigational Site
      • Epinay sur Orge, France, 91360
        • GSK Investigational Site
      • La Rochelle Cedex 1, France, 17019
        • GSK Investigational Site
      • Lorient, France, 56322
        • GSK Investigational Site
      • Lyon Cedex 03, France, 69394
        • GSK Investigational Site
      • Montbrison, France, 42600
        • GSK Investigational Site
      • Nantes Cedex 1, France, 44093
        • GSK Investigational Site
      • Paris, France, 75015
        • GSK Investigational Site
      • Pierre Benite Cedex, France, 69495
        • GSK Investigational Site
      • Reims Cedex, France, 51092
        • GSK Investigational Site
      • Rennes Cedex 2, France, 35203
        • GSK Investigational Site
      • Saint Malo Cedex, France, 35403
        • GSK Investigational Site
      • Toul Cedex, France, 54201
        • GSK Investigational Site
      • Venissieux, France, 69200
        • GSK Investigational Site
    • Nord-Pas-de-Calais
      • Roubaix, Nord-Pas-de-Calais, France, 59100
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10789
        • GSK Investigational Site
      • Berlin, Germany, 12351
        • GSK Investigational Site
      • Berlin, Germany, 13057
        • GSK Investigational Site
      • Berlin, Germany, 12347
        • GSK Investigational Site
      • Hamburg, Germany, 20246
        • GSK Investigational Site
      • Hamburg, Germany, 22041
        • GSK Investigational Site
      • Hamburg, Germany, 22607
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Hermaringen, Baden-Wuerttemberg, Germany, 89568
        • GSK Investigational Site
      • Kippenheim, Baden-Wuerttemberg, Germany, 77971
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Germany, 68161
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Germany, 68199
        • GSK Investigational Site
      • Sinsheim, Baden-Wuerttemberg, Germany, 74889
        • GSK Investigational Site
      • Stockach, Baden-Wuerttemberg, Germany, 78333
        • GSK Investigational Site
    • Bayern
      • Ilvesheim, Bayern, Germany, 68549
        • GSK Investigational Site
      • Kuenzing, Bayern, Germany, 94550
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80469
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81373
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81549
        • GSK Investigational Site
      • Wallerfing, Bayern, Germany, 94574
        • GSK Investigational Site
    • Brandenburg
      • Falkensee, Brandenburg, Germany, 14612
        • GSK Investigational Site
      • Potsdam, Brandenburg, Germany, 14467
        • GSK Investigational Site
      • Schwedt, Brandenburg, Germany, 16303
        • GSK Investigational Site
    • Hessen
      • Bad Kreuznach, Hessen, Germany, 55545
        • GSK Investigational Site
      • Frankfurt, Hessen, Germany, 60326
        • GSK Investigational Site
      • Schluechtern, Hessen, Germany, 36381
        • GSK Investigational Site
      • Vellmar, Hessen, Germany, 34246
        • GSK Investigational Site
    • Niedersachsen
      • Hildesheim, Niedersachsen, Germany, 31139
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52070
        • GSK Investigational Site
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
        • GSK Investigational Site
      • Beckum, Nordrhein-Westfalen, Germany, 59269
        • GSK Investigational Site
      • Dortmund, Nordrhein-Westfalen, Germany, 44137
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, Germany, 47574
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51069
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51065
        • GSK Investigational Site
      • Neuss, Nordrhein-Westfalen, Germany, 41466
        • GSK Investigational Site
      • Viersen, Nordrhein-Westfalen, Germany, 41751
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Altenkirchen, Rheinland-Pfalz, Germany, 57610
        • GSK Investigational Site
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67061
        • GSK Investigational Site
      • Rhaunen, Rheinland-Pfalz, Germany, 55624
        • GSK Investigational Site
      • Simmern, Rheinland-Pfalz, Germany, 55469
        • GSK Investigational Site
      • Speyer, Rheinland-Pfalz, Germany, 67346
        • GSK Investigational Site
    • Saarland
      • Saarlouis, Saarland, Germany, 66740
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
      • Dresden, Sachsen, Germany, 01219
        • GSK Investigational Site
      • Freital, Sachsen, Germany, 01705
        • GSK Investigational Site
      • Pirna, Sachsen, Germany, 01796
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Halberstadt, Sachsen-Anhalt, Germany, 38820
        • GSK Investigational Site
      • Halle, Sachsen-Anhalt, Germany, 06112
        • GSK Investigational Site
      • Halle, Sachsen-Anhalt, Germany, 06114
        • GSK Investigational Site
    • Thueringen
      • Gotha, Thueringen, Germany, 99867
        • GSK Investigational Site
      • Schleiz, Thueringen, Germany, 07907
        • GSK Investigational Site
  • Italy
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italy, 43100
        • GSK Investigational Site
    • Friuli-Venezia-Giulia
      • Pordenone, Friuli-Venezia-Giulia, Italy, 33170
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
    • Umbria
      • Perugia, Umbria, Italy, 06126
        • GSK Investigational Site
    • Veneto
      • Padova, Veneto, Italy, 35128
        • GSK Investigational Site
      • Treviso, Veneto, Italy, 31100
        • GSK Investigational Site
  • Spain
      • Alcobendas/Madrid, Spain, 28100
        • GSK Investigational Site
      • Alicante, Spain
        • GSK Investigational Site
      • Barcelona, Spain, 08036
        • GSK Investigational Site
      • Barcelona, Spain, 08022
        • GSK Investigational Site
      • Cadiz, Spain, 11009
        • GSK Investigational Site
      • Galdakano, Spain, 48960
        • GSK Investigational Site
      • Granada, Spain, 18012
        • GSK Investigational Site
      • Madrid, Spain, 28006
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Móstoles/Madrid, Spain, 28935
        • 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
      • Valencia, Spain, 46010
        • GSK Investigational Site
      • Vigo/Pontevedra, Spain, 36200
        • 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Rosiglitazone/metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HbA1c
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

October 1, 2003

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

October 1, 2003

First Submitted That Met QC Criteria

October 2, 2003

First Posted (Estimate)

October 3, 2003

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 712753/009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: 712753/009
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: 712753/009
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: 712753/009
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: 712753/009
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistical Analysis Plan
    Information identifier: 712753/009
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: 712753/009
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: 712753/009
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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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