Last updated: 11/04/2018 04:07:54

Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a registered trademark of the GSK group of companies.

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GSK study ID
712753/009
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Clinicaltrials.gov ID
NCT00069836
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from baseline in HbA1c

Timeframe: 24 weeks

Secondary outcomes:

Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction

Timeframe: 24 weeks

Interventions:
  • Drug: Rosiglitazone/metformin
    • Enrollment:
    272
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Home P, Bailey C, Donaldson J, Chen H, Stewart M. 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. Diabetic Med 2007; 24. doi: 10.1111/j.1464-5491.2007.02141.x
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    metformin, rosiglitazone, rosiglitazone/metformin
    Collaborators
    Not applicable
    Study date(s)
    October 2003 to November 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • 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.
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Toul Cedex, France, 54201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dortmund, Nordrhein-Westfalen, Germany, 44137
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Padova, Veneto, Italy, 35128
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Barcelona, Spain, 08022
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Venissieux, France, 69200
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Granada, Spain, 18012
    Status
    Study Complete
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    Showing 1 - 6 of 93 Results

    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-16-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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