Last updated: 11/03/2018 17:15:54

Malignancy meta analysis for BRL49653

GSK study ID
114769
See study documents
Clinicaltrials.gov ID
NCT01195259
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 Meta Analysis of malignancy serious adverse events in the ADOPT, 49653/048, and RECORD, 49653/231, studies, comparing metformin with rosiglitazone.
Trial description: Observational analyses of data from population registeries have suggested that metformin may be associated with a decreased prevalence of malignancy. The ADOPT and RECORD studies both contain groups of subjects randomly allocated to metformin and rosiglitazone. This meta-analysis combines malignancy serious adverse events from ADOPT and RECORD in order to compare their incidence on metformin with that on rosiglitazone.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Time to first occurrence of a serious adverse event of malignancy (excluding non-melanomatous skin cancers)

Timeframe: ADOPT approximately 4 years duration, RECORD approximately 5.5 years duration

Secondary outcomes:
Not applicable
Interventions:
  • Drug: allocation of treatment with metformin or rosiglitazone
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Home PD, Kahn SE, Jones NP, Noronha D, Beck-Nielsen H, Viberti G; ADOPT Study Group; RECORD Steering Committee.. Experience of malignancies with oral glucose-lowering drugs in the randomised controlled ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) clinical trials. [Diabetologia]. 2010;53(9):1838-1845.
    Home PD, Kahn SE, Jones NP, Noronha D, Beck-Nielsen H, Viberti G; ADOPT Study Group; RECORD Steering Committee.. Experience of malignancies with oral glucose-lowering drugs in the randomised controlled ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) clinical trials. Diabetologia. 2010;53(9):1838-1845.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    October 2009 to January 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Subjects from ADOPT that are included in this meta-analysis (those in the metformin or rosiglitazone groups) had the dose of their study medication increased to a maximum of 2g (metformin) or 8mg (rosiglitazone) if their fasting plasma glucose was greater than 140mg/dl.
    • Subjects from RECORD that are included in this meta-analsyis entered the RECORD study taking one of three sulfonylureas (glibenclamide, gliclazide or glimepiride). They were randomly allocated to metformin or rosiglitazone in a 1:1 ration to use as add-on treatment to the background of sulfonylurea. These subjects had the dose of their study medication increased to a maximum of 2.55g (metformin) or 8mg (rosiglitazone) if their HbA1c was greater than 7.0%.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects from ADOPT that are included in this meta-analysis (those in the metformin or rosiglitazone groups) had the dose of their study medication increased to a maximum of 2g (metformin) or 8mg (rosiglitazone) if their fasting plasma glucose was greater than 140mg/dl. Subjects from RECORD that are included in this meta-analsyis entered the RECORD study taking one of three sulfonylureas (glibenclamide, gliclazide or glimepiride). They were randomly allocated to metformin or rosiglitazone in a 1:1 ration to use as add-on treatment to the background of sulfonylurea. These subjects had the dose of their study medication increased to a maximum of 2.55g (metformin) or 8mg (rosiglitazone) if their HbA1c was greater than 7.0%.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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