Last updated: 11/03/2018 11:29:02

Use of Beta-blockers and risk of new onset diabetes

GSK study ID
111198
See study documents
Clinicaltrials.gov ID
NCT01587638
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: Use of Beta-blockers and risk of new onset diabetes
Trial description: This study used an observational, retrospective cohort design to compare the presence and timing of new-onset diabetes (NOD) between hypertensive patients initiating therapy with carvedilol immediate-release (IR) and carvedilol controlled-release (CR) vs the following cardioselective beta blockers (BBs): atenolol, metoprolol succinate, and metoprolol tartrate (referred to hereafter as ‘other BB’).
The aim of the study was to investigate the likelihood of developing NOD among hypertensive patients initiating carvedilol therapy vs other BB therapy in a real world setting derived from data contained in a large United States (US) managed care database.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Rate of New Onset Diabetes (NOD)

Timeframe: From index event (BB prescription) to NOD outcome event (DM diagnosis or antidiabetic Rx) during the effective dates of the database (up to 7 years)

Secondary outcomes:
Not applicable
Interventions:
  • Drug: carvedilol
  • Drug: cardio selective betablocker
    • Enrollment:
    12336
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Fonseca V, Sharma P, Shah M, Deedwania P. Risk of New Onset Diabetes Mellitus Associated with Beta Blocker Treatment for Hypertension. Curr Med Res Opin 2011; 27:799–807
    Fonseca V, Sharma P, Shah M, Deedwania P. Risk of New Onset Diabetes Mellitus Associated with Beta Blocker Treatment for Hypertension. Curr Med Res Opin 2011; 27:799–807
    Medical condition
    Hypertension
    Product
    carvedilol
    Collaborators
    Not applicable
    Study date(s)
    April 2009 to November 2009
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Enrollment in a plan captured in the IMS LifeLink Health Plan Claims Database between July 1, 2000 and December 31, 2007
    • aged ≥18 years
    • Diagnosis of diabetes mellitus (ICD-9-CM: 250.xx) and/or a prescription for antidiabetic therapy in the 6 months prior to and/or 3 months after the index date
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Enrollment in a plan captured in the IMS LifeLink Health Plan Claims Database between July 1, 2000 and December 31, 2007
    • aged ≥18 years
    • at least one pharmacy claim for a beta-blocker of interest (carvedilol immediate-release [IR]/controlled-release [CR], atenolol, metoprolol succinate, or metoprolol tartrate)
    • Index date was the first chronologically occurring prescription for any beta-blocker during the enrollment period
    • Continuously eligible to receive healthcare services 6 months prior to and 3 months after the index date
    • at least 1 diagnosis of hypertension (International Classification of Disease, 9th Revision, Clinical Modification (ICD-9-CM): 401.xx–405.xx) during this time frame.
    Exclusion criteria:
    • Diagnosis of diabetes mellitus (ICD-9-CM: 250.xx) and/or a prescription for antidiabetic therapy in the 6 months prior to and/or 3 months after the index date

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2009-01-11

    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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