Last updated: 11/03/2018 11:29:02
Use of Beta-blockers and risk of new onset diabetes
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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