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CompletedNCT01587638Updated Apr 30, 2012

Use of Beta-blockers and Risk of New Onset Diabetes

An observational study in Hypertension, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-30.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
12,336
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Hypertension

Keywords

  • new-onset diabetes
  • carvedilol
  • claims analysis
  • beta-blocker
  • Diabetes Mellitus
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 12,336 is above the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This retrospective database study identified patients aged ≥18 years with at least one pharmacy claim for a beta-blocker of interest (carvedilol immediate-release [IR]/controlled-release [CR], atenolol, metoprolol succinate, or metoprolol tartrate) identified in the IMS LifeLink Health Plan Claims Database. Index date was the first chronologically occurring prescription for any beta-blocker during the enrollment period (July 1, 2000-December 31, 2007). Patients were identified if they were continuously eligible to receive healthcare services 6 months prior to and 3 months after the index date and at least 1 diagnosis of hypertension (ICD-9-CM: 401.xx-405.xx) during this time frame.

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

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
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Study design

Time perspective
Retrospective
Enrollment
12,336 participants (actual)

Groups and cohorts

  • Hypertensive users of Beta blocker

    Patients aged ≥18 years and at least 1 diagnosis of hypertension (ICD-9-CM: 401.xx-405.xx) during this time frame in a US Managed care population

    Drug: carvedilol · Drug: cardio selective betablocker

Interventions

  • Drugcarvedilol

    carvedilol immediate-release (IR) and carvedilol controlled-release (CR)

    Also known as: carvedilol immediate-release (IR) and carvedilol controlled-release

  • Drugcardio selective betablocker

    atenolol, metoprolol succinate, and metoprolol tartrate

    Also known as: atenolol, metoprolol succinate, and metoprolol tartrate

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What researchers measure

Primary outcomes

  1. Rate of New Onset Diabetes (NOD)

    Rate of NOD per 100 person years. NOD was defined as at least two medical claims with a Diabetes Mellitus diagnosis (ICD-9-CM: 250.xx) or a prescription fill of an antidiabetic medication

    Time frame: 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)

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Fonseca V, Sharma PP, Shah M, Deedwania P. Risk of new-onset diabetes mellitus associated with beta-blocker treatment for hypertension. Curr Med Res Opin. 2011 Apr;27(4):799-807. doi: 10.1185/03007995.2011.555477. Epub 2011 Feb 10. PubMed 21306286 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01587638
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 30, 2012
Start date
Apr 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Apr 30, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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