Use of Beta-blockers and Risk of New Onset Diabetes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01587638

Enrollment

12336

Registered

2012-04-30

Start date

2009-04-30

Completion date

2009-12-31

Last updated

2012-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

new-onset diabetes, carvedilol, claims analysis, beta-blocker, Diabetes Mellitus

Brief 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.

Interventions

DRUGcarvedilol

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

DRUGcardio selective betablocker

atenolol, metoprolol succinate, and metoprolol tartrate

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of New Onset Diabetes (NOD)	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)	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026