Use of Beta-blockers and Risk of New Onset Diabetes
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ClinicalTrials.gov Identifier: NCT01587638 |
Recruitment Status :
Completed
First Posted : April 30, 2012
Last Update Posted : April 30, 2012
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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.
Condition or disease | Intervention/treatment |
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Hypertension | Drug: carvedilol Drug: cardio selective betablocker |
Study Type : | Observational |
Actual Enrollment : | 12336 participants |
Time Perspective: | Retrospective |
Official Title: | Use of Beta-blockers and Risk of New Onset Diabetes |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Group/Cohort | Intervention/treatment |
---|---|
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
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Drug: carvedilol
carvedilol immediate-release (IR) and carvedilol controlled-release (CR)
Other Name: carvedilol immediate-release (IR) and carvedilol controlled-release Drug: cardio selective betablocker atenolol, metoprolol succinate, and metoprolol tartrate
Other Names:
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- Rate of New Onset Diabetes (NOD) [ 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) ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587638
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Publications of Results:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01587638 History of Changes |
Other Study ID Numbers: |
111198 |
First Posted: | April 30, 2012 Key Record Dates |
Last Update Posted: | April 30, 2012 |
Last Verified: | April 2012 |
new-onset diabetes carvedilol claims analysis beta-blocker Diabetes Mellitus |
Atenolol Hypertension Vascular Diseases Cardiovascular Diseases Metoprolol Carvedilol Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antioxidants Protective Agents Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |