HypertensionNCT01587638
Use of Beta-blockers and Risk of New Onset Diabetes
An observational study of Hypertension, run by GlaxoSmithKline.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- carvedilol and cardio selective betablocker
- How many people
- 12,336 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
- Conditions
- Hypertension
- Being tested
- carvedilol, cardio selective betablocker
- Keywords
- new-onset diabetes, carvedilol, claims analysis, beta-blocker, Diabetes Mellitus
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carvedilolDrug
Also called carvedilol immediate-release (IR) and carvedilol controlled-release
carvedilol immediate-release (IR) and carvedilol controlled-release (CR)
cardio selective betablockerDrug
Also called atenolol, metoprolol succinate, and metoprolol tartrate
atenolol, metoprolol succinate, and metoprolol tartrate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: carvedilol; Drug: cardio selective betablocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 12,336 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587638
- Sponsor's protocol ID
- 111198
- Status last verified
- Apr 2012
- First submitted
- 14 Apr 2011
- Last updated
- 30 Apr 2012
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Beta-blockers and Risk of New Onset Diabetes
- ClinicalTrials.gov ID
- NCT01587638
- Acronym / sponsor ID
- 111198
- Conditions
- Hypertension
- Keywords
- new-onset diabetes, carvedilol, claims analysis, beta-blocker, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,336 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive users of Beta blocker | – | Drug: carvedilol, Drug: cardio selective betablockerPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carvedilolAlso: carvedilol immediate-release (IR) and carvedilol controlled-releasecarvedilol immediate-release (IR) and carvedilol controlled-release (CR) | Drug | Hypertensive users of Beta blocker |
| cardio selective betablockerAlso: atenolol, metoprolol succinate, and metoprolol tartrateatenolol, metoprolol succinate, and metoprolol tartrate | Drug | Hypertensive users of Beta blocker |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Results publication: PubMed 21306286Fonseca 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.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01587638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2012.