A Study Using Medical Records of Danish People With Type 2 Diabetes Comparing Empagliflozin and Liraglutide in the Occurrence of Serious Cardiovascular Disease

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03993132
Collaborator
(none)
30,000
Enrollment
1
Location
38
Anticipated Duration (Months)
789.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Non-interventional cohort study using existing data from comapring the new users of Empagliflozin to new users of Liraglutide.

Condition or DiseaseIntervention/TreatmentPhase

Study Design

Study Type:
Observational
Actual Enrollment :
30000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Cardiovascular Outcomes and Mortality in Danish Patients With Type 2 Diabetes Who Initiate Empagliflozin Versus Liraglutide as Second-line Therapy: A Danish Nationwide Comparative Effectiveness Study
Actual Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Patients with type 2 diabetes

Drug: Empagliflozin
new users (initiators) of Empagliflozin

Drug: Liraglutide
initiators of Liraglutide

Outcome Measures

Primary Outcome Measures

  1. Acute inpatient hospital admission with a diagnosis of HF and/or initiation of community prescription drug therapy with loop diuretics [Up to 3 years]

  2. Acute inpatient hospital admission with a diagnosis of HF and/or all-cause death [Up to 3 years]

  3. Major adverse cardiac events of heart failure/any cardiovascular outcome or death [Up to 3 years]

Secondary Outcome Measures

  1. All-cause acute inpatient hospital admissions or emergency room visit notleading to inpatient hospital admission [Up to 3 years]

  2. All-cause acute inpatient hospital admission [Up to 3 years]

  3. Acute hospital admission with HF [Up to 3 years]

  4. All-cause acute inpatient hospital admission or all-cause death [Up to 3 years]

  5. All-cause death [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
The empagliflozin-exposed population must also meet the following criteria:
  • Have at least one prescription for empagliflozin or fixed-dose combination of empagliflozin with another drug, with or without treatment with another glucose-lowering drug

  • Have no prior prescription/dispensing of SGLT2 inhibitors (including empagliflozin) alone or in fixed-dose combination during the 12 months prior to the index date

  • Have no prior prescription/dispensing of a GLP-1 receptor agonist alone or in fixeddose combination during the 12 months prior to the index date

The population exposed to liraglutide must meet the following criteria:
  • Have at least one prescription for liraglutide or a fixed-dose combination of liraglutide with another drug, with or without treatment with another glucose-lowering drug.

  • Have no prior prescription/dispensing of a GLP-1 receptor agonist alone or in fixeddose combination during the 12 months prior to the index date

  • Have no prior prescription/dispensing of SGLT2 inhibitors (including empagliflozin) alone or in fixed-dose combination during the 12 months prior to the index date

Exclusion Criteria:

Patients with type 1 diabetes T1D before the index date will not be included in the study.

Exclusion criteria by outcome of interest: Different exclusion criteria will be applied to generate sets of cohorts for the analysis of the different outcomes of interest.

In one main analysis, we will assess co-primary and secondary outcomes among all patients, regardless of a history of previous outcome events being present or not. In other words, we will allow a previous history of CVD events. We will adjust for the history of these events in the regression model rather than excluding patients with previous events (e.g. assess outcome rates of myocardial infarction in empagliflozine and liraglutide initiators while adjusting for previous history of myocardial infarction, unstable angina, or coronary revascularization).

In another main analysis of outcomes, we will exclude patients who had a specific outcome previously.

For example in the analysis of the primary heart failure outcome (heart failure admission or loop-diuretics), patients will not be included if a diagnosis of heart failure is recorded any time before or at the index date, or if a prescription for loop-diuretics has been filled within 12 months before or at the index date. For the secondary outcome of acute hospital admission with heart failure, we will include also patients with previous prescription for loop-diuretics, but exclude those with previous heart failure admission.

For analysis of stroke, patients will not be included if a diagnosis of stroke is recorded any time before or at the index date.

For analysis of myocardial infarction, unstable angina, or coronary revascularization, patients will not be included if any of these 3 major atherosclerotic cardiovascular events are recorded any time before or at the index date.

In additional analyses, other criteria will apply (To be discussed, RWT). Thus, an additional analysis will include also patients with previous outcome events, and adjust for the history of these events in the regression model rather than excluding them (e.g. assess outcome rates of myocardial infarction in empagliflozine and liraglutide initiators while adjusting for previous history of myocardial infarction, unstable angina, or coronary revascularization).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Department of Clinical Epidemiology - Aarhus UnversiteteshospitalAarhusDenmark8200

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03993132
Other Study ID Numbers:
  • 1245-0194
First Posted:
Jun 20, 2019
Last Update Posted:
Oct 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2021