NCT05102071

Brief Summary

Evaluation of clinical outcomes (specifically cardiovascular outcomes like hospitalization for heart failure), and healthcare cost, and resource utilization, among patients on empagliflozin as an add-on therapy to metformin versus patients on sulfonylureas as an add-on therapy to metformin in patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

October 28, 2021

Last Update Submit

May 30, 2022

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Occurrence of first hospitalization for congestive heart failure (HHF)

    up to 5 years and 3 months

Secondary Outcomes (6)

  • Hospitalizations

    up to 5 years and 3 months

  • Emergency department (ED) visits

    up to 5 years and 3 months

  • Length of stay

    up to 5 years and 3 months

  • Number of filled drugs

    up to 5 years and 3 months

  • Outpatient visits

    up to 5 years and 3 months

  • +1 more secondary outcomes

Study Arms (2)

Treatment with empagliflozin

as add-on therapy with metformin

Drug: empagliflozinDrug: metformin

Treatment with a sulfonylurea

as add-on therapy with metformin

Drug: metforminDrug: sulfonylurea

Interventions

empagliflozinDRUG

empagliflozin

Treatment with empagliflozin
metforminDRUG

metformin

Treatment with a sulfonylureaTreatment with empagliflozin
sulfonylureaDRUG

sulfonylurea

Treatment with a sulfonylurea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).

You may qualify if:

  • Prevalent metformin use + initiation of empagliflozin OR prevalent metformin use + initiation of sulfonylurea
  • ≥18 years of age at index date during study observation
  • ≥1 inpatient and/or ≥ 2 outpatient claims denoting T2D diagnosis (in any position) in the 12 months prior to index date
  • ≥1 inpatient and/or ≥2 outpatient claims denoting CVD (in any position) diagnosis in the 12 months prior to index date
  • ≥2 months post-index date
  • ≥12 months of no exposure to T2D medications in the pre-index period (excluding metformin in both arms)
  • ≥12 months of continuous enrolment prior to index date

You may not qualify if:

  • Diagnosis of Type 1 Diabetes, secondary, or gestational diabetes in the 12 months prior to index date
  • Diagnosis of severe comorbidities including malignancy, end-stage renal disease, human immunodeficiency virus, Hepatitis C infection, or organ transplant in the 12 months prior to index date
  • Admission to nursing home in the 12 months prior to index date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boehringer Ingelheim Pharmaceuticals Inc

Ridgefield, Connecticut, 06879, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Interventions

empagliflozinMetforminSulfonylurea Compounds

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsUreaAmidesSulfonesSulfur Compounds
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 1, 2021

Study Start

November 1, 2021

Primary Completion

June 15, 2022

Study Completion

June 15, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Locations

US(1)