NCT03817463

Brief Summary

Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
327,624

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
11 countries

13 active sites

Status
completed

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

January 24, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

September 23, 2024

Completed
Last Updated

September 23, 2024

Status Verified

May 1, 2024

Enrollment Period

2.7 years

First QC Date

January 24, 2019

Results QC Date

December 8, 2022

Last Update Submit

May 28, 2024

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (8)

  • Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition

    Number of participants with Hospitalization for Heart Failure (HHF), using broad + specific HHF definition. HHF - broad defined as any diagnosis associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters, or dispensation or any other record of the high-ceiling diuretics (loop diuretics). HHF - specific defined as a primary diagnosis associated with hospital admission. For HHF - broad + specific, HHF-specific definition was used unless only broad definition were available. However, for Japan South Korea and Taiwan, both definitions were available, but broad definition was used.

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i

  • Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition

    Reported is the number of participants with hospitalization for heart failure (HHF), using broad definition of HHF. HHF - broad is defined as any diagnosis associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters, or dispensation or any other record of the high-ceiling diuretics (loop diuretics).

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i

  • Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition

    Reported is the number of participants with hospitalization for heart failure, using specific definition for HHF. HHF - specific defined as a primary diagnosis associated with hospital admission.

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i

  • Number of Participants With All-cause Mortality (ACM)

    Number of participants with all-cause mortality (ACM).

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.

  • Number of Participants With Composite Outcome, Including Hospitalization for Heart Failure (HHF) and All Cause Mortality (ACM)

    Number of participants with composite outcome, including hospitalization for heart failure (HHF) and all cause mortality (ACM).

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.

  • Number of Participants With Composite Outcome, Including Myocardial Infraction (MI), Stroke and All Cause Mortality (ACM)

    Number of participants with composite outcome, including myocardial infraction (MI), stroke and all cause mortality (ACM).

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.

  • Number of Participants With Myocardial Infarction (MI)

    Number of participants with myocardial infarction (MI).

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.

  • Number of Participants With Stroke

    Number of participants with stroke.

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.

Secondary Outcomes (19)

  • Number of Participants With Cardiovascular Mortality (CM)

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.

  • Number of Participants With Composite Outcome Including Hospitalization for Heart Failure (HHF) and Cardiovascular (CV) Mortality

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.

  • Number of Participants With 3-point Major Adverse Cardiovascular (CV) Events (MACE), Defined as a Composite Outcome Including Myocardial Infarction (MI), Stroke and Cardiovascular (CV) Mortality

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.

  • Number of Participants With Coronary Revascularization Procedure

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.

  • Number of Participants With End-stage Renal Disease (ESRD)

    From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.

  • +14 more secondary outcomes

Study Arms (2)

New users of SGLT-2i

Patients with type 2 diabetes mellitus (T2DM), who were new users of any sodium-glucose cotransporter-2 inhibitors (SGLT-2i) including empagliflozin.

Drug: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor

New users of DPP-4i

Patients with type 2 diabetes mellitus (T2DM), who were new users of dipeptidyl peptidase-4 inhibitors (DPP-4i).

Drug: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor

Interventions

Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitorDRUG

Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor

New users of SGLT-2i
Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitorDRUG

Dipeptidyl peptidase-4 (DPP-4) inhibitor

New users of DPP-4i

Eligibility Criteria

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

This will be a non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of T2DM. All data will be obtained from electronically recorded longitudinal secondary data sources, separately in each included country. In each country, patients initiating treatment with empagliflozin or any other SGLT-2 inhibitor will be compared with PS-matched patients initiating treatment with any DPP-4inhibitor.

You may qualify if:

  • Dispensation or any other record of empagliflozin, any SGLT-2 inhibitor, or any DPP-4 inhibitor use during the study period
  • No dispensation or any other record of any other SGLT-2 inhibitor or DPP-4 inhibitor use during the preceding 12 months including at index date
  • Having a diagnosis of T2DM before the index date, based on ICD-10 codes or other available data

You may not qualify if:

  • Aged \<18 years on the first dispensation date or date of the first record of empagliflozin, any SGLT-2 inhibitor or any DPP-4 inhibitor use
  • Type 1 diabetes mellitus
  • Secondary diabetes
  • Gestational diabetes
  • Having a diagnosis of ESRD during the 12 months before the index date
  • \<12 months of available data before the index date, and/or no complete history of drug dispensations/other records of the drug use during this period
  • Missing or ambiguous data on age or sex

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology

Gentofte Municipality, 2820, Denmark

Location

Helsinki University Hospital

Helsinki, 00029, Finland

Location

University of Ulm, Institute for Epidemiology and medical biometry

Ulm, 89081, Germany

Location

Maccabi Healthcare Services

Tel Aviv, 6812509, Israel

Location

Gifu University

Gifu, 501-1193, Japan

Location

Oslo University Hospital, Department of Clinical Lipidology

Oslo, 0424, Norway

Location

Oslo University Hospital, Department of Cardiology

Oslo, 0450, Norway

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Instituto de Investigación Sanitaria INCLIVA

Valencia, 46010, Spain

Location

TFS Trial Form Support International AB

Lund, 223 63, Sweden

Location

Quantify Research AB

Stockholm, 112 21, Sweden

Location

Taiwan Society for Pharmacoeconomics and Outcome Research (TaSPOR)

Taipei, 100, Taiwan

Location

Leicester Real World Evidence Unit, Leicester general Hospital

Leicester, LE5 4PW, United Kingdom

Location

Related Publications (1)

  • Nystrom T, Toresson Grip E, Gunnarsson J, Casajust P, Karlsdotter K, Skogsberg J, Ustyugova A; EMPRISE Study Group. Empagliflozin reduces cardiorenal events, healthcare resource use and mortality in Sweden compared to dipeptidyl peptidase-4 inhibitors: Real world evidence from the Nordic EMPRISE study. Diabetes Obes Metab. 2023 Jan;25(1):261-271. doi: 10.1111/dom.14870. Epub 2022 Oct 10.

    PMID: 36097728DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozinSodium-Glucose Transporter 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sodium-Glucose Transport ProteinsSymportersIon PumpsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMonosaccharide Transport ProteinsSolute Carrier ProteinsMembrane Proteins

Results Point of Contact

Title
Boehringer Ingelheim, Call Centre
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Kimberly G Brodovicz, (203) 448-1937

    kimberly.brodovicz@boehringer-ingelheim.com

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 25, 2019

Study Start

April 15, 2019

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

September 23, 2024

Results First Posted

September 23, 2024

Record last verified: 2024-05

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

JP(1)DE(1)KR(1)ES(1)TW(1)GB(1)FI(1)DK(1)IL(1)NO(2)SE(2)