A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03817463
Collaborator
(none)
171,808
13
31.9
13216
414.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
  • Drug: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor

Study Design

Study Type:
Observational
Actual Enrollment :
171808 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multi-country Non-interventional Study on the Effectiveness of Empagliflozin in Adult Patients With Type 2 Diabetes in Europe and Asia.
Actual Study Start Date :
Apr 15, 2019
Actual Primary Completion Date :
Dec 10, 2021
Actual Study Completion Date :
Dec 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients with T2DM

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

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants hospitalized for heart failure [up to 4.5 years]

  2. Number of participants with all-cause mortality [up to 4.5 years]

  3. Number of participants with both hospitalization for heart failure and all cause mortality [up to 4.5 years]

  4. Number of participants with myocardial infraction (MI), stroke, all cause mortality [up to 4.5 years]

Secondary Outcome Measures

  1. Number of participants with Cardiovascular mortality [up to 4.5 years]

  2. Number of participants with a composite outcome including hospitalization for heart failure and cardiovascular (CV) mortality [up to 4.5 years]

  3. 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 [up to 4.5 years]

  4. Number of participants with coronary revascularization procedure [up to 4.5 years]

  5. Number of participants with end-stage renal disease (ESRD) [up to 4.5 years]

  6. Number of participants with estimated glomerular filtration rate (eGFR) decline [up to 4.5 years]

  7. Number of participants with progression from normoalbuminuria to micro- or macroalbuminuria [up to 4.5 years]

  8. Number of participants with a composite outcome including eGFR decline and progression to micro- or macroalbuminuria [up to 4.5 years]

  9. Number of participants with bone fracture [up to 4.5 years]

  10. Number of participants with diabetic ketoacidosis [up to 4.5 years]

  11. Number of participants with severe hypoglycemia [up to 4.5 years]

  12. Number of participants with lower-limb amputation [up to 4.5 years]

  13. Number of participants with acute kidney injury requiring dialysis [up to 4.5 years]

  14. Healthcare resource utilization [up to 4.5 years]

  15. Cost of care [up to 4.5 years]

    Costs of HCRU

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology Gentofte Denmark 2820
2 Helsinki University Hospital Helsinki Finland 00029
3 University of Ulm, Institute for Epidemiology and medical biometry Ulm Germany 89081
4 Maccabi Healthcare Services Tel Aviv Israel 6812509
5 Gifu University Gifu Japan 501-1193
6 Ajou University Hospital Suwon Korea, Republic of 16499
7 Oslo University Hospital, Department of Clinical Lipidology Oslo Norway 0424
8 Oslo University Hospital, Department of Cardiology Oslo Norway 0450
9 Instituto de Investigación Sanitaria INCLIVA Valencia Spain 46010
10 TFS Trial Form Support International AB Lund Sweden 223 63
11 Quantify Research AB Stockholm Sweden 112 21
12 Taiwan Society for Pharmacoeconomics and Outcome Research (TaSPOR) Taipei City Taiwan 100
13 Leicester Real World Evidence Unit, Leicester general Hospital Leicester United Kingdom LE5 4PW

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Kimberly G Brodovicz, (203) 448-1937, kimberly.brodovicz@boehringer-ingelheim.com

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03817463
Other Study ID Numbers:
  • 1245-0195
First Posted:
Jan 25, 2019
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2022