Status:
COMPLETED
A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 10 2021
Estimated Enrollment :
327624 Patients enrolled
Trial Details
Trial ID
NCT03817463
Start Date
April 15 2019
End Date
December 10 2021
Last Update
September 23 2024
Active Locations (13)
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1
Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology
Gentofte Municipality, 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