Status:
ACTIVE_NOT_RECRUITING
Comparative Effectiveness of Empagliflozin in the US
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients \>= 18 years old for Marketscan and Optum, and \>=65 years old for Medicare only
- Patients initiating empagliflozin or a DPP-4 inhibitor within the study period. Initiation was defined as no use of SGLT-2 inhibitors (canagliflozin, dapagliflozin, ertugliflozin) or DPP-4 inhibitors in the previous 12 months.
- Restriction to patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or 250.x2; ICD-10 Dx code of E11.x) in the 12 months prior to drug initiation.
- Exclusion criteria:
- Patients with missing or ambiguous age or sex information.
- All patients who have less than 12 months of continuous registration in the database prior to initiation of empagliflozin or a DPP-4 inhibitor will be excluded.
- Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient codes in the 12 months prior to drug initiation.
- Secondary diabetes, and gestational diabetes in the 12 months prior to drug initiation
- History of cancer in the 5 years prior to drug initiation
- End-stage renal disease (ESRD) in the 12 months prior to drug initiation
- HIV diagnosis or treatment in the 12 months prior to drug initiation
- Organ transplant in the 12 months prior to drug initiation
- Patients that were in nursing homes in the 12 months prior to drug initiation
- Patients with concomitant SGLT-2 inhibitor and DPP-4 inhibitor initiation will also be excluded.
- Patients initiating more than one DPP-4i on cohort entry date will additionally be excluded Additional exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
October 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
230000 Patients enrolled
Trial Details
Trial ID
NCT03363464
Start Date
October 16 2017
End Date
December 31 2025
Last Update
April 15 2025
Active Locations (1)
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1
Bringham Women Hospital
Boston, Massachusetts, United States, 02120