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
- Study ID
- NCT03817463
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor — DRUGEmpagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
- Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor — DRUGDipeptidyl peptidase-4 (DPP-4) inhibitor
Study Details
Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.
Key Dates
- Start date
- Apr 15, 2019
- Status verified
- May 2024
- Primary completion
- Dec 10, 2021
- Completion
- Dec 10, 2021
Study Design
- Enrollment
- 327,624 participants (actual)
Arms
- Arm: New users of SGLT-2iPatients with type 2 diabetes mellitus (T2DM), who were new users of any sodium-glucose cotransporter-2 inhibitors (SGLT-2i) including empagliflozin.
- Arm: New users of DPP-4iPatients with type 2 diabetes mellitus (T2DM), who were new users of dipeptidyl peptidase-4 inhibitors (DPP-4i).
Primary Outcome Measure
Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition [ Time Frame: 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 ]
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