Trials / Completed
CompletedNCT04937816
This Study Combines Data From 3 Other Studies Testing Empagliflozin in Patients With Diabetes or With Chronic Heart Failure. The Study Looks at the Numbers of Patients Who Had Lower Limb Amputations
A Meta-Analysis of Amputation Risk in Empagliflozin Studies (1245.25, 1245.110, 1245.121)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 16,746 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this exploratory meta-analysis is to evaluate the frequencies, incidence rates, and hazard ratios of lower-limb amputation (LLA) events (primary outcome) and of adverse events related to amputation (secondary outcome) in patients treated with empagliflozin compared with placebo in the pooled population of the long-term studies 1245.25, 1245.110, and 1245.121 (SAF-M1), in the pooled population of studies 1245.110 and 1245.121 (SAFM2), and in each of the 3 studies separately.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo |
| DRUG | Empagliflozin | Empagliflozin once daily |
Timeline
- Start date
- 2021-06-01
- Primary completion
- 2021-07-13
- Completion
- 2021-07-13
- First posted
- 2021-06-24
- Last updated
- 2024-02-08
- Results posted
- 2024-02-08
Locations
1 site across 1 country: Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04937816. Inclusion in this directory is not an endorsement.