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

Sponsor
Boehringer Ingelheim
Study ID
NCT04937816
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo
  • Empagliflozin — DRUG
    Empagliflozin once daily

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Jun 2023
Primary completion
Jul 13, 2021
Completion
Jul 13, 2021

Study Design

Enrollment
16,746 participants (actual)

Arms

  • Arm: EMPA-REG - Placebo
    Participants of the EMP-REG OUTCOME study (1245.25) who received placebo.
  • Arm: EMPA-REG - Empagliflozin low dose
    Participants of the EMPA-REG OUTCOME study (1245.25) who received a low dose of empagliflozin once daily (QD).
  • Arm: EMPA-REG - Empagliflozin high dose
    Participants of the EMP-REG OUTCOME study (1245.25) who received a high dose of empagliflozin once daily (QD).
  • Arm: EMPEROR-Preserved - Empagliflozin
    Participants of the EMPEROR-Preserved study (1245.110) who received empagliflozin once daily (QD).
  • Arm: EMPEROR-Preserved - Placebo
    Participants of the EMPEROR-Preserved study (1245.110) who received placebo once daily (QD).
  • Arm: EMPEROR-Reduced - Empagliflozin
    Participants of the EMPEROR-Reduced study (1245.121) who received empagliflozin once daily (QD).
  • Arm: EMPEROR-Reduced - Placebo
    Participants of the EMPEROR-Reduced study (1245.121) who received placebo once daily (QD).

Primary Outcome Measure

Incidence Rate of Lower Limb Amputation (LLA) [ Time Frame: From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days. ]

Related Studies