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CompletedNCT04937816Updated Feb 8, 2024Results posted

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

An observational study in Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-08.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
16,746
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 16,746 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with type 2 diabetes mellitus and increased cardiovascular risk (1245.25), patients with chronic heart failure with preserved ejection fraction (1245.110), and patients with chronic heart failure with reduced ejection fraction (1245.121), who were either treated with empagliflozin or placebo.

Eligibility criteria

Inclusion Criteria for 1245.25:

  • Age ≥18 years, diagnosis of type 2 diabetes mellitus (T2DM)
  • Drug-naïve or pretreated with any background therapy

  • Glycated haemoglobin (HbA1c) criteria

    • Patients who were drug-naïve: HbA1c of 7 to 10%
    • Patients with background therapy: HbA1c of 7 to 9%
  • Body mass index (BMI) ≤45 kg/m2

  • With high cardiovascular risk, defined as ≥1 of the following criteria

    • History of myocardial infarction (>2 months prior to enrollment)
    • Multi-vessel coronary artery disease: ≥2 major vessels or left main coronary artery
    • Single-vessel coronary artery disease with no scheduled revascularization/previously unsuccessful revascularization
    • Hospital discharge due to unstable angina pectoris (>2 months prior to enrollment)
    • History of stroke (>2 months prior to enrollment)
    • Peripheral occlusive arterial disease

Inclusion criteria for 1245.110 and 1245.121

  • Age ≥18 years (Japan, age ≥20 years)
  • Chronic heart failure (HF) new york hear association (NYHA) class II to IV

  • Ejection fraction (EF) and N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) criteria

    • 1245.110: preserved EF (Left ventricular ejection fraction (LVEF) >40%) and elevated NT-proBNP (>300 pg/ml; >900 pg/ml for patients with atrial fibrillation)
    • 1245.121: reduced EF (LVEF ≤40%) and elevated NT-proBNP (≥2500 pg/ml if EF 36 to 40%, ≥1000 pg/ml if EF 31 to 35%, ≥600 pg/ml if EF ≤30% or if EF ≤40% with documented hospitalisation for HF within 12 months prior to screening; for patients with atrial fibrillation, double the level of NT-proBNP is applied for each EF category)
  • 1245.110 only: structural heart disease within 6 months or documented hospitalisation for HF within 12 months prior to screening
  • 1245.121 only: stable dose of medical therapy for HF consistent with local and international cardiology guidelines

Exclusion criteria for 1245.25

  • Uncontrolled hyperglycemia: fasting plasma glucose >240 mg/dl
  • Severe renal impairment defined as eGFR \<30 ml/min by Modification of diet in renal disease (MDRD) formula
  • Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial, or participating in another trial (involving an investigational drug and/or follow-up)

Exclusion criteria for 1245.110 and 1245.121

  • Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or transient ischaemic attack ≤90 days before screening
  • Heart transplant recipient, or listed for heart transplant
  • Acute decompensated HF
  • Systolic blood pressure (SBP) ≥180 mmHg at randomisation
  • Symptomatic hypotension and/or SBP \<100 mmHg at screening or randomisation
  • Impaired renal function defined as Estimated glomerular filtration rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration Equation (based on serum creatinine value) \<20 ml/min/1.73 m2 or requiring dialysis at screening
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
16,746 participants (actual)
Patient registry
No

Groups and cohorts

  • EMPA-REG - Placebo

    Participants of the EMP-REG OUTCOME study (1245.25) who received placebo.

    Drug: Placebo

  • EMPA-REG - Empagliflozin low dose

    Participants of the EMPA-REG OUTCOME study (1245.25) who received a low dose of empagliflozin once daily (QD).

    Drug: Empagliflozin

  • EMPA-REG - Empagliflozin high dose

    Participants of the EMP-REG OUTCOME study (1245.25) who received a high dose of empagliflozin once daily (QD).

    Drug: Empagliflozin

  • EMPEROR-Preserved - Empagliflozin

    Participants of the EMPEROR-Preserved study (1245.110) who received empagliflozin once daily (QD).

    Drug: Empagliflozin

  • EMPEROR-Preserved - Placebo

    Participants of the EMPEROR-Preserved study (1245.110) who received placebo once daily (QD).

    Drug: Placebo

  • EMPEROR-Reduced - Empagliflozin

    Participants of the EMPEROR-Reduced study (1245.121) who received empagliflozin once daily (QD).

    Drug: Empagliflozin

  • EMPEROR-Reduced - Placebo

    Participants of the EMPEROR-Reduced study (1245.121) who received placebo once daily (QD).

    Drug: Placebo

Interventions

  • DrugPlacebo

    Placebo

  • DrugEmpagliflozin

    Empagliflozin once daily

06

What researchers measure

Primary outcomes

  1. Incidence Rate of Lower Limb Amputation (LLA)

    Incidence rate of lower limb amputation (LLA). Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. Abbreviation: pt-yrs = patient-years.

    Time frame: From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days.

Secondary outcomes

  1. Incidence Rate of Adverse Events Related to Amputation

    Incidence rate of adverse events (AEs) related to amputation. Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. A search with a pre-defined list of MedDRA preferred terms was performed to identify all AEs related to amputation. These AE included vascular disorders, diabetic-foot-related events, wound/infections, nervous system disorders and volume depletion events. Abbreviation: pt-yrs = patient-years.

    Time frame: From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days.

07

Results

Posted Feb 8, 2024
Limitations and caveats
For study NCT01131676, events leading to LLA were not prespecified but were identified during unblinded medical review of data. Also, since both empagliflozin arms (10 and 25 mg) of study NCT01131676 were combined for the pooled SAF-M1 analysis, this led not only to a different sample size, but also to different patient populations for placebo and empagliflozin, respectively.

Participant flow

This meta-analysis includes three randomised, placebo-controlled, double-blind, parallel-group and event-driven studies (NCT01131676, NCT03057951, NCT03057977) to evaluate the risk of lower-limb amputation (LLA) in patients treated with empagliflozin compared to placebo in the pooled population (SAF-M1 vs. SAF-M2).

Participant flow — Overall Study
MilestoneTrial NCT01131676: PlaceboTrial NCT01131676: Empagliflozin 10 mgTrial NCT01131676: Empagliflozin 25 mgTrial NCT03057951: PlaceboTrial NCT03057951: Empagliflozin 10 mgTrial NCT03057977: PlaceboTrial NCT03057977: Empagliflozin 10 mg
Started2337234723442991299718671863
Treated2333234523422989299618631863
Completed1650179018002046205113521381
Not completed687557544945946515482
Withdrew: Study drug stopped, reason missing5346100
Withdrew: Other than stated below17314312544452831
Withdrew: Patient refusal to continue, not due to ae17211812230428412492
Withdrew: Lost to follow-up15966161117
Withdrew: Protocol violation151512302455
Withdrew: Adverse event303267273553575343337
Withdrew: Not treated4222140

Outcome measures

SecondaryIncidence Rate of Adverse Events Related to Amputation

Incidence rate of adverse events (AEs) related to amputation. Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. A search with a pre-defined list of MedDRA preferred terms was performed to identify all AEs related to amputation. These AE included vascular disorders, diabetic-foot-related events, wound/infections, nervous system disorders and volume depletion events. Abbreviation: pt-yrs = patient-years.

Time frame:
From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days.
Reported as:
Number · Patients with events per 100 pt-yrs
Incidence Rate of Adverse Events Related to Amputation
Patients with events per 100 pt-yrsSAF-M1 PlaceboSAF-M1 EmpagliflozinSAF-M2 PlaceboSAF-M2 Empagliflozin 10 mgTrial NCT01131676: PlaceboTrial NCT01131676: Empagliflozin 10 mg or 25 mgTrial NCT03057951: PlaceboTrial NCT03057951: Empagliflozin 10 mgTrial NCT03057977: PlaceboTrial NCT03057977: Empagliflozin 10 mg
Vascular adverse event1.48 (1.28 to 1.69)1.57 (1.40 to 1.75)1.27 (1.03 to 1.54)1.21 (0.98 to 1.47)1.77 (1.44 to 2.13)1.81 (1.57 to 2.06)1.21 (0.94 to 1.51)1.17 (0.90 to 1.47)1.44 (0.98 to 1.97)1.33 (0.90 to 1.85)
Diabetic foot related AE0.50 (0.39 to 0.63)0.64 (0.53 to 0.76)0.32 (0.21 to 0.46)0.46 (0.32 to 0.62)0.75 (0.54 to 0.99)0.76 (0.62 to 0.93)0.38 (0.23 to 0.55)0.30 (0.18 to 0.46)0.18 (0.05 to 0.39)0.84 (0.51 to 1.26)
Infections potentially related to LLA2.19 (1.94 to 2.44)2.04 (1.85 to 2.25)1.85 (1.56 to 2.17)1.78 (1.50 to 2.09)2.64 (2.23 to 3.09)2.22 (1.96 to 2.50)1.97 (1.62 to 2.36)1.75 (1.42 to 2.11)1.57 (1.09 to 2.13)1.88 (1.35 to 2.49)
Wound/infection0.86 (0.71 to 1.02)0.86 (0.73 to 0.99)0.65 (0.49 to 0.84)0.46 (0.32 to 0.62)1.14 (0.87 to 1.43)1.12 (0.94 to 1.32)0.61 (0.42 to 0.83)0.48 (0.32 to 0.68)0.76 (0.44 to 1.16)0.40 (0.18 to 0.70)
Nervous system disorder1.54 (1.34 to 1.76)1.81 (1.62 to 2.00)0.85 (0.66 to 1.07)0.92 (0.72 to 1.14)2.53 (2.12 to 2.96)2.41 (2.14 to 2.70)0.92 (0.69 to 1.19)0.99 (0.74 to 1.27)0.67 (0.37 to 1.05)0.75 (0.44 to 1.15)
Volume depletion0.67 (0.54 to 0.81)0.65 (0.54 to 0.77)0.95 (0.75 to 1.18)1.16 (0.94 to 1.41)0.28 (0.16 to 0.43)0.32 (0.23 to 0.43)0.90 (0.67 to 1.17)1.16 (0.90 to 1.46)1.08 (0.69 to 1.55)1.16 (0.76 to 1.64)
Statistical analysis
  • SAF-M1 Placebo vs SAF-M1 Empagliflozin · Regression, Cox · p = 0.9946 · Hazard ratio (hr): 1.00 · 95% CI 0.83 to 1.20Comparison versus Placebo \[Treatment/ Placebo\].
  • SAF-M2 Placebo vs SAF-M2 Empagliflozin 10 mg · Regression, Cox · p = 0.7474 · Hazard ratio (hr): 0.95 · 95% CI 0.72 to 1.27Comparison versus placebo. \[Treatment/Placebo\].
  • Trial NCT01131676: Placebo vs Trial NCT01131676: Empagliflozin 10 mg or 25 mg · Regression, Cox · p = 0.7943 · Hazard ratio (hr): 1.03 · 95% CI 0.81 to 1.31Comparison vs. Placebo \[Treatment / Placebo\]
  • Trial NCT03057951: Placebo vs Trial NCT03057951: Empagliflozin 10 mg · Regression, Cox · p = 0.8518 · Hazard ratio (hr): 0.97 · 95% CI 0.69 to 1.36Comparison vs. Placebo \[Treatment / Placebo\].
  • Trial NCT03057977: Placebo vs Trial NCT03057977: Empagliflozin 10 mg · Regression, Cox · p = 0.7660 · Hazard ratio (hr): 0.93 · 95% CI 0.56 to 1.53Comparison vs Placebo \[Treatment/Placebo\]
  • SAF-M1 Placebo vs SAF-M1 Empagliflozin · Regression, Cox · p = 0.3612 · Hazard ratio (hr): 1.15 · 95% CI 0.85 to 1.55Comparison versus placebo \[Treatment/Placebo\].
  • SAF-M2 Placebo vs SAF-M2 Empagliflozin 10 mg · Regression, Cox · p = 0.1610 · Hazard ratio (hr): 1.44 · 95% CI 0.86 to 2.40Comparison versus Placebo \[Treatment/Placebo\].
  • Trial NCT01131676: Placebo vs Trial NCT01131676: Empagliflozin 10 mg or 25 mg · Regression, Cox · p = 0.9128 · Hazard ratio (hr): 1.02 · 95% CI 0.71 to 1.47Comparison vs. Placebo \[Treatment/Placebo\]
  • Trial NCT03057951: Placebo vs Trial NCT03057951: Empagliflozin 10 mg · Regression, Cox · p = 0.5276 · Hazard ratio (hr): 0.81 · 95% CI 0.43 to 1.54Comparison vs. Placebo \[Treatment/Placebo\]
  • Trial NCT03057977: Placebo vs Trial NCT03057977: Empagliflozin 10 mg · Regression, Cox · p = 0.0048 · Hazard ratio (hr): 4.72 · 95% CI 1.60 to 13.87Comparison vs Placebo \[Treatment / Placebo\]
  • SAF-M1 Placebo vs SAF-M1 Empagliflozin · Regression, Cox · p = 0.1526 · Hazard ratio (hr): 0.89 · 95% CI 0.77 to 1.04Comparison versus Placebo \[Treatment/Placebo\].
  • SAF-M2 Placebo vs SAF-M2 Empagliflozin 10 mg · Regression, Cox · p = 0.7430 · Hazard ratio (hr): 0.96 · 95% CI 0.76 to 1.21Comparison versus Placebo \[Treatment/Placebo\].
  • Trial NCT01131676: Placebo vs Trial NCT01131676: Empagliflozin 10 mg or 25 mg · Regression, Cox · p = 0.1049 · Hazard ratio (hr): 0.85 · 95% CI 0.69 to 1.04Comparison vs Placebo \[Treatment/Placebo\]
  • Trial NCT03057951: Placebo vs Trial NCT03057951: Empagliflozin 10 mg · Regression, Cox · p = 0.3950 · Hazard ratio (hr): 0.89 · 95% CI 0.67 to 1.17Comparison vs Placebo \[Treatment/Placebo\]
  • Trial NCT03057977: Placebo vs Trial NCT03057977: Empagliflozin 10 mg · Regression, Cox · p = 0.4429 · Hazard ratio (hr): 1.19 · 95% CI 0.76 to 1.87Comparison vs Placebo \[Treatment/Placebo\]
  • SAF-M1 Placebo vs SAF-M1 Empagliflozin · Regression, Cox · p = 0.3396 · Hazard ratio (hr): 0.89 · 95% CI 0.70 to 1.13Comparison versus Placebo \[Treatment/Placebo\].
  • SAF-M2 Placebo vs SAF-M2 Empagliflozin 10 mg · Regression, Cox · p = 0.1050 · Hazard ratio (hr): 0.70 · 95% CI 0.46 to 1.08Comparison versus Placebo \[Treatment/Placebo\].
  • Trial NCT01131676: Placebo vs Trial NCT01131676: Empagliflozin 10 mg or 25 mg · Regression, Cox · p = 0.9919 · Hazard ratio (hr): 1.00 · 95% CI 0.74 to 1.35Comparison vs Placebo \[Treatment/Placebo\]
  • Trial NCT03057951: Placebo vs Trial NCT03057951: Empagliflozin 10 mg · Regression, Cox · p = 0.3634 · Hazard ratio (hr): 0.79 · 95% CI 0.48 to 1.31Comparison vs Placebo \[Treatment/Placebo\]
  • Trial NCT03057977: Placebo vs Trial NCT03057977: Empagliflozin 10 mg · Regression, Cox · p = 0.1177 · Hazard ratio (hr): 0.52 · 95% CI 0.23 to 1.18Comparison vs Placebo \[Treatment/Placebo\]
  • SAF-M1 Placebo vs SAF-M1 Empagliflozin · Regression, Cox · p = 0.9992 · Hazard ratio (hr): 1.00 · 95% CI 0.84 to 1.19Comparison versus Placebo \[Treatment/Placebo\].
  • SAF-M2 Placebo vs SAF-M2 Empagliflozin 10 mg · Regression, Cox · p = 0.6274 · Hazard ratio (hr): 1.09 · 95% CI 0.78 to 1.52Comparison versus Placebo \[Treatment/Placebo\].
  • Trial NCT01131676: Placebo vs Trial NCT01131676: Empagliflozin 10 mg or 25 mg · Regression, Cox · p = 0.7597 · Hazard ratio (hr): 0.97 · 95% CI 0.79 to 1.19Comparison vs Placebo \[Treatment/Placebo\]
  • Trial NCT03057951: Placebo vs Trial NCT03057951: Empagliflozin 10 mg · Regression, Cox · p = 0.7067 · Hazard ratio (hr): 1.08 · 95% CI 0.74 to 1.57Comparison vs Placebo \[Treatment/Placebo\]
  • Trial NCT03057977: Placebo vs Trial NCT03057977: Empagliflozin 10 mg · Regression, Cox · p = 0.7404 · Hazard ratio (hr): 1.12 · 95% CI 0.56 to 2.25Comparison vs Placebo \[Treatment/Placebo\]
  • SAF-M1 Placebo vs SAF-M1 Empagliflozin · Regression, Cox · p = 0.1765 · Hazard ratio (hr): 1.21 · 95% CI 0.92 to 1.58Comparison versus Placebo \[Treatment/Placebo\].
  • SAF-M2 Placebo vs SAF-M2 Empagliflozin 10 mg · Regression, Cox · p = 0.1978 · Hazard ratio (hr): 1.22 · 95% CI 0.90 to 1.66Comparison versus Placebo \[Treatment/Placebo\].
  • Trial NCT01131676: Placebo vs Trial NCT01131676: Empagliflozin 10 mg or 25 mg · Regression, Cox · p = 0.6561 · Hazard ratio (hr): 1.14 · 95% CI 0.64 to 2.05Comparison vs Placebo \[Treatment/Placebo\]
  • Trial NCT03057951: Placebo vs Trial NCT03057951: Empagliflozin 10 mg · Regression, Cox · p = 0.1699 · Hazard ratio (hr): 1.29 · 95% CI 0.90 to 1.87Comparison vs Placebo \[Treatment/Placebo\]
  • Trial NCT03057977: Placebo vs Trial NCT03057977: Empagliflozin 10 mg · Regression, Cox · p = 0.7944 · Hazard ratio (hr): 1.08 · 95% CI 0.62 to 1.87Comparison vs Placebo \[Treatment/Placebo\]
PrimaryIncidence Rate of Lower Limb Amputation (LLA)

Incidence rate of lower limb amputation (LLA). Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. Abbreviation: pt-yrs = patient-years.

Time frame:
From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days.
Reported as:
Number · Patients with events per 100pt-yrs
Incidence Rate of Lower Limb Amputation (LLA)
Patients with events per 100pt-yrsSAF-M1 PlaceboSAF-M1 EmpagliflozinSAF-M2 PlaceboSAF-M2 Empagliflozin 10 mgTrial NCT01131676: PlaceboTrial NCT01131676: Empagliflozin 10 mg or 25 mgTrial NCT03057951: PlaceboTrial NCT03057951: Empagliflozin 10 mgTrial NCT03057977: PlaceboTrial NCT03057977: Empagliflozin 10 mg
Incidence Rate of Lower Limb Amputation (LLA)0.40 (0.30 to 0.52)0.48 (0.39 to 0.58)0.27 (0.17 to 0.39)0.23 (0.13 to 0.34)0.59 (0.41 to 0.81)0.64 (0.51 to 0.79)0.27 (0.15 to 0.42)0.20 (0.10 to 0.33)0.27 (0.10 to 0.52)0.31 (0.12 to 0.58)
Statistical analysis
  • SAF-M1 Placebo vs SAF-M1 Empagliflozin · Regression, Cox · p = 0.9276 · Hazard ratio (hr): 1.02 · 95% CI 0.73 to 1.42Comparison versus placebo \[Treatment/Placebo\].
  • SAF-M2 Placebo vs SAF-M2 Empagliflozin 10 mg · Regression, Cox · p = 0.6205 · Hazard ratio (hr): 0.85 · 95% CI 0.45 to 1.60Comparison versus placebo \[Treatment/Placebo\]
  • Trial NCT01131676: Placebo vs Trial NCT01131676: Empagliflozin 10 mg or 25 mg · Regression, Cox · p = 0.6768 · Hazard ratio (hr): 1.09 · 95% CI 0.73 to 1.63Comparison vs Placebo \[Treatment/Placebo\]
  • Trial NCT03057951: Placebo vs Trial NCT03057951: Empagliflozin 10 mg · Regression, Cox · p = 0.4294 · Hazard ratio (hr): 0.73 · 95% CI 0.34 to 1.59Comparison versus Placebo \[Treatment /Placebo\]
  • Trial NCT03057977: Placebo vs Trial NCT03057977: Empagliflozin 10 mg · Regression, Cox · p = 0.7826 · Hazard ratio (hr): 1.17 · 95% CI 0.39 to 3.47Comparison versus Placebo \[Treatment /Placebo\]

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SAF-M1 Placebo———
SAF-M1 Empagliflozin 10 mg———
SAF-M1 Empagliflozin 25 mg———
SAF-M2 Placebo———
SAF-M2 Empagliflozin 10 mg———
Trial NCT01131676: Placebo———
Trial NCT01131676: Empagliflozin 10 mg———
Trial NCT01131676: Empagliflozin 25 mg———
Trial NCT03057977: Placebo———
Trial NCT03057977: Empagliflozin 10 mg———
Trial NCT03057951: Placebo———
Trial NCT03057951: Empagliflozin 10 mg———

Baseline characteristics

Treated Set (TS): Patients treated with at least 1 dose of study medication.

Age, Continuous
Age, Continuous(Years)Trial NCT01131676: PlaceboTrial NCT01131676: Empagliflozin 10 mgTrial NCT01131676: Empagliflozin 25 mgTrial NCT03057951: PlaceboTrial NCT03057951: Empagliflozin 10 mgTrial NCT03057977: PlaceboTrial NCT03057977: Empagliflozin 10 mgTotal
Mean63.2 ± 8.863.0 ± 8.663.2 ± 8.671.9 ± 9.671.8 ± 9.366.5 ± 11.267.2 ± 10.867.1 ± 10.2
Sex: Female, Male
Sex: Female, Male(Participants)Trial NCT01131676: PlaceboTrial NCT01131676: Empagliflozin 10 mgTrial NCT01131676: Empagliflozin 25 mgTrial NCT03057951: PlaceboTrial NCT03057951: Empagliflozin 10 mgTrial NCT03057977: PlaceboTrial NCT03057977: Empagliflozin 10 mgTotal
Female653692659133613384534375568
Male168016531683165316581410142611163
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Trial NCT01131676: PlaceboTrial NCT01131676: Empagliflozin 10 mgTrial NCT01131676: Empagliflozin 25 mgTrial NCT03057951: PlaceboTrial NCT03057951: Empagliflozin 10 mgTrial NCT03057977: PlaceboTrial NCT03057977: Empagliflozin 10 mgTotal
Hispanic or Latino4184324157537706136164017
Not Hispanic or Latino191219091926223522261175116412547
Unknown or Not Reported341107583167
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Trial NCT01131676: PlaceboTrial NCT01131676: Empagliflozin 10 mgTrial NCT01131676: Empagliflozin 25 mgTrial NCT03057951: PlaceboTrial NCT03057951: Empagliflozin 10 mgTrial NCT03057977: PlaceboTrial NCT03057977: Empagliflozin 10 mgTotal
American Indian or Alaska Native201123104902415287
Asian5115055014114133343373012
Native Hawaiian or Other Pacific Islander43319146857
Black or African American120119118125133134123872
White167817071696225422851301132512246
More than one race00075603328196
Unknown or Not Reported00111312761
08

Study locations

1 site
  • Boehringer Ingelheim
    Ingelheim am Rhein, 55218, Germany
09

References and documents

Related links

Study documents

  • Study protocol · Apr 10, 2019
  • Statistical analysis plan · Apr 10, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04937816
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jun 24, 2021
Start date
Jun 1, 2021
Primary completion
Jul 13, 2021
Completion
Jul 13, 2021
Results posted
Feb 8, 2024
Last update
Feb 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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