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Trial ยท NCT05465317

Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease

NCT05465317, Completed, Boehringer Ingelheim; results first posted 2024-09-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease. Trials, record NCT05465317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05465317

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease
NCT number
NCT05465317
Status
Completed
Enrollment
62,197 participants, actual
Lead sponsor
Boehringer Ingelheim
Conditions
Diabetes Mellitus, Type 2
Interventions
Empagliflozin, Dipeptidyl Peptidate-4 inhibitors
First posted
2022-07-19
Last updated
2024-09-19
Results first posted
2024-09-19
Limitations and caveats
Limitations inherent to all electronic health record (EHR) based studies, including potential for missing data (i.e., data that was generated through a different health system) or inaccurate data based on billing codes. This limitation could have resulted in HCRU not captured in the current study which could have attenuated the observed results (e.g., medications, hospitalizations, etc).

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause Death
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
40% decline in eGFR: at least 2 measurements during follow-up of at least a 40% decline relative to baseline separated by \>= 28 days. the second eGFR measurement is required to be within 2 years from index, at which time, all patients were censored. ESKD: at least 1 kidney transplant or ESKD diagnosis/procedure or at least 2 dialysis diagnoses/procedures separated by \>= 28 days or eGFR\<15 on 2 measurements separated by \>= 28 days. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and for the CKD and non-CKD cohorts.
SecondaryIncidence Rate of the 40% Decline in Estimated Glomerular Filtration Rate (eGFR)
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
40% decline in eGFR: at least 2 measurements (second measurement must be within 2 years) during follow-up of at least a 40% decline relative to baseline separated by \>= 28 days. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts.
SecondaryIncidence Rate of End-stage Kidney Disease (ESKD)
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
ESKD definition: at least 1 kidney transplant or ESKD diagnosis/procedure or at least 2 dialysis diagnoses/procedures separated by \>= 28 days or eGFR\<15 on 2 measurements separated by \>= 28 days. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts.
SecondaryIncidence Rate of Dialysis
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Incident dialysis, given dialysis in the 12 months preceding index date is a disqualifying diagnosis/procedure. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts.
SecondaryIncidence Rate of Kidney Transplant
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Kidney transplant: any procedure associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts.
SecondaryIncidence Rate of Composite Outcome Including Acute Hospitalization for Heart Failure and All-cause Death
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Composite outcome including acute hospitalization for heart failure and All-cause death: Any diagnosis of heart failure associated with hospital admission, including inpatient and emergency department (ED) to inpatient encounters. From death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts.
SecondaryIncidence Rate of Acute Hospitalization for Heart Failure
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Acute hospitalization for heart failure: Any diagnosis of heart failure associated with hospital admission, including inpatient and emergency department (ED) to inpatient encounters. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. A LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts.
SecondaryIncidence Rate of All-cause Death
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
All-cause death, from death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO (least absolute shrinkage and selection operator) overlap weighting was used. a LASSO penalized regression model was created with the covariates of interest, subgroup variables, and all pairwise covariate-subgroup interactions. Outcome for this model was treatment group (DPP4i as the reference). The variables chosen by the LASSO model were refit to a logistic model in order to calculate the propensity score (PS) estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts.
SecondaryIncidence Rate of the Composite Outcome Including MI, Stroke, All-cause Death and Coronary Revascularization Procedure
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Composite outcome including MI, Stroke, All-cause death and Coronary revascularization procedure: For MI and stroke, any inpatient diagnosis associated with healthcare encounters, including inpatient and ED to inpatient For all-cause death, death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts.
SecondaryIncidence Rate of the Composite Outcome Including MI, Stroke, All-cause Death (MACE)
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Composite outcome including MI, Stroke, All-cause death: For MI and stroke, any inpatient diagnosis associated with healthcare encounters, including inpatient and ED to inpatient For all-cause death, death records provided by sites, supplemented with linkage using Datavant Software. Post-LASSO overlap weighting was used. A LASSO penalized regression model was created with covariates of interest, subgroup variables, and all pairwise interactions. Variables chosen by the LASSO model were refit to a logistic model in order to calculate the PS estimates. The overlap weights were then created such that the weights were equal to the PS for participants prescribed the reference treatment (DPP4i) and 1-PS for participants prescribed empagliflozin. Results are presented for the overall cohort and separately for the CKD and non-CKD cohorts.

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIncidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause Death
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
(First) events per 1000 patient yearsNUMBER
SECONDARYIncidence Rate of the 40% Decline in Estimated Glomerular Filtration Rate (eGFR)
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
(First) events per 1000 patient yearsNUMBER
SECONDARYIncidence Rate of End-stage Kidney Disease (ESKD)
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
(First) events per 1000 patient yearsNUMBER
SECONDARYIncidence Rate of Dialysis
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
(First) events per 1000 patient yearsNUMBER
SECONDARYIncidence Rate of Kidney Transplant
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
(First) events per 1000 patient yearsNUMBER
SECONDARYIncidence Rate of Composite Outcome Including Acute Hospitalization for Heart Failure and All-cause Death
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
(First) events per 1000 patient yearsNUMBER
SECONDARYIncidence Rate of Acute Hospitalization for Heart Failure
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
(First) events per 1000 patient yearsNUMBER
SECONDARYIncidence Rate of All-cause Death
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
(First) events per 1000 patient yearsNUMBER
SECONDARYIncidence Rate of the Composite Outcome Including MI, Stroke, All-cause Death and Coronary Revascularization Procedure
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
(First) events per 1000 patient yearsNUMBER
SECONDARYIncidence Rate of the Composite Outcome Including MI, Stroke, All-cause Death (MACE)
Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years.
Primary study cohort: Patient with type 2 diabetes who initiated Empagliflozin or Dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020. Based on existing data from 20 United States (US) health systems that have mapped their electronic health record (EHR) data to the National Patient-Centered Clinical Research Network (PCORnet) Common Data Model.
(First) events per 1000 patient yearsNUMBER

Results by group96

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause DeathEmpagliflozin Initiators - Propensity Scored-weighted26.65(First) events per 1000 patient years
Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause DeathDipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators - Propensity Scored-weighted36.65(First) events per 1000 patient years
Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause DeathEmpagliflozin Initiators - Chronic Kidney Disease (CKD) Cohort44.15(First) events per 1000 patient years
Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause DeathDPP4i Initiators - Chronic Kidney Disease (CKD) Cohort67.36(First) events per 1000 patient years
Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause DeathEmpagliflozin Initiators - Non-Chronic Kidney Disease (Non-CKD) Cohort22.62(First) events per 1000 patient years
Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause DeathDPP4i Initiators - Non-Chronic Kidney Disease (Non-CKD) Cohort29.33(First) events per 1000 patient years
Incidence Rate of the 40% Decline in Estimated Glomerular Filtration Rate (eGFR)Empagliflozin Initiators - Propensity Scored-weighted12.10(First) events per 1000 patient years
Incidence Rate of the 40% Decline in Estimated Glomerular Filtration Rate (eGFR)Dipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators - Propensity Scored-weighted16.55(First) events per 1000 patient years
Incidence Rate of the 40% Decline in Estimated Glomerular Filtration Rate (eGFR)Empagliflozin Initiators - Chronic Kidney Disease (CKD) Cohort16.46(First) events per 1000 patient years
Incidence Rate of the 40% Decline in Estimated Glomerular Filtration Rate (eGFR)DPP4i Initiators - Chronic Kidney Disease (CKD) Cohort27.39(First) events per 1000 patient years

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDEmpagliflozin Initiators20,279
Overall StudySTARTEDDipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators41,918
Overall StudyCOMPLETEDEmpagliflozin Initiators20,279
Overall StudyCOMPLETEDDipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators41,918
Overall StudyNOT COMPLETEDEmpagliflozin Initiators0
Overall StudyNOT COMPLETEDDipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators0

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityEmpagliflozin Initiators34120,279
Total, all-cause mortalityDipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators1,52841,918
Total, other adverse eventsEmpagliflozin Initiators00
Total, other adverse eventsDipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators00
Total, serious adverse eventsEmpagliflozin Initiators00
Total, serious adverse eventsDipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators00

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
39142723DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Empagliflozin Initiators vs Dipeptidyl Peptidate-4 Inhibitor (DPP4i) Initiators: deaths from any cause

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05465317

GET https://conductscience.org/api/trials/v1/NCT05465317/results?page=2