The Effect of Morning Versus Evening Administration on The Pharmacokinetics and Pharmacodynamics of Empagliflozin

NCT03895229 on ClinicalTrials.gov Phase 1 Ain Shams University (academic or other) Started 2018-10-01 Completed

Riskier than 2% of active trials

Model scores of the 29,894 trials active now.

Model score 3% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (137 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2018-10-26, after 2018-10-01 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-10-26. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: to determinediseaseweekscirrhosisand pharmacodynamics
Phrases that lowered it: healthydiabeteseffect ofthe effectdiseases
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 0.6% (lowers risk) · Sponsor's track record
Primary purpose: other (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Drug's FAERS reports marked serious: 51.9% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 180 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 2.4% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Responsible party: principal investigator (lowers risk) · Design
Sponsor's past trials: 158 (lowers risk) · Sponsor's track record
Blinding: none (lowers risk) · Design
Maximum age: 45 (lowers risk) · Who can join

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: other (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 45 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 158 (typical: 32)
Sponsor's past termination rate: 0.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 180 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 9044 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3843 (typical: 412.5)
Drug's FAERS reports marked serious: 51.9% (typical: 85.6%)
Drug's FAERS reports with a death: 2.4% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, endocrine
Drugs matched to FDA substances: empagliflozin

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Bioequivalence Study of Empagliflozin And Linagliptin Tablets in Healthy Chinese Subjects NCT05956522 · started 2022 · scored riskier than 0% of active trials completed
A Study in Healthy People to Test How Empagliflozin is Taken up in the Body When Taken as a Whole Tablet or Dissolved in Water and Mixed With Food NCT06962826 · started 2025 · scored riskier than 3% of active trials completed
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg NCT07266766 · started 2025 · scored riskier than 1% of active trials completed
Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCL 25mg/5mg/1000mg Extended-Release Tablets Versus Trijardy® XR Extended Release Film Coated Tablets NCT07213895 · started 2025 · scored riskier than 0% of active trials completed
Bioequivalence Study of Empagliflozin & Metformin HCL From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany) NCT05132023 · started 2019 · scored riskier than 0% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.