Pilot Study to Explore the Efficacy of DAPAglifozin as add-on to Closed-loop Control in Patients With Type 1 Diabetes

NCT02987738 on ClinicalTrials.gov Phase 1 Kinderkrankenhaus auf der Bult (academic or other) Started 2017-02-09 Completed

Riskier than 8% of active trials

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 trials).

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

How it ended

Completed on 2017-12-19, after 2017-02-09 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 2017-12-19. 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

Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: subjecthourstherapycelldisease
Phrases that lowered it: screeninginvestigatorthe effectvisitjudged
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 5.9% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Blinding: triple (raises risk) · Design
Drug's FAERS reports marked serious: 94.0% (raises risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Maximum age: 21 (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
Collaborators: 2 (lowers risk) · Design
Number of arms: 2 (raises risk) · Design

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: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: triple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 2 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 12 (typical: 18)
Maximum age: 21 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 3 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 3 (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: 2717 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1073 (typical: 412.5)
Drug's FAERS reports marked serious: 94.0% (typical: 85.6%)
Drug's FAERS reports with a death: 5.9% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: dapagliflozin

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

Phase 1 Study to Explore the Safety and Pharmacokinetics of DAPAglifozin in Adolescents and Adults With Type 1 Diabetes NCT02325206 · started 2014 · scored riskier than 10% of active trials completed
A Comparison of Postprandial Glucose After a MMTT, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study in Subjects With Type 1 Diabetes NCT04956263 · started 2021 · scored riskier than 6% of active trials completed
A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus NCT02954601 · started 2016 · scored riskier than 6% of active trials completed
Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus NCT06498284 · started 2024 · scored riskier than 12% of active trials completed
Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old NCT03199053 · started 2017 · scored riskier than 25% 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.