A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus

NCT02897219 on ClinicalTrials.gov Phase 3 Astellas Pharma Inc (industry) Started 2016-08-29 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 9% of the time (803 trials).

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

How it ended

Completed on 2018-03-15, after 2016-08-29 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 2018-03-15. 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: subject hasthe subjectdiseasetransplantstage
Phrases that lowered it: insulintype diabeteskgwith typem2
Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 20 (lowers risk) · Who can join
Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Design: parallel (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 23 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Blinding: double (raises risk) · Design
Maximum age: not given (lowers risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 413 (lowers risk) · Sponsor's track record
Drug's FAERS reports before start: 11 (lowers risk) · Drug's FDA history

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: 3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 413 (typical: 32)
Sponsor's past termination rate: 5.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 23 (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: 11 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, immunology, endocrine
Drugs matched to FDA substances: ipragliflozin

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

A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus NCT01071850 · started 2010 · scored riskier than 30% of active trials completed
A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin NCT02452632 · started 2015 · scored riskier than 18% of active trials completed
Pharmacodynamics, Pharmacokinetics, and Safety of ASP1941 in Patients With Type 1 Diabetes Mellitus NCT02529449 · started 2015 · scored riskier than 17% of active trials completed
A Study to Evaluate Long-term Safety and Efficacy of ASP1941 in Diabetes Patients NCT01672762 · started 2012 · scored riskier than 7% of active trials completed
A Study to Evaluate the Effect of ASP1941 in Combination With Metformin in Adult Patients With Type 2 Diabetes Mellitus NCT01117584 · started 2010 · scored riskier than 14% 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.