PINIT Study: Primary Intranasal Insulin Trial
Model scores of the 29,894 trials active now.
Model score 7% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (220 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-06-07, after 2018-05-25 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 2021-06-07. 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
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Collaborators: 4 (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
-
Sponsor's past termination rate: 5.6% (lowers risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
-
Blinding: triple (raises risk) · Design
-
Design: parallel (raises risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: type diabeteshlacellsnegativemoderate to
Phrases that lowered it: childrenaimpreventionnasaland safety -
Minimum age: 1 (lowers risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
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Keywords listed: 10 (raises risk) · Design
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Sponsor's past trials: 71 (lowers risk) · Sponsor's track record
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 4 (typical: 0)
- Keywords listed
- 10 (typical: 1)
Who can join
- Minimum age
- 1 (typical: 18)
- Maximum age
- 7 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 71 (typical: 32)
- Sponsor's past termination rate
- 5.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, immunology, endocrine
- Drugs matched to FDA substances
- none matched
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
- Pre-POINT-Early Study NCT02547519 · started 2015 · scored riskier than 10% of active trials completed
- Fr1da Insulin Intervention NCT02620072 · started 2015 · scored riskier than 10% of active trials completed
- GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial) NCT03364868 · started 2018 · scored riskier than 7% of active trials completed
- Insulin and Abatacept in Recently-diagnosed Type 1 Diabetes NCT05742243 · started 2023 · scored riskier than 32% of active trials completed
- Safety Study to Assess Whether Proinsulin Peptide Injections Can Slow or Stop the Body Damaging Its Own Insulin-making Cells in the Pancreas in Patients Newly Diagnosed With Type 1 Diabetes NCT01536431 · started 2012 · scored riskier than 44% 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.