A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (816 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2011-02-14, after 2008-07-18 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2011-02-14. 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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Sponsor's past termination rate: 15.1% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: or equalequal tomultiplecreatinineestimated
Phrases that lowered it: pharmacokineticssafetystudy todrugssingle -
Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports marked serious: 18.0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 1.0% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 273 (raises risk) · Sponsor's track record
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Number of arms: 4 (lowers risk) · Design
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Blinding: double (raises risk) · Design
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Maximum age: 17 (raises risk) · Who can join
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Minimum age: 10 (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
- 4 (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
- 0 (typical: 1)
Who can join
- Minimum age
- 10 (typical: 18)
- Maximum age
- 17 (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
- 416 (typical: 32)
- Sponsor's past termination rate
- 15.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 273 (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
- 4428 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2732 (typical: 412.5)
- Drug's FAERS reports marked serious
- 18.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, endocrine
- Drugs matched to FDA substances
- sitagliptin
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
- Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics of Sitagliptin NCT00960453 · started 2008 · scored riskier than 0% of active trials completed
- A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Sitagliptin When Given Together to Healthy Subjects NCT01104532 · started 2010 · scored riskier than 1% of active trials completed
- Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083) NCT01485614 · started 2012 · scored riskier than 15% of active trials completed
- Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects NCT00935467 · started 2009 · scored riskier than 3% of active trials completed
- Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Tablets in Healthy Male and Female Volunteers NCT05549583 · started 2018 · 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.