A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus
Model scores of the 29,894 trials active now.
Model score 9% 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 11% of the time (493 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
Terminated on 2015-09-30, after 2014-04-30 start.
Reason given by the sponsor: “safety”
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 2015-09-30. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: ulnmultiplestablediagnosisbone
Phrases that lowered it: type diabeteswith typemellitusmetforminkg -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Maximum age: 79 (raises risk) · Who can join
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 850 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: triple (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 168 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 8.0% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports before start: 114529 (raises risk) · Drug's FDA history
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Keywords listed: 0 (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- triple (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
- 18
- Maximum age
- 79 (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
- 850 (typical: 32)
- Sponsor's past termination rate
- 5.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 168 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 114529 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 21944 (typical: 412.5)
- Drug's FAERS reports marked serious
- 61.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, endocrine
- Drugs matched to FDA substances
- metformin, 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
- A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus NCT01558271 · started 2012 · scored riskier than 4% of active trials completed
- A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus NCT01584232 · started 2012 · scored riskier than 6% of active trials completed
- A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus NCT04450394 · started 2020 · scored riskier than 15% of active trials completed
- A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus NCT05407961 · started 2022 · scored riskier than 9% of active trials completed
- A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin NCT00734474 · started 2008 · scored riskier than 8% 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.