Efficacy and Safety of TAK-875 in Combination With Sitagliptin in Participants With Type 2 Diabetes Mellitus
Model scores of the 29,894 trials active now.
Model score 32% 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
Completed on 2012-08-31, after 2011-08-31 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 2012-08-31. 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) (raises risk) · Wording
Phrases that raised it: has historyparticipantmetformincellmg
Phrases that lowered it: hepatitisvirusand safetymaleefficacy and -
Sponsor's past termination rate: 12.4% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports marked serious: 40.3% (lowers risk) · Drug's FDA history
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 6 (lowers risk) · Design
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Drug's FAERS reports with a death: 3.2% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 41 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Keywords listed: 1 (raises risk) · Design
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Maximum age: 80 (raises risk) · Who can join
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Collaborators: 0 (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
- 2
- Number of arms
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 80 (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
- 194 (typical: 32)
- Sponsor's past termination rate
- 12.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 41 (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
- 12372 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2469 (typical: 412.5)
- Drug's FAERS reports marked serious
- 40.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.2% (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
- Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes NCT01456195 · started 2011 · scored riskier than 99% of active trials completed
- Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes NCT01481116 · started 2012 · scored riskier than 92% of active trials terminated
- Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes NCT01834274 · started 2013 · scored riskier than 40% of active trials terminated
- TAK-875 (Fasiglifam) in Combination With Sitagliptin in Adults With Type 2 Diabetes NCT01829464 · started 2013 · scored riskier than 72% of active trials terminated
- Comparison of TAK-875 to Placebo as an Add-on to Glimepiride in Patients With Type 2 Diabetes NCT01829477 · started 2013 · scored riskier than 52% of active trials terminated
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.