Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus
Model scores of the 29,894 trials active now.
Model score 5% 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 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 2017-03-27, after 2015-05-14 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 2017-03-27. 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: cellcancerpatientpriorsquamous
Phrases that lowered it: labelopenvisitand safetyjapanese -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 20 (lowers risk) · Who can join
-
Sponsor's past termination rate: 5.5% (lowers risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 41.0% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports with a death: 4.8% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 132 (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 6 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 327 (lowers risk) · Sponsor's track record
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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
- 3 (typical: 2)
- Number of arms
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (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
- 327 (typical: 32)
- Sponsor's past termination rate
- 5.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 132 (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
- 3608 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1718 (typical: 412.5)
- Drug's FAERS reports marked serious
- 41.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, endocrine
- Drugs matched to FDA substances
- empagliflozin, empagliflozin linagliptin, linagliptin
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
- Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients NCT01708902 · started 2012 · scored riskier than 6% of active trials completed
- Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM NCT03429543 · started 2018 · scored riskier than 15% of active trials completed
- Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug naïve or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control NCT01214239 · started 2010 · scored riskier than 6% of active trials completed
- Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy NCT01215097 · started 2010 · scored riskier than 6% of active trials completed
- Linagliptin Add-on to Insulin Background Therapy NCT02897349 · started 2016 · scored riskier than 6% 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.