An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients

Model scores of the 29,894 trials active now.

Model score 11% 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2016-01-31. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 8.2% (lowers risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 64.4% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Number of arms: 4 (lowers risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Maximum age: not given (lowers risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 19475 (raises risk) · Drug's FDA history
• Disease area, neurology: No (lowers risk) · Disease area
• Drug's FAERS reports before start: 100518 (raises risk) · Drug's FDA history
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: in subjectssubjects withtherapystablestudy is
  Phrases that lowered it: participanteffecttype diabeteswith typehealth

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.

• Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients NCT02151461 · started 2014 · scored riskier than 11% 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
• A Study of the Safety and Efficacy of Sitagliptin Addition During Metformin Up-titration (MK-0431-848) NCT02791490 · started 2016 · scored riskier than 17% of active trials completed
• Randomized Sitagliptin Withdrawal Study (MK-0431-845) NCT02738879 · started 2016 · scored riskier than 14% of active trials completed
• Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM NCT02526524 · started 2015 · scored riskier than 11% 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.