Efficacy of Mifepristone in Males With Type 2 Diabetes Mellitus
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (220 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-05-31, after 2017-02-03 start.
Reason given by the sponsor: “business”
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 2021-05-31. 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
-
Sponsor's past termination rate: 18.8% (raises risk) · Sponsor's track record
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: concurrentmg dltherapyagentscancer
Phrases that lowered it: type diabetesinsulinwith typedailyuse of -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 41.1% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 4.8% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Blinding: double (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor's past trials: 16 (lowers risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 1 (lowers risk) · Sponsor's track record
-
Collaborators: 0 (raises risk) · Design
-
Drug's FAERS reports before start: 2357 (raises risk) · Drug's FDA history
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 16 (typical: 32)
- Sponsor's past termination rate
- 18.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 2357 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 378 (typical: 412.5)
- Drug's FAERS reports marked serious
- 41.1% (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
- mifepristone
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
- Mifepristone Effects on Glucose Intolerance in Obese/Overweight Adults NCT01419535 · started 2011 · scored riskier than 6% of active trials completed
- Assessing the Effect of Met DR on Plasma Glucose and PK in Subjects With T2DM NCT01804842 · started 2012 · scored riskier than 5% of active trials completed
- Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM) NCT01889667 · started 2013 · scored riskier than 22% 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
- Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005) NCT02099110 · started 2014 · scored riskier than 44% 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.