Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil
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 6% of the time (816 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-04-23, after 2019-10-28 start.
Reason given by the sponsor: “other”
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 2021-04-23. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: patientmultipleneuropathypancreaticascending
Phrases that lowered it: both inclusiveopen labelinsulinevaluatetrial -
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Collaborators: 2 (lowers risk) · Design
-
Blinding: none (lowers risk) · Design
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Design: sequential (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 4 (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 4 (lowers risk) · Sponsor's track record
-
Disease area, neurology: No (lowers risk) · Disease area
-
Responsible party: sponsor (lowers 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
- 1 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 64 (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
- 4 (typical: 32)
- Sponsor's past termination rate
- 25% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, immunology, endocrine
- Drugs matched to FDA substances
- none matched
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
- Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus NCT02702011 · started 2016 · scored riskier than 10% of active trials completed
- Effect of Dosing Time and Meal on IN-105 (Insulin Tregopil) PK and PD NCT03392961 · started 2014 · scored riskier than 18% of active trials completed
- The Potential of Dapagliflozin Plus Exenatide in Obese Insulin-resistant Patients NCT03419624 · started 2018 · scored riskier than 17% of active trials terminated
- 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
- Gan & Lee Insulin Glargine Target Type (1) Evaluating Research NCT03371082 · started 2017 · scored riskier than 17% 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.