A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus

NCT01128985 on ClinicalTrials.gov Phase 1 Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (industry) Started 2010-03-31 Completed

Riskier than 45% of active trials

Model scores of the 29,894 trials active now.

Model score 16% 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 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 2010-07-31, after 2010-03-31 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 2010-07-31. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: diabetictype diabetesplacebopatients mustdiabetes mellitus
Phrases that lowered it: pharmacokineticmgoral administrationthe pharmacokineticsdose
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Minimum age: 25 (lowers risk) · Who can join
Sponsor's past termination rate: 9.3% (raises risk) · Sponsor's track record
Blinding: triple (raises risk) · Design
Design: parallel (raises risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 66 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past trials: 355 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Number of arms: 4 (lowers risk) · Design
Maximum age: 65 (raises risk) · Who can join
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: randomized
Design: parallel
Primary purpose: treatment
Blinding: triple (typical: none)
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 5 (typical: 1)

Who can join

Minimum age: 25 (typical: 18)
Maximum age: 65 (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: 355 (typical: 32)
Sponsor's past termination rate: 9.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 66 (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, endocrine
Drugs matched to FDA substances: canagliflozin

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

A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus NCT01177163 · started 2008 · scored riskier than 51% of active trials completed
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride NCT00968812 · started 2009 · scored riskier than 14% of active trials completed
A Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Patients With Type 2 Diabetes Mellitus NCT01381887 · started 2011 · scored riskier than 8% of active trials completed
An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes NCT00642278 · started 2008 · scored riskier than 18% of active trials completed
A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers NCT01281579 · started 2011 · scored riskier than 2% 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.