A Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Patients With Type 2 Diabetes Mellitus

NCT01381887 on ClinicalTrials.gov Phase 1 Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (industry) Started 2011-06-30 Completed

Riskier than 8% of active trials

Model scores of the 29,894 trials active now.

Model score 7% 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 2011-11-30, after 2011-06-30 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 2011-11-30. 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

Design: crossover (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: placebocellpurposetransplantationmg dl
Phrases that lowered it: effect ofthe effectcrossoverwith typeperiod
Sponsor's past termination rate: 9.4% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Minimum age: 25 (lowers risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 67 (lowers risk) · Sponsor's track record
Maximum age: 70 (raises risk) · Who can join
Number of arms: 4 (lowers risk) · Design
Blinding: quadruple (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises 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: crossover (typical: parallel)
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 25 (typical: 18)
Maximum age: 70 (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: 406 (typical: 32)
Sponsor's past termination rate: 9.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 67 (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: 1 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (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

Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) NCT02009488 · started 2014 · scored riskier than 21% 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 Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus NCT01128985 · started 2010 · scored riskier than 45% of active trials completed
An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy NCT01340664 · started 2011 · scored riskier than 12% of active trials completed
A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM) NCT02139943 · started 2014 · scored riskier than 22% 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.