A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections

NCT05462756 on ClinicalTrials.gov Phase 3 Eli Lilly and Company (industry) Started 2022-08-11 Completed

Riskier than 9% 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 9% of the time (803 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2024-02-27, after 2022-08-11 start.

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 2024-02-27. 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: basalheartpriorto screeninginjections
Phrases that lowered it: type diabetesinsulinwith typemetformindaily
Accepts healthy volunteers: No (raises risk) · Who can join
Drug's FAERS reports marked serious: 56.5% (lowers risk) · Drug's FDA history
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 6.7% (lowers risk) · Drug's FDA history
Sponsor's past trials: 1498 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 144 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Maximum age: not given (lowers risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area

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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (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: 1498 (typical: 32)
Sponsor's past termination rate: 7.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 144 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 353653 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 24060 (typical: 412.5)
Drug's FAERS reports marked serious: 56.5% (typical: 85.6%)
Drug's FAERS reports with a death: 6.7% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, endocrine
Drugs matched to FDA substances: insulin glargine, insulin lispro

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 Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time NCT05362058 · started 2022 · scored riskier than 7% of active trials completed
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin NCT05275400 · started 2022 · scored riskier than 8% of active trials completed
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1) NCT05662332 · started 2023 · scored riskier than 14% of active trials completed
Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy NCT02855684 · started 2016 · scored riskier than 9% of active trials completed
A Study for Patients With Type 2 Diabetes NCT01027871 · started 2010 · scored riskier than 13% 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.