A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001)

NCT02269735 on ClinicalTrials.gov Phase 1 Merck Sharp & Dohme LLC (industry) Started 2014-11-26 Completed

Riskier than 12% of active trials

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 0% 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 2016-07-29, after 2014-11-26 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 2016-07-29. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 17.6% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: tolerabilityand pharmacodynamicspharmacodynamics ofhas historythe safety
Phrases that lowered it: healthyevaluatepharmacokinetichepatitisparticipants
Phase: 1 (lowers risk) · Design
Sponsor's past trials: 1053 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 7.4% (lowers risk) · Drug's FDA history
Drug's FAERS reports marked serious: 71.6% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 130 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: No (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Maximum age: 55 (lowers risk) · Who can join
Disease area, psychiatry: No (lowers risk) · Disease area
Keywords listed: 0 (raises risk) · Design
Number of arms: 11 (lowers risk) · Design
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: 11 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 55 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 1053 (typical: 32)
Sponsor's past termination rate: 17.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 130 (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: 14318 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3004 (typical: 412.5)
Drug's FAERS reports marked serious: 71.6% (typical: 85.6%)
Drug's FAERS reports with a death: 7.4% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, immunology, endocrine
Drugs matched to FDA substances: insulin aspart

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

Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001) NCT03170544 · started 2017 · scored riskier than 7% of active trials completed
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1293 Compared With a Basal Insulin in Participants With Type 1 Diabetes (MK-1293-005) NCT02059174 · started 2014 · scored riskier than 10% of active trials completed
Study of the Safety and Efficacy of MK-8521 Compared to Placebo and a Diabetes Drug in Participants With Type 2 Diabetes Mellitus (MK-8521-003) NCT01982630 · started 2013 · scored riskier than 13% of active trials completed
A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED) NCT00758680 · started 2008 · scored riskier than 51% of active trials terminated
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002) NCT01640873 · started 2012 · scored riskier than 24% 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.