A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes

NCT04262661 on ClinicalTrials.gov Phase 1 Novo Nordisk A/S (industry) Started 2020-03-02 Completed

Riskier than 6% of active trials

Model scores of the 29,894 trials active now.

Model score 5% 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

Completed on 2020-09-25, after 2020-03-02 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 2020-09-25. 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
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: effectivetypetolerability pharmacokineticssafety tolerabilitynew
Phrases that lowered it: participantshealthyeffectboth inclusiveblood
Phase: 1 (lowers risk) · Design
Drug's FAERS reports with a death: 8.2% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 73 (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 63.6% (lowers risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Drug's FAERS reports before start: 195475 (lowers risk) · Drug's FDA history
Sponsor's past trials: 704 (raises risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Number of arms: 4 (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports in the prior 12 months: 23122 (lowers risk) · Drug's FDA history

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: quadruple (typical: 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: 64 (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: 704 (typical: 32)
Sponsor's past termination rate: 5.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 73 (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: 195475 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 23122 (typical: 412.5)
Drug's FAERS reports marked serious: 63.6% (typical: 85.6%)
Drug's FAERS reports with a death: 8.2% (typical: 15.9%)

Disease area and drugs

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

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 to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes NCT04569994 · started 2020 · scored riskier than 6% of active trials completed
A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes NCT04136067 · started 2019 · scored riskier than 7% of active trials completed
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes NCT06326047 · started 2024 · scored riskier than 9% of active trials completed
A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes NCT03965013 · started 2019 · scored riskier than 6% of active trials completed
A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes NCT06542874 · started 2024 · scored riskier than 9% 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.