A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes

NCT01796366 on ClinicalTrials.gov Phase 1 Novo Nordisk A/S (industry) Started 2013-02-21 Completed

Riskier than 5% 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 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 2013-08-19, after 2013-02-21 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 2013-08-19. 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: tolerabilityin subjectssubjectsubjects withthe safety
Phrases that lowered it: trialpharmacokineticsproductstype diabeteswith type
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 6.1% (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 83 (lowers risk) · Sponsor's track record
Blinding: double (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports with a death: 11.0% (lowers risk) · Drug's FDA history
Sponsor's past trials: 458 (raises risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports before start: 53333 (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 8522 (lowers risk) · Drug's FDA history
Drug's FAERS reports marked serious: 78.6% (lowers risk) · Drug's FDA history
Number of arms: 2 (raises risk) · Design
Maximum age: 64 (raises risk) · Who can join

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: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (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: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 458 (typical: 32)
Sponsor's past termination rate: 6.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 83 (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: 53333 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8522 (typical: 412.5)
Drug's FAERS reports marked serious: 78.6% (typical: 85.6%)
Drug's FAERS reports with a death: 11.0% (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 Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes NCT02964104 · started 2016 · scored riskier than 5% of active trials completed
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes NCT02148861 · started 2014 · scored riskier than 7% of active trials completed
A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes NCT01028404 · started 2009 · scored riskier than 4% of active trials completed
Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy NCT02470039 · started 2015 · scored riskier than 7% of active trials completed
A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus NCT02938572 · started 2016 · 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.