Metabolic Effects of Metformin Therapy in Obstructive Sleep Apnea

NCT04530747 on ClinicalTrials.gov Phase 1/2 Pennington Biomedical Research Center (academic or other) Started 2021-01-28 Terminated

Riskier than 44% of active trials

Model scores of the 29,894 trials active now.

Model score 16% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (121 trials).

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

How it ended

Terminated on 2021-11-30, after 2021-01-28 start.

Reason given by the sponsor: “other”

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 2021-11-30. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: metforminobstructivebreasttissuepressure
Phrases that lowered it: participantfoodindexmonthsvisit
Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 35 (lowers risk) · Who can join
Phase: 1/2 (raises risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Sponsor's past termination rate: 6.2% (lowers risk) · Sponsor's track record
Blinding: quadruple (lowers risk) · Design
Drug's FAERS reports with a death: 8.1% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Primary purpose: prevention (lowers risk) · Design
Drug's FAERS reports marked serious: 66.6% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports before start: 323030 (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Responsible party: principal investigator (lowers risk) · Design
Disease area, respiratory: Yes (raises risk) · Disease area
Sponsor's past trials: 113 (lowers risk) · Sponsor's track record
Number of arms: 2 (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 36673 (raises 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: 1/2 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 35 (typical: 18)
Maximum age: 65 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 113 (typical: 32)
Sponsor's past termination rate: 6.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 14 (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: 323030 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 36673 (typical: 412.5)
Drug's FAERS reports marked serious: 66.6% (typical: 85.6%)
Drug's FAERS reports with a death: 8.1% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology, respiratory
Drugs matched to FDA substances: metformin

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

Study of Cardiovascular Disease and Obstructive Sleep Apnea NCT01637623 · started 2012 · scored riskier than 46% of active trials completed
A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea NCT03796026 · started 2019 · scored riskier than 12% of active trials completed
A Study to Assess the Efficacy and Safety of Lorundrostat in Participants With Obstructive Sleep Apnea and Hypertension NCT06785454 · started 2025 · scored riskier than 9% of active trials completed
Acetazolamide for Obstructive Sleep Apnea to Improve Heart Health NCT05616260 · started 2022 · scored riskier than 23% of active trials completed
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea NCT05412004 · started 2022 · 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.