Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes
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 2020-12-17, after 2017-11-22 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 2020-12-17. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: of screeningwomen withscansubjectacute
Phrases that lowered it: the effectinsulin degludecparticipantseffect ofinsulin aspart -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: 5.6% (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 6.4% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 72 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 62.6% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 621 (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 13273 (lowers risk) · Drug's FDA history
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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
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 621 (typical: 32)
- Sponsor's past termination rate
- 5.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 72 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 51072 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13273 (typical: 412.5)
- Drug's FAERS reports marked serious
- 62.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, immunology, endocrine
- Drugs matched to FDA substances
- insulin aspart, insulin degludec, insulin detemir
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
- Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes NCT03770767 · started 2019 · scored riskier than 16% of active trials completed
- Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD) NCT02932475 · started 2017 · scored riskier than 15% of active trials terminated
- Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes NCT01662921 · started 2013 · scored riskier than 18% of active trials completed
- Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus NCT03651531 · started 2018 · scored riskier than 29% of active trials terminated
- Metformin in Women With Type 2 Diabetes in Pregnancy Trial NCT01353391 · started 2011 · scored riskier than 15% 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.