Gestational Diabetes: Insulin or Oral Hypoglycemic Agents?
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (159 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 2016-05-31, after 2010-08-31 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 2016-05-31. 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) (raises risk) · Wording
Phrases that raised it: diabetestypemellitusenglishimprove
Phrases that lowered it: weeks28takescombinationwomen -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 57.0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 6.9% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises 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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Minimum age: 18 (raises risk) · Who can join
-
Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports before start: 48685 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 9820 (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (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
- 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
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (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
- academic or other
- Sponsor's past trials
- 9 (typical: 32)
- Sponsor's past termination rate
- 11.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 10 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 48685 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9820 (typical: 412.5)
- Drug's FAERS reports marked serious
- 57.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, urogenital, endocrine
- Drugs matched to FDA substances
- glyburide, 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
- Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus NCT03651531 · started 2018 · scored riskier than 29% of active trials terminated
- Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus NCT03320694 · started 2016 · scored riskier than 5% of active trials completed
- Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin NCT03841591 · started 2018 · scored riskier than 6% of active trials completed
- Efficacy of Metformin in Achieving Glycaemia Goals as Recommended for the Treatment of Gestational Diabetes in Non Obese Women NCT01756105 · started 2012 · scored riskier than 55% 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.