Prebiotics and Metformin Improve Gut and Hormones in Type 2 Diabetes in Youth (MIGHTY-fiber)
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 18% of the time (785 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-07-15, after 2020-03-10 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 2021-07-15. 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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Design: crossover (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: placebochroniceffectssubjectages
Phrases that lowered it: participantsmetforminparticipantbloodtype diabetes -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 5.2% (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 8.0% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 8 (raises risk) · Sponsor's track record
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Sponsor's past trials: 287 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 65.9% (lowers risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Minimum age: 10 (raises risk) · Who can join
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Collaborators: 0 (raises risk) · Design
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Sponsor type: government (raises risk) · Sponsor's track record
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 10 (typical: 18)
- Maximum age
- 25 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 287 (typical: 32)
- Sponsor's past termination rate
- 5.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 293395 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 39563 (typical: 412.5)
- Drug's FAERS reports marked serious
- 65.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, endocrine
- 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
- Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function NCT04114357 · started 2020 · scored riskier than 19% of active trials completed
- Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes NCT02960659 · started 2017 · scored riskier than 20% of active trials completed
- Metformin Therapy for Overweight Adolescents With Type 1 Diabetes NCT01881828 · started 2013 · scored riskier than 33% of active trials completed
- GPR119 Agonist for Hypoglycemia in Type 1 Diabetes NCT04432090 · started 2021 · scored riskier than 6% of active trials completed
- Lactobacillus Johnsonii Supplementation in Adults With T1D NCT03961347 · started 2020 · scored riskier than 53% 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.