Combination GRA and SGLT-2i Treatment in Type 1 Diabetes
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (56 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-10-31, after 2021-02-22 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 2022-10-31. 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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Design: crossover (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cancerplacebochronictransplantsurgery
Phrases that lowered it: visitasthmakgscreeningweeks -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Collaborators: 3 (lowers risk) · Design
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Sponsor's past termination rate: 10.3% (raises risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 5.6% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: triple (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 65 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 95.1% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Sponsor's past trials: 351 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Primary purpose: basic science (raises risk) · Design
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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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 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
- 351 (typical: 32)
- Sponsor's past termination rate
- 10.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 65 (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
- 7667 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1307 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, immunology, endocrine
- Drugs matched to FDA substances
- dapagliflozin, volagidemab
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
- Dapagliflozin Effects on Hypoglycemia NCT03704818 · started 2018 · scored riskier than 15% of active trials completed
- Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes NCT03444584 · started 2018 · scored riskier than 20% of active trials completed
- Empa Add on to Insulin in Japanese Patient With Type 1 Diabetes Mellitus NCT02702011 · started 2016 · scored riskier than 10% of active trials completed
- Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old NCT03199053 · started 2017 · scored riskier than 25% of active trials completed
- Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes NCT01204775 · started 2011 · scored riskier than 25% 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.