A Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Model scores of the 29,894 trials active now.
Model score 5% 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 10% of the time (1,463 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-03-10, after 2021-05-28 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 2023-03-10. 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: failureheartuncontrolledivmyocardial
Phrases that lowered it: visitand safetydiseasesefficacy andto evaluate -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 8.3% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Minimum age: 19 (lowers risk) · Who can join
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Has a data monitoring committee: No (lowers 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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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: not given (lowers risk) · Who can join
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Drug's FAERS reports marked serious: 67.9% (lowers risk) · Drug's FDA history
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Number of arms: 3 (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 383750 (lowers 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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 19 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 61 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (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
- 383750 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 37307 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- dapagliflozin, metformin, pioglitazone
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
- The Potential of Dapagliflozin Plus Exenatide in Obese Insulin-resistant Patients NCT03419624 · started 2018 · scored riskier than 17% of active trials terminated
- A Study to Evaluate the Efficacy and Safety of Gemigliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Dapagliflozin and Metformin (SOLUTION Study) NCT03842267 · started 2019 · scored riskier than 4% 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 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
- 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
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.