A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
Model scores of the 29,894 trials active now.
Model score 14% 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 11% of the time (493 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 2011-08-31, after 2010-07-31 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 2011-08-31. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: metforminplacebostabletype diabetesthe purpose
Phrases that lowered it: evaluate theefficacyto evaluatesafetysubjects -
Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Responsible party: not given (raises risk) · Design
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 2.3% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 29.6% (lowers risk) · Drug's FDA history
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Number of arms: 6 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 0 (lowers 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
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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
- 9717 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2294 (typical: 412.5)
- Drug's FAERS reports marked serious
- 29.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, endocrine
- Drugs matched to FDA substances
- sitagliptin
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
- Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of SHR3824 in Type 2 Diabetes Mellitus Patients NCT02346175 · started 2014 · scored riskier than 28% of active trials completed
- Randomized Sitagliptin Withdrawal Study (MK-0431-845) NCT02738879 · started 2016 · scored riskier than 14% of active trials completed
- Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes NCT00661362 · started 2008 · scored riskier than 5% of active trials completed
- Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects NCT06688123 · started 2025 · scored riskier than 12% of active trials completed
- Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control NCT02273050 · started 2014 · scored riskier than 9% 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.