Safety and Efficacy of Once-Daily KRP-104 in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone
Model scores of the 29,894 trials active now.
Model score 10% 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 2011-01-31, after 2009-10-31 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 2011-01-31. 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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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: 2 (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 5 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: or equalequal togreaterstablecontrol
Phrases that lowered it: blood pressurekgonce dailymmhgto visit -
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Has a data monitoring committee: No (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
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Maximum age: 75 (lowers risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises 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
- 2
- Number of arms
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, endocrine
- Drugs matched to FDA substances
- none matched
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
- Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM NCT02526524 · started 2015 · scored riskier than 11% of active trials completed
- A Study to Assess the Efficacy and Safety of Ipragliflozin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin NCT02794792 · started 2016 · scored riskier than 10% of active trials completed
- Safety and Efficacy of BGP-15 in Patients With Type 2 Diabetes Mellitus NCT01069965 · started 2010 · scored riskier than 11% of active trials terminated
- A Study in Participants With Type 2 Diabetes Mellitus NCT01468987 · started 2011 · scored riskier than 12% of active trials completed
- A Study to Compare the Effect of a Double Dose of Two Long-acting Insulin Therapies in Participants With Type 2 Diabetes NCT02132637 · started 2014 · scored riskier than 6% 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.