Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus (T2DM) Patients
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (816 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-01-31, after 2015-03-31 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 2016-01-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: ascendingtolerabilitypatientdosesmetformin
Phrases that lowered it: healthyand safetymmhgkgbody -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 58 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 8.2% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports marked serious: 63.9% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 111579 (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 792 (raises risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 4 (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 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- basic science (typical: treatment)
- Blinding
- double (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
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 792 (typical: 32)
- Sponsor's past termination rate
- 11.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 58 (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
- 111579 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 23637 (typical: 412.5)
- Drug's FAERS reports marked serious
- 63.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.2% (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
- A Study to Test How SB756050 Affects Subjects With Type 2 Diabetes Mellitus After 6 Days of Dosing. NCT00733577 · started 2008 · scored riskier than 8% of active trials completed
- Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus NCT02229227 · started 2014 · scored riskier than 24% of active trials completed
- The Potential of Dapagliflozin Plus Exenatide in Obese Insulin-resistant Patients NCT03419624 · started 2018 · scored riskier than 17% of active trials terminated
- A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus NCT02954601 · started 2016 · scored riskier than 6% of active trials completed
- A Study in Type 2 Diabetics of Single and Multiple Doses of Orally Administered GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics NCT01119846 · started 2009 · scored riskier than 8% 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.