Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in Combination With Metformin in Type 2 DM (ZEUS II Study)
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 9% of the time (803 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-02-08, after 2016-10-17 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 2018-02-08. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: dlcancerpatientspriorcell
Phrases that lowered it: metforminpatients whoand safetyefficacy andwith type -
Sponsor's past termination rate: 1.9% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Minimum age: 19 (lowers risk) · Who can join
-
Drug's FAERS reports with a death: 7.9% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports marked serious: 62.7% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports before start: 166920 (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 11 (raises risk) · Sponsor's track record
-
Disease area, neurology: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: double (raises risk) · Design
-
Sponsor's past trials: 52 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- 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
- 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
- 52 (typical: 32)
- Sponsor's past termination rate
- 1.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 166920 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 34577 (typical: 412.5)
- Drug's FAERS reports marked serious
- 62.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, endocrine
- Drugs matched to FDA substances
- gemigliptin, 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 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
- The Potential of Dapagliflozin Plus Exenatide in Obese Insulin-resistant Patients NCT03419624 · started 2018 · scored riskier than 17% of active trials terminated
- Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus NCT02496000 · started 2015 · scored riskier than 13% of active trials completed
- Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM) NCT01889667 · started 2013 · scored riskier than 22% of active trials completed
- Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s) NCT03798054 · started 2019 · scored riskier than 7% 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.