A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (220 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 2019-08-31, after 2013-09-30 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 2019-08-31. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 10.1% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 23.1% (lowers risk) · Drug's FDA history
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: carcinomatransplantationcellrenalfailure
Phrases that lowered it: diabeteswith typesafety ofwomentrial to -
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 114 (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: triple (raises risk) · Design
-
Drug's FAERS reports with a death: 1.4% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports before start: 42430 (lowers risk) · Drug's FDA history
-
Number of arms: 2 (raises risk) · Design
-
Sponsor's past trials: 268 (lowers risk) · Sponsor's track record
-
Collaborators: 0 (raises 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 268 (typical: 32)
- Sponsor's past termination rate
- 10.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 114 (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
- 42430 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 912 (typical: 412.5)
- Drug's FAERS reports marked serious
- 23.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, immunology, endocrine
- Drugs matched to FDA substances
- exenatide
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
- Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes NCT01855490 · started 2012 · scored riskier than 39% of active trials completed
- Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases NCT03017352 · started 2016 · scored riskier than 13% of active trials completed
- Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus NCT00765817 · started 2008 · scored riskier than 6% of active trials completed
- Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL) NCT02194595 · started 2014 · scored riskier than 26% of active trials completed
- Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4) NCT00676338 · started 2008 · scored riskier than 16% 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.