Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes

NCT02518945 on ClinicalTrials.gov Phase 3 University at Buffalo (academic or other) Started 2015-08-31 Completed

Riskier than 38% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (159 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2016-04-30, after 2015-08-31 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 2016-04-30. 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) (raises risk) · Wording Phrases that raised it: 30weightwomensinglerandomized
Phrases that lowered it: patients withcancercarcinomain patientscriteria patients
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 10.5% (raises risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 8.3% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Blinding: quadruple (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Drug's FAERS reports marked serious: 68.7% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports before start: 160480 (lowers risk) · Drug's FDA history
Has a data monitoring committee: Yes (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 38300 (lowers risk) · Drug's FDA history
Responsible party: principal investigator (lowers risk) · Design
Number of arms: 2 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 3 (raises 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: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 80 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 19 (typical: 32)
Sponsor's past termination rate: 10.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 3 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 7 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 160480 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 38300 (typical: 412.5)
Drug's FAERS reports marked serious: 68.7% (typical: 85.6%)
Drug's FAERS reports with a death: 8.3% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, immunology, endocrine
Drugs matched to FDA substances: dapagliflozin, insulin aspart, insulin detemir, insulin glargine, insulin glulisine, insulin lispro, liraglutide

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

Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes NCT02460978 · started 2015 · scored riskier than 21% of active trials completed
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes NCT02268214 · started 2014 · scored riskier than 22% of active trials completed
BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes NCT01498185 · started 2012 · scored riskier than 22% of active trials completed
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo NCT02229396 · started 2014 · scored riskier than 9% of active trials completed
LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors. NCT02964247 · started 2017 · 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.