A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

NCT02119819 on ClinicalTrials.gov Phase 2 OPKO Health, Inc. (industry) Started 2014-04-30 Completed

Riskier than 7% of active trials

Model scores of the 29,894 trials active now.

Model score 6% 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 2015-10-31, after 2014-04-30 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 2015-10-31. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: stablepriordlplacebomonths
Phrases that lowered it: participantsmetformincomparebmidrugs
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 6.2% (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Drug's FAERS reports marked serious: 50.7% (lowers risk) · Drug's FDA history
Maximum age: 80 (raises risk) · Who can join
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 6.1% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Number of arms: 6 (lowers risk) · Design
Blinding: double (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area

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: 6 (typical: 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: 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: industry (typical: academic or other)
Sponsor's past trials: 16 (typical: 32)
Sponsor's past termination rate: 6.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 7 (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: 133826 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 17930 (typical: 412.5)
Drug's FAERS reports marked serious: 50.7% (typical: 85.6%)
Drug's FAERS reports with a death: 6.1% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, endocrine
Drugs matched to FDA substances: exenatide, 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 of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone NCT05971940 · started 2023 · scored riskier than 17% of active trials completed
Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) NCT00577824 · started 2008 · scored riskier than 5% of active trials completed
A Study in Adults With Type 2 Diabetes NCT01421459 · started 2011 · scored riskier than 9% of active trials completed
A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2) NCT00637273 · started 2008 · scored riskier than 6% of active trials completed
A Study of LY3437943 in Participants With Type 2 Diabetes NCT04867785 · started 2021 · scored riskier than 18% 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.