Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

NCT01059825 on ClinicalTrials.gov Phase 2 Merck Sharp & Dohme LLC (industry) Started 2010-02-24 Completed

Riskier than 35% of active trials

Model scores of the 29,894 trials active now.

Model score 14% 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 2011-01-20, after 2010-02-24 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 2011-01-20. 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

Sponsor's past termination rate: 16.0% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: pftypekidney diseasediabetesheart
Phrases that lowered it: participantsefficacymkbodyonce daily
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Drug's FAERS reports marked serious: 48.4% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 5.5% (lowers risk) · Drug's FDA history
Sponsor's past trials: 637 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Blinding: double (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 248 (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 10593 (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Number of arms: 6 (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: 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: 1 (typical: 0)
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 70 (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: 637 (typical: 32)
Sponsor's past termination rate: 16.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 248 (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: 43763 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 10593 (typical: 412.5)
Drug's FAERS reports marked serious: 48.4% (typical: 85.6%)
Drug's FAERS reports with a death: 5.5% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, endocrine
Drugs matched to FDA substances: ertugliflozin, metformin, sitagliptin

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 Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042) NCT01096667 · started 2010 · scored riskier than 42% of active trials completed
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus NCT01336738 · started 2011 · scored riskier than 58% of active trials completed
Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes NCT01338870 · started 2011 · scored riskier than 47% of active trials completed
Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040) NCT01054300 · started 2010 · scored riskier than 9% of active trials completed
Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin NCT01517373 · started 2012 · scored riskier than 45% 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.