Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)

NCT01948986 on ClinicalTrials.gov Phase 1 Merck Sharp & Dohme LLC (industry) Started 2013-10-01 Completed

Riskier than 14% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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 6% of the time (816 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 2014-10-16, after 2013-10-01 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 2014-10-16. 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: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 16.8% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Sponsor's past trials: 988 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 140 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Number of arms: 5 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Maximum age: 80 (raises risk) · Who can join
Collaborators: 1 (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: 1 (typical: 2)
Number of arms: 5 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 80 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 988 (typical: 32)
Sponsor's past termination rate: 16.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 140 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

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

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 the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001) NCT01986855 · started 2013 · scored riskier than 45% of active trials completed
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment NCT02836873 · started 2016 · scored riskier than 26% of active trials completed
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes NCT02413398 · started 2015 · scored riskier than 41% of active trials completed
A Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Participants With Type 2 Diabetes and Inadequate Glycemic Control on Metformin Monotherapy (MK-8835-012) NCT02630706 · started 2015 · scored riskier than 22% of active trials completed
Assessing the Effect of Met DR on Plasma Glucose and PK in Subjects With T2DM NCT01804842 · started 2012 · scored riskier than 5% 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.