A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

NCT01682759 on ClinicalTrials.gov Phase 3 Merck Sharp & Dohme LLC (industry) Started 2012-09-10 Completed

Riskier than 57% of active trials

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (803 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 2015-01-26, after 2012-09-10 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 2015-01-26. 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: coronarythe safetysubjectssafety anddisorder
Phrases that lowered it: participantsmkcancertrialweeks
Sponsor's past termination rate: 16.6% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Sponsor's past trials: 901 (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 9.0% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Trials the sponsor started in the prior 2 years: 153 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 69.7% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports in the prior 12 months: 24969 (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports before start: 122487 (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Blinding: double (raises risk) · Design
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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 18
Maximum age: not given (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: 901 (typical: 32)
Sponsor's past termination rate: 16.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 153 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 122487 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 24969 (typical: 412.5)
Drug's FAERS reports marked serious: 69.7% (typical: 85.6%)
Drug's FAERS reports with a death: 9.0% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, endocrine
Drugs matched to FDA substances: glimepiride, insulin glargine, metformin, omarigliptin

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 to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027) NCT01863667 · started 2013 · scored riskier than 30% of active trials terminated
Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022) NCT01704261 · started 2012 · scored riskier than 33% of active trials completed
A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006) NCT01217073 · started 2010 · scored riskier than 72% of active trials completed
A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024) NCT01755156 · started 2013 · scored riskier than 27% of active trials completed
A Study of the Safety and Efficacy of Omarigliptin (MK-3102) in ≥18 and <45 Year-Old Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028) NCT01814748 · started 2013 · scored riskier than 36% 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.