MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

NCT00722371 on ClinicalTrials.gov Phase 3 Merck Sharp & Dohme LLC (industry) Started 2008-09-05 Completed

Riskier than 12% of active trials

Model scores of the 29,894 trials active now.

Model score 8% 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 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 2011-03-25, after 2008-09-05 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 2011-03-25. 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: disease includingpatient haspatient iscirrhosisinhibitor
Phrases that lowered it: type diabeteswith typeand safetymetforminefficacy and
Sponsor's past termination rate: 15.2% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 44.2% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 4.4% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports before start: 38856 (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Maximum age: 78 (raises risk) · Who can join
Responsible party: sponsor (lowers risk) · Design
Number of arms: 7 (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: 3 (typical: 2)
Number of arms: 7 (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: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 78 (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: 434 (typical: 32)
Sponsor's past termination rate: 15.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 280 (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: 38856 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 12428 (typical: 412.5)
Drug's FAERS reports marked serious: 44.2% (typical: 85.6%)
Drug's FAERS reports with a death: 4.4% (typical: 15.9%)

Disease area and drugs

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

Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128) NCT00885352 · started 2009 · scored riskier than 17% of active trials completed
A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074) NCT00813995 · started 2008 · scored riskier than 7% of active trials completed
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254) NCT01590797 · started 2012 · scored riskier than 24% of active trials completed
Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260) NCT01462266 · started 2012 · scored riskier than 55% of active trials completed
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253) NCT01590771 · started 2012 · scored riskier than 27% 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.