A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)

NCT00631488 on ClinicalTrials.gov Phase 2 Merck Sharp & Dohme LLC (industry) Started 2008-02-29 Completed

Riskier than 11% 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 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 2009-01-31, after 2008-02-29 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 2009-01-31. 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: therapyreceptorcontrolledlowdouble blind
Phrases that lowered it: type diabetesmetforminand safetysafety ofparticipants who
Sponsor's past termination rate: 15.2% (raises risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Drug's FAERS reports marked serious: 42.6% (lowers risk) · Drug's FDA history
Minimum age: 21 (lowers risk) · Who can join
Has a data monitoring committee: not given (lowers risk) · Design
Drug's FAERS reports with a death: 4.6% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 258 (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: double (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 12011 (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 23704 (lowers risk) · Drug's FDA history

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: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 21 (typical: 18)
Maximum age: 65 (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: 363 (typical: 32)
Sponsor's past termination rate: 15.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 258 (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: 23704 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 12011 (typical: 412.5)
Drug's FAERS reports marked serious: 42.6% (typical: 85.6%)
Drug's FAERS reports with a death: 4.6% (typical: 15.9%)

Disease area and drugs

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

MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066) NCT00532935 · started 2008 · scored riskier than 6% of active trials completed
A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED) NCT00541450 · started 2008 · scored riskier than 5% of active trials completed
Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED) NCT00767000 · started 2008 · scored riskier than 12% of active trials terminated
A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017) NCT00792935 · started 2009 · scored riskier than 23% of active trials completed
A Study to Assess the Safety and Efficacy of MK8245 in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK8245-005 AM2) NCT00846391 · started 2008 · scored riskier than 16% of active trials terminated

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.