A Study to Investigate the Glucose Lowering Effects of Dextromethorphan Alone or in Combination With Sitagliptin in Subjects With Type 2 Diabetes Mellitus (T2DM) After an Oral Glucose Tolerance Test

NCT01936025 on ClinicalTrials.gov Phase 2 Profil Institut für Stoffwechselforschung GmbH (industry) Started 2013-10-31 Completed

Riskier than 19% of active trials

Model scores of the 29,894 trials active now.

Model score 11% 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 2014-04-30, after 2013-10-31 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 2014-04-30. 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

Design: crossover (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Minimum age: 45 (lowers risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Blinding: double (raises risk) · Design
Number of arms: 8 (lowers risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: placebostabledoublecontrolledsubjects with
Phrases that lowered it: both inclusivemetformincross overagedway
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports before start: 67690 (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports in the prior 12 months: 9360 (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Maximum age: 70 (raises risk) · Who can join

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: 8 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 45 (typical: 18)
Maximum age: 70 (typical: 71)
Sex: male (typical: all)
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 9 (typical: 32)
Sponsor's past termination rate: 11.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 4 (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: 67690 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 9360 (typical: 412.5)
Drug's FAERS reports marked serious: 78.8% (typical: 85.6%)
Drug's FAERS reports with a death: 18.5% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, endocrine
Drugs matched to FDA substances: dextromethorphan, 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

Drug Interaction Study Between Dorzagliatin and Sitagliptin NCT03790839 · started 2019 · scored riskier than 7% of active trials completed
Drug Interaction Study Between Dorzagliatin and Empagliflozin NCT03790787 · started 2019 · scored riskier than 7% of active trials completed
Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin NCT00947557 · started 2009 · scored riskier than 9% of active trials terminated
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
Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control NCT02273050 · started 2014 · scored riskier than 9% 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.