A Clinical Trial to Study the Efficacy, Safety, Tolerability and Pharmacokinetics of P2202 in Patients of Type 2 Diabetes

NCT01674348 on ClinicalTrials.gov Phase 2 Piramal Enterprises Limited (industry) Started 2011-04-30 Terminated

Riskier than 58% of active trials

Model scores of the 29,894 trials active now.

Model score 18% 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

Terminated on 2013-07-31, after 2011-04-30 start.

Reason given by the sponsor: “enrollment”

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 2013-07-31. 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

Sponsor's past termination rate: 50% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: acutemg dlplacebophase iicontrolled
Phrases that lowered it: kgsubjects whopharmacokineticsscreeningmale
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Blinding: double (raises risk) · Design
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 5 (lowers risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Number of arms: 2 (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Collaborators: 0 (raises risk) · Design
Maximum age: 65 (raises risk) · Who can join
Primary purpose: treatment (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: 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: 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: 2 (typical: 32)
Sponsor's past termination rate: 50% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 5 (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, endocrine
Drugs matched to FDA substances: none matched

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

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Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes NCT03230786 · started 2017 · scored riskier than 17% of active trials completed
A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM) NCT01386099 · started 2011 · scored riskier than 13% of active trials completed
A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug On Adults With Type 2 Diabetes Mellitus Taking Metformin NCT02053103 · started 2014 · scored riskier than 58% of active trials terminated
PF-06291874 Multiple Ascending Dose Study In Type 2 Diabetes Mellitus Patients NCT01856595 · started 2013 · scored riskier than 87% 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.