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NCT02603510 · ClinicalTrials.gov registry record · Phase 1

Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion

A Phase 1 study, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT02603510: Completed Phase 1 study, sponsored by Sanofi.

NCT02603510 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02603510, a Phase 1 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study Summary

Primary Objective: * Assess the safety of SAR342434 and Humalog when used in external pumps. Secondary Objectives: * Intervals for infusion set changes. * Incidence of insulin pump alarms for infusion set occlusion. * Patient observation of infusion set occlusion. * Adverse events including bruising at the infusion site and injection site reactions.

Interventions

  • DRUG insulin lispro
  • DRUG SAR342434

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2015-11
Est. Completion 2016-04
Phase Phase 1
Sanofi

713 total trials

What the finished NCT02603510 record still lists

NCT02603510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 2 interventions - of which insulin lispro is the first listed.

NCT02603510 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02603510 about?

NCT02603510 is a clinical study titled "Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion". Primary Objective: * Assess the safety of SAR342434 and Humalog when used in external pumps. Secondary Objectives: * Intervals for infusion set changes. * Incidence of insulin pump alarms for infusion set occlusion. * Patient observation of infusion set occlusion. * Adverse events including bruis...

What is the current status of trial NCT02603510?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2015-11. Estimated completion is 2016-04.

What interventions are being tested in trial NCT02603510?

The interventions under investigation include: insulin lispro (DRUG), SAR342434 (DRUG).

Who is sponsoring clinical trial NCT02603510?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02603510's enrollment target sits among peer trials

27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02603510, the US trial registry maintained by the National Library of Medicine. NCT02603510 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.