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NCT03666065 · ClinicalTrials.gov registry record · Early Phase 1

Diluted Insulin in Young Children: Bigger Volumes for Smaller Patients

A Early Phase 1 study of Type1diabetes, sponsored by Yale University.

Completed
Registry status
Early Phase 1
Development phase
3
Enrollment target
1
Study location

NCT03666065 is a Early Phase 1 study of Type1diabetes that has completed, run by Yale University. The registered enrollment target is 3 participants, below the 262-participant average among 19 other Type1diabetes trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03666065, a Early Phase 1 study of Type1diabetes, has completed, sponsored by Yale University.

COMPLETED
Registry status
Early Phase 1
Development phase
3 participants
Enrollment target
1
Study location

Study Summary

The aim of this study is to compare the pharmacokinetic (PK) profile of diluted insulin aspart (U25) with undiluted insulin aspart (U100) in school-aged children and adolescents with type 1 diabetes (T1D) utilizing the euglycemic clamp technique and a standardized meal in a controlled research environment. The investigators hypothesize that dilution of insulin aspart (U25) will alter the PK properties as compared to undiluted aspart.

Conditions Studied

Type1diabetes

Interventions

  • DRUG Aspart insulin

Study Locations (1)

Connecticut

  • Yale University School of Medicine - New Haven

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2020-01-01
Est. Completion 2023-06-30
Phase Early Phase 1

Sponsor

Yale University

1,492 total trials

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What the Registry Record Tells You About NCT03666065

The ClinicalTrials.gov registry entry for NCT03666065 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 262-participant average among 19 other Type1diabetes trials with a reported enrollment target (99% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type1diabetes appearing as the primary indexed condition, and to 1 intervention - of which Aspart insulin is the first listed.

NCT03666065 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT03666065 about?

NCT03666065 is a clinical study titled "Diluted Insulin in Young Children: Bigger Volumes for Smaller Patients". The aim of this study is to compare the pharmacokinetic (PK) profile of diluted insulin aspart (U25) with undiluted insulin aspart (U100) in school-aged children and adolescents with type 1 diabetes (T1D) utilizing the euglycemic clamp technique and a standardized meal in a controlled research envir...

What is the current status of trial NCT03666065?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2020-01-01. Estimated completion is 2023-06-30.

What conditions does trial NCT03666065 study?

This clinical trial studies the following conditions: Type1diabetes.

What interventions are being tested in trial NCT03666065?

The interventions under investigation include: Aspart insulin (DRUG).

Who is sponsoring clinical trial NCT03666065?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03666065 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.