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Diluted Insulin in Young Children: Bigger Volumes for Smaller Patients

NCT03666065 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-08-14

No results posted yet for this 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

  • Type1diabetes

Interventions

DRUG

Aspart insulin

Standard insulin

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Jennifer Sherr, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
9 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03666065 on ClinicalTrials.gov