NCT03666065

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2020

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

3.5 years

First QC Date

September 7, 2018

Last Update Submit

August 9, 2023

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

  • maximum insulin concentration

    maximum insulin concentration

    240 minutes

Secondary Outcomes (4)

  • Time to peak insulin concentration

    240 minutes

  • Mean Glucose Infusion Rate (GIR)

    240 minutes

  • GIR Max

    240 minutes

  • Time to GIR Max

    240 minutes

Study Arms (2)

Aspart-U100 Insulin

ACTIVE COMPARATOR

Standard Concentration Rapid Acting Insulin

Drug: Aspart insulin

Aspart-U25 Insulin

EXPERIMENTAL

Diluted Concentration of Rapid Acting Insulin

Drug: Aspart insulin

Interventions

Aspart insulinDRUG

Standard insulin

Also known as: Standard Concentration insulin
Aspart-U100 InsulinAspart-U25 Insulin

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • T1D of at least 6 months' duration
  • Aged 9-15 years
  • Continuous subcutaneous insulin therapy for at least 1 month;
  • HbA1c ≤ 10%
  • Normal hematocrit
  • Able to give consent

You may not qualify if:

  • Admission for DKA during the past 4 weeks
  • Severe hypoglycemia during the past 4 weeks
  • Other conditions/medications affecting insulin sensitivity (e.g. metformin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Interventions

Insulin Aspart

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jennifer Sherr, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 11, 2018

Study Start

January 1, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)