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A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes

NCT03407599 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-06-19

No results posted yet for this study

Summary

The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children \[6-11 years\], adolescents \[12-17 years\] and adults \[18-64 years\]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapid®.

Conditions

Interventions

DRUG

Faster aspart

An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.

DRUG

Insulin aspart (NovoRapid®)

An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2018-07-05
Completion
2018-07-05
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

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 NCT03407599 on ClinicalTrials.gov