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

Novo Nordisk A/S46 enrolled

Overview

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

Faster aspartDRUG

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

Insulin aspart (NovoRapid®)DRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female aged 6-64 years (both inclusive) at the time of signing informed consent * Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening * Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm Exclusion Criteria: * Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening * Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) * Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Locations (1)

Novo Nordisk Investigational Site

Hanover, Germany