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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2018-07-05

Brief Summary

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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®.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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Faster aspart followed by insulin aspart (NovoRapid®)

Participants will receive single dose of fast-acting insulin aspart followed by single dose of NovoRapid® on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.

Group Type EXPERIMENTAL

Faster aspart

Intervention Type DRUG

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®)

Intervention Type DRUG

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

Insulin aspart (NovoRapid®) followed by faster aspart

Participants will receive single dose of NovoRapid® followed by single dose of fast-acting insulin aspart on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.

Group Type EXPERIMENTAL

Faster aspart

Intervention Type DRUG

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®)

Intervention Type DRUG

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

Interventions

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Faster aspart

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No