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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: Faster aspart; Drug: Insulin aspart (NovoRapid®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03407599

2017-002014-31 (Registry Identifier)

NN1218-4371

U1111-1197-0428 (Other Identifier)

Details and patient eligibility

About

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®.

Enrollment: 46 patients

Sex: All

Ages: 6 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

Faster aspart followed by insulin aspart (NovoRapid®)

Experimental group

Description:

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.

Treatment:

Drug: Insulin aspart (NovoRapid®)

Drug: Faster aspart

Insulin aspart (NovoRapid®) followed by faster aspart

Experimental group

Description:

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.

Treatment:

Drug: Insulin aspart (NovoRapid®)

Drug: Faster aspart