Skip to main content
OpenTrials
Completed

NCT Number: NCT03407599

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

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®.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Hanover, 30173, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faster Aspart

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®)

Drug

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

Primary outcomes

  1. AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours

    Time frame: 0-12 hours

    Calculated based on insulin aspart measured in blood.

Secondary outcomes

  1. AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes

    Time frame: 0-15 minutes

    Calculated based on insulin aspart measured in blood.

  2. AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes

    Time frame: 0-30 minutes

    Calculated based on insulin aspart measured in blood.

  3. AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour

    Time frame: 0-1 hour

    Calculated based on insulin aspart measured in blood.

  4. AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour

    Time frame: 0-1½ hour

    Calculated based on insulin aspart measured in blood.

  5. AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours

    Time frame: 0-2 hours

    Calculated based on insulin aspart measured in blood.

  6. Cmax,IAsp, maximum observed serum insulin aspart concentration

    Time frame: 0-12 hours

    Calculated based on insulin aspart measured in blood.

  7. tmax,IAsp, time to maximum observed serum insulin aspart concentration

    Time frame: 0-12 hours

    Calculated based on insulin aspart measured in blood.

  8. Onset of appearanceIAsp, time from trial product administration until the first time serum insulinaspart concentration greater than or equal to Lower Limit Of Quantitation (LLOQ)

    Time frame: 0-12 hours

    Calculated based on insulin aspart measured in blood.

  9. Duration of exposureIAsp, time from trial product administration until the first time serum insulin aspart concentration is equal to LLOQ in the terminal part of the curve

    Time frame: 0-12 hours

    Calculated based on insulin aspart measured in blood.

  10. Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp

    Time frame: 0-12 hours

    Calculated based on insulin aspart measured in blood.

  11. Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp

    Time frame: 0-12 hours

    Calculated based on insulin aspart measured in blood.

  12. Mean change in plasma glucose concentration from 0-1 hour after administration

    Time frame: 0-1 hour

    Calculated based on glucose concentration measured in plasma.

  13. Mean change in plasma glucose concentration from 0-2 hours after administration

    Time frame: 0-2 hours

    Calculated based on glucose concentration measured in plasma.

  14. Mean change in plasma glucose concentration from 0-6 hours after administration

    Time frame: 0-6 hours

    Calculated based on glucose concentration measured in plasma.

  15. Change from baseline in plasma glucose concentration 1 hour after administration

    Time frame: Pre-dose (0 hour), 1 hour

    Calculated based on glucose concentration measured in plasma.

  16. Change from baseline in plasma glucose concentration 2 hours after administration

    Time frame: Pre-dose (0 hour), 2 hours

    Calculated based on glucose concentration measured in plasma.

  17. Plasma glucose concentration 1 hour after administration

    Time frame: 1 hour after administration

    Calculated based on glucose concentration measured in plasma.

  18. Plasma glucose concentration 2 hours after administration

    Time frame: 2 hours after administration

    Calculated based on glucose concentration measured in plasma.

  19. Maximum plasma glucose excursion after administration

    Time frame: 0-6 hours

    Calculated based on glucose concentration measured in plasma.

  20. Maximum plasma glucose concentration after administration

    Time frame: 0-6 hours

    Calculated based on glucose concentration measured in plasma.

  21. Time to maximum plasma glucose concentration after administration

    Time frame: 0-6 hours

    Calculated based on glucose concentration measured in plasma.

  22. Minimum plasma glucose concentration after administration

    Time frame: 0-6 hours

    Calculated based on glucose concentration measured in plasma.

  23. Number of adverse events

    Time frame: From screening day 1 up to the study completion day 68

    Count of events

  24. Number of hypoglycaemic episodes

    Time frame: From screening day 1 up to the study completion day 68

    Count of hypoglycaemic episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2018
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.