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®.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Faster aspart; Drug: Insulin aspart (NovoRapid®)

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30173
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 64 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours	Calculated based on insulin aspart measured in blood.	0-12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes	Calculated based on insulin aspart measured in blood.	0-15 minutes
AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes	Calculated based on insulin aspart measured in blood.	0-30 minutes
AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour	Calculated based on insulin aspart measured in blood.	0-1 hour
AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour	Calculated based on insulin aspart measured in blood.	0-1½ hour
AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours	Calculated based on insulin aspart measured in blood.	0-2 hours
Cmax,IAsp, maximum observed serum insulin aspart concentration	Calculated based on insulin aspart measured in blood.	0-12 hours
tmax,IAsp, time to maximum observed serum insulin aspart concentration	Calculated based on insulin aspart measured in blood.	0-12 hours
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)	Calculated based on insulin aspart measured in blood.	0-12 hours
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	Calculated based on insulin aspart measured in blood.	0-12 hours
Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp	Calculated based on insulin aspart measured in blood.	0-12 hours
Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp	Calculated based on insulin aspart measured in blood.	0-12 hours
Mean change in plasma glucose concentration from 0-1 hour after administration	Calculated based on glucose concentration measured in plasma.	0-1 hour
Mean change in plasma glucose concentration from 0-2 hours after administration	Calculated based on glucose concentration measured in plasma.	0-2 hours
Mean change in plasma glucose concentration from 0-6 hours after administration	Calculated based on glucose concentration measured in plasma.	0-6 hours
Change from baseline in plasma glucose concentration 1 hour after administration	Calculated based on glucose concentration measured in plasma.	Pre-dose (0 hour), 1 hour
Change from baseline in plasma glucose concentration 2 hours after administration	Calculated based on glucose concentration measured in plasma.	Pre-dose (0 hour), 2 hours
Plasma glucose concentration 1 hour after administration	Calculated based on glucose concentration measured in plasma.	1 hour after administration
Plasma glucose concentration 2 hours after administration	Calculated based on glucose concentration measured in plasma.	2 hours after administration
Maximum plasma glucose excursion after administration	Calculated based on glucose concentration measured in plasma.	0-6 hours
Maximum plasma glucose concentration after administration	Calculated based on glucose concentration measured in plasma.	0-6 hours
Time to maximum plasma glucose concentration after administration	Calculated based on glucose concentration measured in plasma.	0-6 hours
Minimum plasma glucose concentration after administration	Calculated based on glucose concentration measured in plasma.	0-6 hours
Number of adverse events	Count of events	From screening day 1 up to the study completion day 68
Number of hypoglycaemic episodes	Count of hypoglycaemic episodes	From screening day 1 up to the study completion day 68

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): July 5, 2018
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
• Other Study ID Numbers: NN1218-4371; 2017-002014-31 (Registry Identifier: European Medicines Agency (EudraCT)); U1111-1197-0428 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes