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

Study Overview
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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®.

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

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Faster aspart
* Drug: Insulin aspart (NovoRapid®)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Faster aspart followed by insulin aspart (NovoRapid®)<br>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<br>* An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.<br>Drug: Insulin aspart (NovoRapid®)<br>* An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.<br>|
| Experimental: Insulin aspart (NovoRapid®) followed by faster aspart<br>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<br>* An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.<br>Drug: Insulin aspart (NovoRapid®)<br>* An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.<br>|

What is the study measuring?
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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 |