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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes
• Interventions: Drug: Faster aspart; Drug: Insulin aspart (NovoRapid®)

• Registration Number: NCT03407599
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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®.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-05
• Study Start: 2018-01-08
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-23
• Primary Completion: 2018-07-05
• Study Completion: 2018-07-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin aspart (NovoRapid®) followed by faster aspart	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.
Faster aspart followed by insulin aspart (NovoRapid®)	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.
Faster aspart followed by insulin aspart (NovoRapid®)	Faster aspart	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.
Insulin aspart (NovoRapid®) followed by faster aspart	Insulin aspart (NovoRapid®)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Hannover, Germany