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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407599
• Other study ID #: NN1218-4371
• Secondary ID: 2017-002014-31U1
• Status: Completed
• Phase: Phase 1
• Start date: January 8, 2018
• Est. completion date: July 5, 2018

Study information

• Verified date: June 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 5, 2018
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cmax,IAsp, maximum observed serum insulin aspart concentration	Calculated based on insulin aspart measured in blood.	0-12 hours
Secondary	tmax,IAsp, time to maximum observed serum insulin aspart concentration	Calculated based on insulin aspart measured in blood.	0-12 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean change in plasma glucose concentration from 0-1 hour after administration	Calculated based on glucose concentration measured in plasma.	0-1 hour
Secondary	Mean change in plasma glucose concentration from 0-2 hours after administration	Calculated based on glucose concentration measured in plasma.	0-2 hours
Secondary	Mean change in plasma glucose concentration from 0-6 hours after administration	Calculated based on glucose concentration measured in plasma.	0-6 hours
Secondary	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
Secondary	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
Secondary	Plasma glucose concentration 1 hour after administration	Calculated based on glucose concentration measured in plasma.	1 hour after administration
Secondary	Plasma glucose concentration 2 hours after administration	Calculated based on glucose concentration measured in plasma.	2 hours after administration
Secondary	Maximum plasma glucose excursion after administration	Calculated based on glucose concentration measured in plasma.	0-6 hours
Secondary	Maximum plasma glucose concentration after administration	Calculated based on glucose concentration measured in plasma.	0-6 hours
Secondary	Time to maximum plasma glucose concentration after administration	Calculated based on glucose concentration measured in plasma.	0-6 hours
Secondary	Minimum plasma glucose concentration after administration	Calculated based on glucose concentration measured in plasma.	0-6 hours
Secondary	Number of adverse events	Count of events	From screening day 1 up to the study completion day 68
Secondary	Number of hypoglycaemic episodes	Count of hypoglycaemic episodes	From screening day 1 up to the study completion day 68