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

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source 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®.

Overall Status Completed
Start Date January 8, 2018
Completion Date July 5, 2018
Primary Completion Date July 5, 2018
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours 0-12 hours
Secondary Outcome
Measure Time Frame
AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes 0-15 minutes
AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes 0-30 minutes
AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour 0-1 hour
AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour 0-1½ hour
AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours 0-2 hours
Cmax,IAsp, maximum observed serum insulin aspart concentration 0-12 hours
tmax,IAsp, time to maximum observed serum insulin aspart concentration 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) 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 0-12 hours
Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp 0-12 hours
Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp 0-12 hours
Mean change in plasma glucose concentration from 0-1 hour after administration 0-1 hour
Mean change in plasma glucose concentration from 0-2 hours after administration 0-2 hours
Mean change in plasma glucose concentration from 0-6 hours after administration 0-6 hours
Change from baseline in plasma glucose concentration 1 hour after administration Pre-dose (0 hour), 1 hour
Change from baseline in plasma glucose concentration 2 hours after administration Pre-dose (0 hour), 2 hours
Plasma glucose concentration 1 hour after administration 1 hour after administration
Plasma glucose concentration 2 hours after administration 2 hours after administration
Maximum plasma glucose excursion after administration 0-6 hours
Maximum plasma glucose concentration after administration 0-6 hours
Time to maximum plasma glucose concentration after administration 0-6 hours
Minimum plasma glucose concentration after administration 0-6 hours
Number of adverse events From screening day 1 up to the study completion day 68
Number of hypoglycaemic episodes From screening day 1 up to the study completion day 68
Enrollment 46
Condition
Intervention

Intervention Type: Drug

Intervention Name: Faster aspart

Description: An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.

Intervention Type: Drug

Intervention Name: Insulin aspart (NovoRapid®)

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

Eligibility

Criteria:

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

Gender: All

Minimum Age: 6 Years

Maximum Age: 64 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Reporting Anchor and Disclosure (1452) Study Director Novo Nordisk A/S
Location
Facility: Novo Nordisk Investigational Site
Location Countries

Germany

Verification Date

June 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Faster aspart followed by insulin aspart (NovoRapid®)

Type: Experimental

Description: 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.

Label: Insulin aspart (NovoRapid®) followed by faster aspart

Type: Experimental

Description: 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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Source: ClinicalTrials.gov