A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic Properties of Five Formulations of Fast-acting Insulin Aspart 200 U/mL in Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723759
• Other study ID #: NN1200-4431
• Secondary ID: U1111-1209-20992
• Status: Completed
• Phase: Phase 1
• Start date: October 26, 2018
• Est. completion date: March 27, 2019

Study information

• Verified date: March 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is looking at how five different formulations of faster aspart 200 U/mL reach and stay in the blood after injection. The purpose is to find a formulation that behaves similarly to the reference product called faster aspart 100 U/mL (marketed as Fiasp®). The participant will get all five formulations and the reference product. The order in which the participant gets them is decided by chance. The participant will get each medicine once during the study meaning that the participant will get a total of six injections with study medicine. The medicine will be injected under the skin in the stomach. The study will last for about 2 to 21 weeks depending on individual visit schedule. The participant will have nine clinic visits with the study doctor (including the one in which the participant give consent).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 27, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent

• Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening

• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion greater than or equal to 1 year prior to the day of screening

Exclusion Criteria:

• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening in this trial

• Blood donation, plasma donation or blood draw, defined as any of the below: In excess of 400 mL within the past 90 days prior to the day of screening OR In excess of 50 mL within the past 30 days prior to the day of screening

• Use of tobacco and nicotine products, defined as any of the below: Smoking more than 1 cigarette or the equivalent per day OR Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house periods

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Faster Aspart 200 U/mL
A single dose (0.15 U/kg) of five formulations of fast-acting insulin aspart 200 U/mL (formulations A, B, C, D, E) in a sequential manner via subcutaneous injection.
• Faster aspart 100 U/mL
A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

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	AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure	Measured in pmol*h/L	0 to 10 hours after IMP administration
Secondary	AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration	Measured in pmol*h/L	0 to 1 hour after IMP administration
Secondary	AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration	Measured in pmol*h/L	0 to 2 hours after IMP administration
Secondary	AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity	Measured in pmol*h/L	0 to 10 hours after IMP administration
Secondary	Cmax,IAsp - Maximum observed serum insulin aspart concentration	Measured in pmol/L	0 to 10 hours after IMP administration
Secondary	tmax,IAsp - Time to maximum observed serum insulin aspart concentration	Measured in minutes	0 to 10 hours after IMP administration
Secondary	Number of adverse events in the treatment emergent period	Count of events	0 to 2 days after IMP administration
Secondary	Number of local reactions at the injection site in the treatment emergent period	Count of injection site reactions	0 to 2 days after IMP administration
Secondary	Number of hypoglycaemic episodes in the treatment emergent period	Count of hypoglycaemic episodes	0 to 16 hours after IMP administration