A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic Properties of Fast-acting Insulin Aspart in Chinese Subjects With Type 1 Diabetes or Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04698018
• Other study ID #: NN1218-4316
• Secondary ID: U1111-1199-1934
• Status: Completed
• Phase: Phase 1
• Start date: April 20, 2021
• Est. completion date: April 25, 2023

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study looks at how faster aspart reaches and stays in the blood after injection in Chinese people with type 1 diabetes or type 2 diabetes, compared to the reference product called NovoRapid®. Participants will get both faster aspart and NovoRapid®. The order in which Participants get them is decided by chance. Participants will get each study medicine once during the study meaning that they will get a total of 2 injections with study medicines. The medicine will be injected under the skin of the lower abdomen. The study will last for about 19-72 days. Participants will have 5 clinic visits with the study doctor (including the one in which participants give their consent). Participants will need to stay overnight for 2 of the 5 clinic visits. Participants will have blood samples taken during some of the clinic visits. During the visits where participants get the study medicines, samples of their blood will be taken several times for up to 12 hours after getting the study medicine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

For a subject with type 1 diabetes mellitus:

• Male or female Chinese subjects aged 18-64 years (both inclusive) at the time of signing informed consent.
• Type 1 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening.
• Treated with multiple daily insulin injections or premix insulin greater than or equal to 12 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (CSII) greater than or equal to 3 months prior to the day of screening.
• Glycosylated haemoglobin (HbA1c) less than or equal to 9.0 percent (75 mmol/mol) by central laboratory analysis.

For a subject with type 2 diabetes mellitus:

• Male or female Chinese subjects aged 18-75 years (both inclusive) at the time of signing informed consent.
• Type 2 diabetes mellitus (as diagnosed clinically) greater than or equal to 12 months prior to the day of screening.
• Treated with multiple daily insulin injections or premix insulin greater than or equal to 6 months prior to the day of screening or treated with continuous subcutaneous insulin infusion (CSII) greater than or equal to 3 months prior to the day of screening.
• Glycosylated haemoglobin less than or equal to 9.5 percent (80 mmol/mol) by central laboratory analysis. Exclusion criteria:

For a subject with type 1 diabetes mellitus or type 2 diabetes mellitus:

• Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
• Surgery or trauma with significant blood loss (more than 400 mL) within the last 3 months prior to screening.
• Not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Faster Aspart
Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
• Novo Rapid
Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss
Hong Kong	Phase 1 Clinical Trial Centre	Shatin, New Territories
Hong Kong	Phase 1 Clinical Trial Centre	Shatin, New Territories, Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes	pmol·h/L	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve from 0 to 15 minutes	pmol·h/L	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	AUCIAsp,0-1h, area under the serum insulin aspart concentration-time curve from 0 to 1 hour	pmol·h/L	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	AUCIAsp,0-1½h, area under the serum insulin aspart concentration-time curve from 0 to 1½ hours	pmol·h/L	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	AUCIAsp,0-2h, area under the serum insulin aspart concentration-time curve from 0 to 2 hours	pmol·h/L	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	AUCIAsp,0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours	pmol·h/L	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	Cmax,IAsp, maximum observed serum insulin aspart concentration	pmol/L	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	tmax,IAsp, time to maximum observed serum insulin aspart concentration	Minutes	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	Onset of appearanceIAsp, time from trial product administration until the first time serum insulin aspart concentration greater than or equal to lower limit of quantification (LLOQ)	Minutes	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	Time to 50 percent Cmax, IAsp, the first time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp	Minutes	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	Time to late 50 percent Cmax,IAsp, the last time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp	Minutes	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	t½, terminal half-life for insulin aspart	Minutes	0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2)
Secondary	Number of treatment emergent adverse events	Count of Events	Until 7 days after IMP (investigational medicinal product) administration
Secondary	Number of treatment emergent hypoglycaemic episodes	Count of Episodes	No longer than 16 hours after IMP administration until next administration of insulin (non-investigational medicinal product (NIMP) or subject's pre-trial insulin)