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

NCT ID: NCT04698018

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2022-07-22

Brief 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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Faster aspart

Subjects will receive 2 injections of a single dose of faster aspart at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes.

Group Type: EXPERIMENTAL

Faster Aspart

Intervention Type: DRUG

Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.

NovoRapid®

Subjects will receive 2 injections of a single dose of NovoRapid® at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes.

Group Type: ACTIVE_COMPARATOR

Novo Rapid

Intervention Type: DRUG

Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.

Interventions

Faster Aspart

Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.

Intervention Type: DRUG

Novo Rapid

Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Phase 1 Clinical Trial Centre

Shatin, New Territories, Hong Kong, , Hong Kong

Phase 1 Clinical Trial Centre

Shatin, New Territories, , Hong Kong

Countries

Germany; Hong Kong

Other Identifiers

U1111-1199-1934

Identifier Type: OTHER

Identifier Source: secondary_id

NN1218-4316

Identifier Type: -

Identifier Source: org_study_id