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

NCT04698018 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN1218-4316U1111-1199-1934
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve from 0 to 15 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)

• AUCIAsp,0-1h, area under the serum insulin aspart concentration-time curve from 0 to 1 hour

  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)

• AUCIAsp,0-1½h, area under the serum insulin aspart concentration-time curve from 0 to 1½ hours

  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)

• AUCIAsp,0-2h, area under the serum insulin aspart concentration-time curve from 0 to 2 hours

  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)

• AUCIAsp,0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours

  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)

Study Arms (2)

Faster aspart

EXPERIMENTAL

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.

Drug: Faster Aspart

NovoRapid®

ACTIVE COMPARATOR

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.

Drug: Novo Rapid

Interventions

Novo Rapid DRUG

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

NovoRapid®

Faster Aspart DRUG

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

Faster aspart

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (3)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Phase 1 Clinical Trial Centre

Shatin, New Territories, Hong Kong, Postal Code: NA, Hong Kong

Location

Phase 1 Clinical Trial Centre

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Transparency (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 6, 2021
• Study Start: April 20, 2021
• Primary Completion: July 20, 2022
• Study Completion: July 22, 2022
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); HK (2)