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NCT Number: NCT04698018

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Faster Aspart

Drug

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

Novo Rapid

Drug

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

Primary outcomes

  1. AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes

    Time frame: 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)

    pmol·h/L

Secondary outcomes

  1. AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve from 0 to 15 minutes

    Time frame: 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)

    pmol·h/L

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

    Time frame: 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)

    pmol·h/L

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

    Time frame: 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)

    pmol·h/L

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

    Time frame: 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)

    pmol·h/L

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

    Time frame: 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)

    pmol·h/L

  6. Cmax,IAsp, maximum observed serum insulin aspart concentration

    Time frame: 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)

    pmol/L

  7. tmax,IAsp, time to maximum observed serum insulin aspart concentration

    Time frame: 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)

    Minutes

  8. 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)

    Time frame: 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)

    Minutes

  9. Time to 50 percent Cmax, IAsp, the first time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp

    Time frame: 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)

    Minutes

  10. Time to late 50 percent Cmax,IAsp, the last time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp

    Time frame: 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)

    Minutes

  11. t½, terminal half-life for insulin aspart

    Time frame: 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)

    Minutes

  12. Number of treatment emergent adverse events

    Time frame: Until 7 days after IMP (investigational medicinal product) administration

    Count of Events

  13. Number of treatment emergent hypoglycaemic episodes

    Time frame: No longer than 16 hours after IMP administration until next administration of insulin (non-investigational medicinal product (NIMP) or subject's pre-trial insulin)

    Count of Episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2021
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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