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

November 27, 2025 updated by: Novo Nordisk A/S

A Trial Investigating the Pharmacokinetic Properties of Fast-acting Insulin Aspart in Chinese Subjects 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH
  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Phase 1 Clinical Trial Centre
      • Shatin, New Territories, Hong Kong, Hong Kong, Postal Code: NA
        • Phase 1 Clinical Trial Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Faster Aspart
Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
Active Comparator: 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.
Drug: Novo Rapid
Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
Number of treatment emergent adverse events
Time Frame: Until 7 days after IMP (investigational medicinal product) administration
Count of Events
Until 7 days after IMP (investigational medicinal product) administration
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
No longer than 16 hours after IMP administration until next administration of insulin (non-investigational medicinal product (NIMP) or subject's pre-trial insulin)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN1218-4316
  • U1111-1199-1934 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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