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CompletedNCT04698018

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Novo Nordisk A/S · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGFaster AspartAdministered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
DRUGNovo RapidAdministered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.

Timeline

Start date
2021-04-20
Primary completion
2022-07-20
Completion
2022-07-22
First posted
2021-01-06
Last updated
2025-12-04

Locations

3 sites across 2 countries: Germany, Hong Kong

Regulatory

Source: ClinicalTrials.gov record NCT04698018. Inclusion in this directory is not an endorsement.