drugset / Trial / NCT04698018

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

NCT04698018

Phase 1 Completed 23 enrolled Novo Nordisk A/S
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2021-04-20
Primary completion
2022-07-20
Completion
2022-07-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Faster aspart Unknown 0.2 iu/kg Subcutaneous
Subject Faster aspart Unknown 0.3 iu/kg Subcutaneous
Comparator insulin aspart Protein / enzyme biologic 0.2 iu/kg Subcutaneous
Comparator insulin aspart Protein / enzyme biologic 0.3 iu/kg Subcutaneous