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A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Study Investigating the Pharmacokinetic Properties of a Single Dose of IcoSema Compared With Insulin Icodec and Semaglutide Given Separately in Chinese Participants With Type 2 Diabetes

Clinical Trial Summary

This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes. IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide. Insulin icodec is a possible new medicine. That means that the medicine has not yet been approved by the authorities. Semaglutide is a medicine already approved by the authorities in the EU, USA, China and Japan. The study will look at the way insulin icodec and semaglutide reach and stay in participants blood after injection when given together as IcoSema or alone as insulin icodec and semaglutide. Participants will get each of the 3 medicines (IcoSema, insulin icodec and semaglutide) at 3 different timepoints: The order in which participants get them is decided by chance. Participants will get the 3 medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks. The study will last for about 19 to 26 weeks. Participants will have 31 or 32 visits to the clinic. 3 of the visits will be in-house visits, meaning that participants will stay at the clinic for 5 or 6 days (4 or 5 nights). Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05435677
Study type Interventional
Source Novo Nordisk A/S
Contact
Status Completed
Phase Phase 1
Start date June 22, 2022
Completion date April 25, 2023
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