NCT03965013

A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0268-0965 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is investigating the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. This first part of the study is conducted in healthy people, while there is a second part involving people with type 1 diabetes. The study will test how insulin 965 is tolerated by the participants' body, how it is taken up in the participants' blood, how long it stays there and how blood sugar is lowered. Participants will either get the new insulin 965 or placebo (an injection that does not contain active medicine) - which treatment you get is decided by chance. It is the first time that insulin 965 is tested in humans. Participants will get one injection of either insulin 965 or placebo under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. People cannot be in the study if the study doctor thinks that there are risks for their health.

Conditions

• Diabetes Mellitus, Type 1
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	NNC0268-0965	2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2
DRUG	Placebo	A single dose of placebo given in Part 1
DRUG	insulin glargine	Insulin glargine given at a fixed dose level of 0.5 U/kg

Timeline

• Start date: 2019-06-05
• Primary completion: 2019-12-14
• Completion: 2019-12-14
• First posted: 2019-05-28
• Last updated: 2021-01-14

Locations

1 site across 1 country: Germany