NCT04575181

A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine

A Multiple Dose, Randomised, Double Blinded, Double Dummy Trial Investigating Efficacy and Safety of NNC0268-0965 Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will look at the efficacy and safety of NNC0268-0965 (referred to as insulin 965). The study aims to show that insulin 965 has positive effects on the blood vessels. Participants will get either the new insulin 965 or insulin glargine - a medicine that doctors already can prescribe (Lantus®). Which treatment participants get is decided by chance. Participants will self-administer 2 injections per day under the skin of the thighs for 26 weeks. Study participation will last for about 32 weeks. Participants will have 15 clinic visits, 2 magnetic resonance imaging (MRI) visits and 14 phone calls with the study doctor. There will be a number of in-house assessments to study the effect of the new insulin. The assessments will be explained later in detail. The treatment of disease is not an aim of this study. Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are not able to become pregnant.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	NNC0268-0965	For subcutaneous (s.c., under the skin) injection once daily for 26 weeks
DRUG	Insulin glargine	For s.c. injection once daily for 26 weeks
DRUG	Placebo (NNC0268-0965)	For s.c. injection once daily for 26 weeks
DRUG	Placebo (insulin glargine)	For s.c. injection once daily for 26 weeks

Timeline

• Start date: 2020-10-21
• Primary completion: 2021-12-10
• Completion: 2021-12-24
• First posted: 2020-10-05
• Last updated: 2024-01-10

Locations

2 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study