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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2
A single dose of placebo given in Part 1
Insulin glargine given at a fixed dose level of 0.5 U/kg
Novo Nordisk Investigational Site
Neuss, Germany
Number of treatment-emergent adverse events
Number of events
Time frame: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Number of treatment-emergent hypoglycaemic episodes
Number of episodes
Time frame: From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10
Area under the serum NNC0268-0965 concentration-time curve after a single dose
pmol\*h/L
Time frame: From 0 hours until infinity after trial product administration (day 1)
Maximum observed serum NNC0268-0965 concentration after a single dose
pmol/L
Time frame: From 0 hours until last measurement time after trial product administration (day 1)
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