This study looks at the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentration in the blood and its effect on the blood sugar for the treatment of diabetes. The study will test how insulin 965 is tolerated by the body, how it is taken up in the blood, how long it stays there and how the blood sugar is lowered. Participants will either get the new insulin 965 or the already marketed insulin glargine U100 (Lantus®) - which treatment is decided by chance. Participants will get six injections (one per day) of either insulin 965 or insulin glargine U100 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. Participants can only be in the study if the study doctor thinks that there are no risks for their health. Women can only take part in the study if they can't have children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
One daily dose of 1.5, 4.0 or 6.0 nmol/kg administered s.c. (subcutaneously, under the skin) for 6 days
One daily dose of 3.0 nmol/kg administered s.c. for 6 days
Novo Nordisk Investigational Site
Neuss, Germany
Number of treatment-emergent adverse events (AEs)
Number of events
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)
Number of treatment-emergent hypoglycaemic episodes
Number of episodes
Time frame: From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)
Area under the serum NNC0268-0965 concentration-time curve during one dosing interval at steady state
pmol\*h/l
Time frame: From 0 to 24 hours after IMP administration at day 6 (visit 2)
Maximum observed serum NNC0268-0965 concentration after the last dose
pmol/l
Time frame: From 0 to 24 hours after IMP administration at day 6 (visit 2)
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