This study is testing a new medicine that might help treat people with type 2 diabetes. The study is conducted to see if the new medicine can lower high sugar levels in the blood. The purpose of the study is to see if the new study medicine is safe and how well is tolerated by the body. There will be two groups of partici-pants in this study: healthy participants and participants with type 2 diabetes. Participant will either get study medicine (NNC9733-0001) or placebo (a treatment that has no active medicine in it). Which treatment the participant gets is decided by chance. Which dose (strength) the participant get is determined by when participant enter the study. Participant will get one dose which will be injected into the area around abdomen (belly) by the medical staff. The number of injections (up to 4 injections) will depend on the group the participant is assigned to. Larger doses require multiple injections. The study will last for about 40 weeks (10 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Administered a single dose of NNC9733-0001.
Administered a single dose of matching NNC9733-0001 placebo.
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
RECRUITINGNumber of treatment emergent adverse events (TEAEs)
Measured as number of events
Time frame: From dosing (day 1) until end of study (EOS) visit (week 36)
Number of hypoglycaemic episodes
Measured as number of episodes
Time frame: From dosing (day 1) until end of study (EOS) visit (week 36)
AUC0-last,SD: The area under the NNC9733-0001 plasma concentration-time curve from time zero to last measured concentration above LLQO after a single dose
Measured in hours × nanogram/millilitre (ng/mL)
Time frame: From dosing (day 1) to 48 hours after dosing
Cmax: The maximum concentration of NNC9733-0001 in plasma
Measured in nanogram/millilitre (ng/mL)
Time frame: From dosing (day 1) to 48 hours after dosing
tmax, SD: The time from dose administration to maximum plasma concentration of NNC9733-0001
Measured in hours
Time frame: From dosing (day 1) to 48 hours after dosing
t1/2, SD: Terminal half-life for NNC9733-0001 after a single dose
Measured in hours
Time frame: From dosing (day 1) to 48 hours after dosing
CLR,SD: Renal clearance of NNC9733 0001
Measured in litre/hour
Time frame: From dosing (day 1) to 48 hours after dosing
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