Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomised, Double-blinded, Single Subcutaneous Dose Escalation Trial Investigating the Safety and Tolerability of NNC9204-1513 in Healthy Subjects
The study is comparing the new medicine NNC9204-1513 with a standard therapy of glucagon
(GlucaGen®). This is the first time NNC9204-1513 is given to humans.
Participants will either receive NNC9204-1513 or GlucaGen® - which treatment you get is
decided by chance (like flipping a coin). Neither the participant nor the study doctor will
know which study medicine (NNC9204-1513 or GlucaGen®) the participant is receiving (double
-blinding). In case of emergency, this information will be readily available.
NNC9204-1513 is a new medicine for rescue treatment of severe low blood sugar and currently
not available on the market (doctors cannot prescribe this medicine). The participant will
receive two or three single injections below the skin. One injection will contain
NNC9204-1513 or GlucaGen®. The other injection will include placebo - this is a product that
looks like the actual study drug but without any active ingredients. If a third injection is
given, this will contain NNC9204-1513 or placebo. NNC9204-1513 and GlucaGen® will be given
using different devices and volumes. In order to mask these external differences, a "double
dummy" approach will be used, that means when you get either of the study medicine
(NNC9204-1513 or GlucaGen®) you will get another injection which contains no medicine called
'placebo' (it will not have any effect on the body). Dependent on the injection volume to be
administered, injections are given by either syringe with needle or an injection pen (NovoPen
Echo®). The study will last for up to 39 days.
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