NCT03444467

First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.

A Randomised, Double-blinded, Single Subcutaneous Dose Escalation Trial Investigating the Safety and Tolerability of NNC9204-1513 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Diabetes
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	NNC9204-1513	Participants will receive NNC9204-1513 subcutaneous (s.c., in to a skin fold on the stomach) injection as single increasing doses of 0.01 mg, 0.04 mg, 0.10 mg, 0.25 mg, 0.50 mg, 1.0 mg or 2.0 mg. Each participant will only be given one dose. Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.
DRUG	Glucagon	Participants will receive single dose of 1 mg glucagon s.c. injection.
DRUG	Placebo	Participants will receive single dose of placebo (for double dummy injections).

Timeline

• Start date: 2018-02-05
• Primary completion: 2018-05-24
• Completion: 2018-05-24
• First posted: 2018-02-23
• Last updated: 2018-09-05

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study