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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: NNC9204-1513; Drug: Glucagon; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03444467

NN9513-4290

2016-001173-33 (Registry Identifier)

U1111-1180-8217 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male, aged 18 -55 years (both inclusive), at the time of signing informed consent
• Body mass index (BMI) between 18.5 and 28.0 kg/sqm (both inclusive)
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

• Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
• Smoker (defined as a subject who is smoking at least one cigarette or equivalent daily) who is not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
• Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

NNC9204-1513

Experimental group

Description:

Participants will receive increasing doses of NNC9204-1513.

Treatment:

Drug: Placebo

Drug: NNC9204-1513

Glucagon

Active Comparator group

Description:

Participants will receive a single fixed dose of glucagon.

Treatment:

Drug: Placebo

Drug: Glucagon