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

NCT ID: NCT03444467

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2018-05-24

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NNC9204-1513

Participants will receive increasing doses of NNC9204-1513.

Group Type: EXPERIMENTAL

NNC9204-1513

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Participants will receive single dose of placebo (for double dummy injections).

Glucagon

Participants will receive a single fixed dose of glucagon.

Group Type: ACTIVE_COMPARATOR

Glucagon

Intervention Type: DRUG

Participants will receive single dose of 1 mg glucagon s.c. injection.

Placebo

Intervention Type: DRUG

Participants will receive single dose of placebo (for double dummy injections).

Interventions

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.

Intervention Type: DRUG

Glucagon

Participants will receive single dose of 1 mg glucagon s.c. injection.

Intervention Type: DRUG

Placebo

Participants will receive single dose of placebo (for double dummy injections).

Intervention Type: DRUG

Other Intervention Names

GlucaGen®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

U1111-1180-8217

Identifier Type: OTHER

Identifier Source: secondary_id

2016-001173-33

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9513-4290

Identifier Type: -

Identifier Source: org_study_id