Clinical trial NCT03444467: First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.
Official title: A Randomised, Double-blinded, Single Subcutaneous Dose Escalation Trial Investigating the Safety and Tolerability of NNC9204-1513 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: from time of dosing (day 1) to completion of the safety follow-up visit (day 8)
Secondary outcomes:
measure: Change from baseline in haematology
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in biochemistry
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in fibrinogen
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in lipids
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in glucose metabolism
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in hormones
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in urine dipstick parameter
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in systolic- and diastolic blood pressure
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in body temperature
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in respiration rate
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in 12-lead electrocardiogram (ECG) heart rate
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in 12-lead ECG (RR interval)
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in 12-lead ECG (PR interval)
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in 12-lead ECG (QRS interval)
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in 12-lead ECG (QT interval)
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in 12-lead ECG (QTc intervals [Fridericia])
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in Physical examination
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Incidence of injection site reactions
timeFrame: After administration of the trial products (day 1) until completion of the post-treatment follow-up visit (day 8).
measure: AUC0-15min,SD, area under the plasma concentration time curve
timeFrame: 0 to 15 minutes after single dose
measure: t1/2,SD, terminal half-life
timeFrame: Measured for 24 hours after administration of a single s.c. dose
measure: Onset of appearance
timeFrame: Measured for 24 hours after administration of a single s.c. dose
measure: AUCPG,0-15min,SD, area under the plasma glucose time curve
timeFrame: 0 to 15 minutes after single dose
measure: ΔPG0-15min,SD, Increase in plasma glucose concentration from 0 to 15 minutes
timeFrame: 0 to 15 minutes after single dose
measure: Change from baseline in 12-lead ECG (overall evaluation)
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in prothrombin time
timeFrame: baseline (day 1), follow-up visit (day 8)
measure: Change from baseline in Activated Partial Thromboplastin time (APTT)
timeFrame: baseline (day 1), follow-up visit (day 8)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: