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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: NNC9204-1513; Drug: Glucagon; Drug: Placebo

• Registration Number: NCT03444467
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-05
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-23
• Primary Completion: 2018-05-24
• Study Completion: 2018-05-24
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC9204-1513	NNC9204-1513	Participants will receive increasing doses of NNC9204-1513.
NNC9204-1513	Placebo	Participants will receive increasing doses of NNC9204-1513.
Glucagon	Placebo	Participants will receive a single fixed dose of glucagon.
Glucagon	Glucagon	Participants will receive a single fixed dose of glucagon.

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	from time of dosing (day 1) to completion of the safety follow-up visit (day 8)	Count of events

Secondary Outcome Measures

Name	Time	Method
Change from baseline in body temperature	baseline (day 1), follow-up visit (day 8)
Change from baseline in haematology	baseline (day 1), follow-up visit (day 8)
Change from baseline in biochemistry	baseline (day 1), follow-up visit (day 8)
Change from baseline in glucose metabolism	baseline (day 1), follow-up visit (day 8)
Change from baseline in Physical examination	baseline (day 1), follow-up visit (day 8)
Incidence of injection site reactions	After administration of the trial products (day 1) until completion of the post-treatment follow-up visit (day 8).
Change from baseline in fibrinogen	baseline (day 1), follow-up visit (day 8)	measured in g/L
Change from baseline in lipids	baseline (day 1), follow-up visit (day 8)
Change from baseline in systolic- and diastolic blood pressure	baseline (day 1), follow-up visit (day 8)	Measured in mm Hg
Change from baseline in respiration rate	baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead electrocardiogram (ECG) heart rate	baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (RR interval)	baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (PR interval)	baseline (day 1), follow-up visit (day 8)
AUC0-15min,SD, area under the plasma concentration time curve	0 to 15 minutes after single dose
t1/2,SD, terminal half-life	Measured for 24 hours after administration of a single s.c. dose
Onset of appearance	Measured for 24 hours after administration of a single s.c. dose	Time from trial product administration until first time plasma concentration ≥ lower limit of quantification (LLOQ)
AUCPG,0-15min,SD, area under the plasma glucose time curve	0 to 15 minutes after single dose
ΔPG0-15min,SD, Increase in plasma glucose concentration from 0 to 15 minutes	0 to 15 minutes after single dose	Calculated as: Plasma glucose concentration at 15 minutes after single dose minus plasma glucose concentration at 0 minute
Change from baseline in 12-lead ECG (overall evaluation)	baseline (day 1), follow-up visit (day 8)
Change from baseline in hormones	baseline (day 1), follow-up visit (day 8)
Change from baseline in urine dipstick parameter	baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (QRS interval)	baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (QTc intervals [Fridericia])	baseline (day 1), follow-up visit (day 8)	QT interval corrected for heart rate by Fridericia's formula
Change from baseline in 12-lead ECG (QT interval)	baseline (day 1), follow-up visit (day 8)
Change from baseline in prothrombin time	baseline (day 1), follow-up visit (day 8)	measured in seconds
Change from baseline in Activated Partial Thromboplastin time (APTT)	baseline (day 1), follow-up visit (day 8)	measured in seconds

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany