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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes; Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: NNC9204-1513; Drug: Placebo; Drug: Glucagon

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC9204-1513; Participants will receive increasing doses of NNC9204-1513.	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: Placebo; Participants will receive single dose of placebo (for double dummy injections).
Active Comparator: Glucagon; Participants will receive a single fixed dose of glucagon.	Drug: Placebo; Participants will receive single dose of placebo (for double dummy injections).; Drug: Glucagon; Participants will receive single dose of 1 mg glucagon s.c. injection.; Other Names: GlucaGen®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 fibrinogen	measured in g/L	baseline (day 1), follow-up visit (day 8)
Change from baseline in lipids		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 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 systolic- and diastolic blood pressure	Measured in mm Hg	baseline (day 1), follow-up visit (day 8)
Change from baseline in body temperature		baseline (day 1), follow-up visit (day 8)
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)
Change from baseline in 12-lead ECG (QRS interval)		baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (QT interval)		baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (QTc intervals [Fridericia])	QT interval corrected for heart rate by Fridericia's formula	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).
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	Time from trial product administration until first time plasma concentration ≥ lower limit of quantification (LLOQ)	Measured for 24 hours after administration of a single s.c. dose
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	Calculated as: Plasma glucose concentration at 15 minutes after single dose minus plasma glucose concentration at 0 minute	0 to 15 minutes after single dose
Change from baseline in 12-lead ECG (overall evaluation)		baseline (day 1), follow-up visit (day 8)
Change from baseline in prothrombin time	measured in seconds	baseline (day 1), follow-up visit (day 8)
Change from baseline in Activated Partial Thromboplastin time (APTT)	measured in seconds	baseline (day 1), follow-up visit (day 8)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): May 24, 2018
• Study Completion (Actual): May 24, 2018

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glucagon
• Other Study ID Numbers: NN9513-4290; U1111-1180-8217 (Other Identifier: World Health Organization (WHO)); 2016-001173-33 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes