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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomised, Double-blinded, Single Subcutaneous Dose Escalation Trial Investigating the Safety and Tolerability of NNC9204-1513 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444467
• Other study ID #: NN9513-4290
• Secondary ID: U1111-1180-82172
• Status: Completed
• Phase: Phase 1
• Start date: February 5, 2018
• Est. completion date: May 24, 2018

Study information

• Verified date: September 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 24, 2018
• Est. primary completion date: May 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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.
• Glucagon
Participants will receive single dose of 1 mg glucagon s.c. injection.
• Placebo
Participants will receive single dose of placebo (for double dummy injections).

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in haematology		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in biochemistry		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in fibrinogen	measured in g/L	baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in lipids		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in glucose metabolism		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in hormones		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in urine dipstick parameter		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in systolic- and diastolic blood pressure	Measured in mm Hg	baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in body temperature		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in respiration rate		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in 12-lead electrocardiogram (ECG) heart rate		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in 12-lead ECG (RR interval)		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in 12-lead ECG (PR interval)		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in 12-lead ECG (QRS interval)		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in 12-lead ECG (QT interval)		baseline (day 1), follow-up visit (day 8)
Secondary	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)
Secondary	Change from baseline in Physical examination		baseline (day 1), follow-up visit (day 8)
Secondary	Incidence of injection site reactions		After administration of the trial products (day 1) until completion of the post-treatment follow-up visit (day 8).
Secondary	AUC0-15min,SD, area under the plasma concentration time curve		0 to 15 minutes after single dose
Secondary	t1/2,SD, terminal half-life		Measured for 24 hours after administration of a single s.c. dose
Secondary	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
Secondary	AUCPG,0-15min,SD, area under the plasma glucose time curve		0 to 15 minutes after single dose
Secondary	?PG0-15min,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
Secondary	Change from baseline in 12-lead ECG (overall evaluation)		baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in prothrombin time	measured in seconds	baseline (day 1), follow-up visit (day 8)
Secondary	Change from baseline in Activated Partial Thromboplastin time (APTT)	measured in seconds	baseline (day 1), follow-up visit (day 8)