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Completed

NCT Number: NCT03444467

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC9204-1513

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.

glucagon

Drug

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

Other names: GlucaGen®

Placebo

Drug

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

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: from time of dosing (day 1) to completion of the safety follow-up visit (day 8)

    Count of events

Secondary outcomes

  1. Change from baseline in haematology

    Time frame: baseline (day 1), follow-up visit (day 8)

  2. Change from baseline in biochemistry

    Time frame: baseline (day 1), follow-up visit (day 8)

  3. Change from baseline in fibrinogen

    Time frame: baseline (day 1), follow-up visit (day 8)

    measured in g/L

  4. Change from baseline in lipids

    Time frame: baseline (day 1), follow-up visit (day 8)

  5. Change from baseline in glucose metabolism

    Time frame: baseline (day 1), follow-up visit (day 8)

  6. Change from baseline in hormones

    Time frame: baseline (day 1), follow-up visit (day 8)

  7. Change from baseline in urine dipstick parameter

    Time frame: baseline (day 1), follow-up visit (day 8)

  8. Change from baseline in systolic- and diastolic blood pressure

    Time frame: baseline (day 1), follow-up visit (day 8)

    Measured in mm Hg

  9. Change from baseline in body temperature

    Time frame: baseline (day 1), follow-up visit (day 8)

  10. Change from baseline in respiration rate

    Time frame: baseline (day 1), follow-up visit (day 8)

  11. Change from baseline in 12-lead electrocardiogram (ECG) heart rate

    Time frame: baseline (day 1), follow-up visit (day 8)

  12. Change from baseline in 12-lead ECG (RR interval)

    Time frame: baseline (day 1), follow-up visit (day 8)

  13. Change from baseline in 12-lead ECG (PR interval)

    Time frame: baseline (day 1), follow-up visit (day 8)

  14. Change from baseline in 12-lead ECG (QRS interval)

    Time frame: baseline (day 1), follow-up visit (day 8)

  15. Change from baseline in 12-lead ECG (QT interval)

    Time frame: baseline (day 1), follow-up visit (day 8)

  16. Change from baseline in 12-lead ECG (QTc intervals [Fridericia])

    Time frame: baseline (day 1), follow-up visit (day 8)

    QT interval corrected for heart rate by Fridericia's formula

  17. Change from baseline in Physical examination

    Time frame: baseline (day 1), follow-up visit (day 8)

  18. Incidence of injection site reactions

    Time frame: After administration of the trial products (day 1) until completion of the post-treatment follow-up visit (day 8).

  19. AUC0-15min,SD, area under the plasma concentration time curve

    Time frame: 0 to 15 minutes after single dose

  20. t1/2,SD, terminal half-life

    Time frame: Measured for 24 hours after administration of a single s.c. dose

  21. Onset of appearance

    Time frame: 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)

  22. AUCPG,0-15min,SD, area under the plasma glucose time curve

    Time frame: 0 to 15 minutes after single dose

  23. ΔPG0-15min,SD, Increase in plasma glucose concentration from 0 to 15 minutes

    Time frame: 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

  24. Change from baseline in 12-lead ECG (overall evaluation)

    Time frame: baseline (day 1), follow-up visit (day 8)

  25. Change from baseline in prothrombin time

    Time frame: baseline (day 1), follow-up visit (day 8)

    measured in seconds

  26. Change from baseline in Activated Partial Thromboplastin time (APTT)

    Time frame: baseline (day 1), follow-up visit (day 8)

    measured in seconds

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2018
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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