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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444467
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: NNC9204-1513 Drug: Glucagon Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose: Treatment
Official Title: A Randomised, Double-blinded, Single Subcutaneous Dose Escalation Trial Investigating the Safety and Tolerability of NNC9204-1513 in Healthy Subjects
Actual Study Start Date : February 5, 2018
Actual Primary Completion Date : May 24, 2018
Actual Study Completion Date : May 24, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

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: Glucagon
Participants will receive single dose of 1 mg glucagon s.c. injection.
Other Name: GlucaGen®

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444467


Locations
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Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10117
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03444467    
Other Study ID Numbers: NN9513-4290
U1111-1180-8217 ( Other Identifier: World Health Organization (WHO) )
2016-001173-33 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://www.novonordisk-trials.com/

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs