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

September 3, 2018 updated by: Novo Nordisk A/S

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
from time of dosing (day 1) to completion of the safety follow-up visit (day 8)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in haematology
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in biochemistry
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in fibrinogen
Time Frame: baseline (day 1), follow-up visit (day 8)
measured in g/L
baseline (day 1), follow-up visit (day 8)
Change from baseline in lipids
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in glucose metabolism
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in hormones
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in urine dipstick parameter
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in systolic- and diastolic blood pressure
Time Frame: baseline (day 1), follow-up visit (day 8)
Measured in mm Hg
baseline (day 1), follow-up visit (day 8)
Change from baseline in body temperature
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in respiration rate
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead electrocardiogram (ECG) heart rate
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (RR interval)
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (PR interval)
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (QRS interval)
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (QT interval)
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
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
baseline (day 1), follow-up visit (day 8)
Change from baseline in Physical examination
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
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).
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
Time Frame: 0 to 15 minutes after single dose
0 to 15 minutes after single dose
t1/2,SD, terminal half-life
Time Frame: Measured for 24 hours after administration of a single s.c. dose
Measured for 24 hours after administration of a single s.c. dose
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)
Measured for 24 hours after administration of a single s.c. dose
AUCPG,0-15min,SD, area under the plasma glucose time curve
Time Frame: 0 to 15 minutes after single dose
0 to 15 minutes after single dose
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
0 to 15 minutes after single dose
Change from baseline in 12-lead ECG (overall evaluation)
Time Frame: baseline (day 1), follow-up visit (day 8)
baseline (day 1), follow-up visit (day 8)
Change from baseline in prothrombin time
Time Frame: baseline (day 1), follow-up visit (day 8)
measured in seconds
baseline (day 1), follow-up visit (day 8)
Change from baseline in Activated Partial Thromboplastin time (APTT)
Time Frame: baseline (day 1), follow-up visit (day 8)
measured in seconds
baseline (day 1), follow-up visit (day 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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