DiabetesPhase 1NCT03444467
First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.
A Phase 1 study testing NNC9204-1513 and Glucagon in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- NNC9204-1513 and Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 5 Feb 2018to 24 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- NNC9204-1513, Glucagon, Placebo
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC9204-1513Drug
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.
GlucagonDrug
Also called GlucaGen®
Participants will receive single dose of 1 mg glucagon s.c. injection.
PlaceboDrug
Participants will receive single dose of placebo (for double dummy injections).
| Study group | Role | What they receive |
|---|---|---|
| NNC9204-1513 | Experimental | Participants will receive increasing doses of NNC9204-1513. Receives: Drug: NNC9204-1513; Drug: Placebo |
| Glucagon | Active comparator | Participants will receive a single fixed dose of glucagon. Receives: Drug: Glucagon; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Count of events
Measured: from time of dosing (day 1) to completion of the safety follow-up visit (day 8)
Secondary outcomes (26)
Change from baseline in haematology
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in biochemistry
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in fibrinogen
measured in g/L
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in lipids
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in glucose metabolism
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in hormones
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in urine dipstick parameter
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in systolic- and diastolic blood pressure
Measured in mm Hg
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in body temperature
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in respiration rate
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead electrocardiogram (ECG) heart rate
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (RR interval)
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (PR interval)
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (QRS interval)
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in 12-lead ECG (QT interval)
Measured: 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
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in Physical examination
Measured: baseline (day 1), follow-up visit (day 8)
Incidence of injection site reactions
Measured: 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
Measured: 0 to 15 minutes after single dose
t1/2,SD, terminal half-life
Measured: 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: Measured for 24 hours after administration of a single s.c. dose
AUCPG,0-15min,SD, area under the plasma glucose time curve
Measured: 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
Measured: 0 to 15 minutes after single dose
Change from baseline in 12-lead ECG (overall evaluation)
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in prothrombin time
measured in seconds
Measured: baseline (day 1), follow-up visit (day 8)
Change from baseline in Activated Partial Thromboplastin time (APTT)
measured in seconds
Measured: baseline (day 1), follow-up visit (day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start5 Feb 2018
- Primary completion24 May 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444467
- Sponsor's protocol ID
- NN9513-4290
- Other IDs
- U1111-1180-8217, 2016-001173-33, 2016
- Status last verified
- Sep 2018
- First submitted
- 5 Feb 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blinded, Single Subcutaneous Dose Escalation Trial Investigating the Safety and Tolerability of NNC9204-1513 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03444467
- Acronym / sponsor ID
- NN9513-4290
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC9204-1513 | Experimental | Drug: NNC9204-1513, Drug: PlaceboParticipants will receive increasing doses of NNC9204-1513. |
| Glucagon | Active comparator | Drug: Glucagon, Drug: PlaceboParticipants will receive a single fixed dose of glucagon. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC9204-1513Participants 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 | NNC9204-1513 |
| GlucagonAlso: GlucaGen®Participants will receive single dose of 1 mg glucagon s.c. injection. | Drug | Glucagon |
| PlaceboParticipants will receive single dose of placebo (for double dummy injections). | Drug | Glucagon, NNC9204-1513 |
Primary outcome
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
26 secondary outcomes
Change from baseline in haematology
Time frame: baseline (day 1), follow-up visit (day 8)
Change from baseline in biochemistry
Time frame: baseline (day 1), follow-up visit (day 8)
Change from baseline in fibrinogen
Time frame: baseline (day 1), follow-up visit (day 8)
Change from baseline in lipids
Time frame: baseline (day 1), follow-up visit (day 8)
Change from baseline in glucose metabolism
Time frame: baseline (day 1), follow-up visit (day 8)
Change from baseline in hormones
Time frame: 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)
Change from baseline in systolic- and diastolic blood pressure
Time frame: baseline (day 1), follow-up visit (day 8)
Change from baseline in body temperature
Time frame: baseline (day 1), follow-up visit (day 8)
Change from baseline in respiration rate
Time frame: 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)
Change from baseline in 12-lead ECG (RR interval)
Time frame: 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)
Change from baseline in 12-lead ECG (QRS interval)
Time frame: 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)
Change from baseline in 12-lead ECG (QTc intervals [Fridericia])
Time frame: baseline (day 1), follow-up visit (day 8)
Change from baseline in Physical examination
Time frame: 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).
AUC0-15min,SD, area under the plasma concentration time curve
Time frame: 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
Onset of appearance
Time frame: 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
ΔPG0-15min,SD, Increase in plasma glucose concentration from 0 to 15 minutes
Time frame: 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)
Change from baseline in prothrombin time
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC9204-1513 and Glucagon in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.