Status:
COMPLETED
First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03444467
Start Date
February 5 2018
End Date
May 24 2018
Last Update
September 5 2018
Active Locations (1)
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1
Novo Nordisk Investigational Site
Berlin, Germany, 10117