Status:
COMPLETED
A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
20-64 years
Phase:
PHASE1
Brief Summary
This study will look at how insulin 287 works, if it is safe and the side effects in people who are Japanese with type 1 diabetes. The study will test how insulin goes through your blood, how long it ...
Eligibility Criteria
Inclusion
- Male or female, Japanese subjects, aged 20 - 64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening.
- Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day.
- Body mass index between 18.5 and 28.0 kg/m\^2 (both inclusive).
- HbA1c less than or equal to 9.0%.
Exclusion
- History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions (except conditions associated with diabetes mellitus).
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
- Known or suspected hypersensitivity to trial products or related products
Key Trial Info
Start Date :
December 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03766854
Start Date
December 7 2018
End Date
December 9 2019
Last Update
March 8 2021
Active Locations (1)
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1
Novo Nordisk Investigational Site
Fukuoka, Japan, 812-0025