Status:
COMPLETED
A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-24 years
Phase:
PHASE1
Brief Summary
This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump. The study will...
Eligibility Criteria
Inclusion
- Male participant or female participant of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with T1DM for more than1 year prior to the day of screening.
- Current total daily insulin treatment between 0.2 and 1.2 (I)U/kg/day (both inclusive).
- Treated with continuous subcutaneous insulin infusion greater than 90 days prior to the day of screening.
Exclusion
- Known or suspected hypersensitivity to study interventions or related products.
- Participation (i.e., study intervention) in any interventional, clinical study within 30 days or 5 times the half-life of the drug, whichever is longest before screening.
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2022
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05262595
Start Date
March 3 2022
End Date
September 5 2022
Last Update
October 12 2023
Active Locations (1)
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1
Novo Nordisk Investigational Site
Graz, Austria, 8010