Status:
COMPLETED
A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
This study looks at the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentration in the blood and its effect on the blood sugar for the treatment of dia...
Eligibility Criteria
Inclusion
- Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus 180 days or more prior to the day of screening.
- Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
- Current total daily insulin treatment between 0.25 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
- HbA1c equal to or below 9.5%
Exclusion
- Male of reproductive age who, or whose partner(s), is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
- Use of GLP-1 receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 3 months prior to screening.
Key Trial Info
Start Date :
October 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04136067
Start Date
October 29 2019
End Date
August 23 2020
Last Update
September 8 2022
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neuss, Germany, 41460