Status:
COMPLETED
A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. This study will look at the way insulin 287 and semaglutide reach and stay in participants' ...
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 more than or equal to 180 days prior to the day of screening
- Body weight between 80.0 to 120.0 kg (both inclusive)
- Glycosylated haemoglobin (HbA1c) 6.0 to 8.5% (both inclusive)
- No current and no regular previous intake of insulin. Previous insulin treatment for short periods of time (a maximum of 14 days) is allowed, as well as insulin use during a previous period of gestational diabetes in the past (as declared by the subject or reported in the medical records)
- Stable daily dose(s) of the following anti-diabetic drug(s)/regimen within the past 90 days prior to the day of screening: a) Any metformin formulation (dose as documented in the subject medical record), b) One other oral antidiabetic drug (dose as documented in the subject medical record) is allowed, but not mandatory: Insulin secretagogue (sulphonylureas), dipeptidyl peptidase 4 (DPP-4) inhibitor and sodium glucose co-transporter 2 (SGLT2) inhibitor
Exclusion
- Known or suspected hypersensitivity to trial products or related products
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening
- Receipt of any investigational medicinal product within 90 days before screening
- History of severe allergies to drugs or foods or a history of severe anaphylactic reaction
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03789578
Start Date
January 17 2019
End Date
October 10 2019
Last Update
November 12 2024
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460