Status and phase
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Study type
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Identifiers
About
This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes.
IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide.
Insulin icodec is a possible new medicine. That means that the medicine has not yet been approved by the authorities. Semaglutide is a medicine already approved by the authorities in the EU, USA, China and Japan.
The study will look at the way insulin icodec and semaglutide reach and stay in participants blood after injection when given together as IcoSema or alone as insulin icodec and semaglutide.
Participants will get each of the 3 medicines (IcoSema, insulin icodec and semaglutide) at 3 different timepoints:
The order in which participants get them is decided by chance. Participants will get the 3 medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks.
The study will last for about 19 to 26 weeks. Participants will have 31 or 32 visits to the clinic. 3 of the visits will be in-house visits, meaning that participants will stay at the clinic for 5 or 6 days (4 or 5 nights).
Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Chinese male or female
Aged 18-64 years (both inclusive) at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
Body mass index between 18.5 and 34.9 kg/m^2 (both inclusive)
Body weight greater than or equal to 50 kg
HbA1c (glycated haemoglobin) below or equal to 9.0% (75 mmol/mol)
Insulin naïve. However, short-term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
Stable daily dose(s) including any of the following anti-diabetic drug(s)/regimen within 45 days prior to the day of screening:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 6 patient groups
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Central trial contact
Novo Nordisk
Data sourced from clinicaltrials.gov
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