Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is looking at the way insulin icodec stays and moves over time in the blood after injections in Chinese people with type 2 diabetes. Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin of the thigh. There will also be a run-in period that will last between 1 week and 8 weeks with daily doses of insulin degludec before start on insulin icodec. The study will last for about 15 to 22 weeks. Participants will have about 17 visits with the study doctor including phone contact during your run-in period. Participants will have blood samples taken at the clinic visits. Several samples of participants blood will be taken for up to 48 hours after getting the first and the last dose of insulin icodec. Participants must be a Chinese person diagnosed with type 2 diabetes for at least 6 months and be on basal insulin treatment for at least 2 months before participating in the study. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period
Interventions
DRUGinsulin icodec
Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin. The study will last for 15 to 22 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Chinese male or female * Aged 18-64 years (both inclusive) at the time of signing informed consent * Body mass index between 18 and 38 kg/m\^2 (both inclusive) * HbA1c (glycated haemoglobin) below or equal to 9% at screening * Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day greater than or equal to 60 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 60 days prior to the day of screening: * Any metformin formulation * Other oral antidiabetic drugs: DPP-4 (Dipeptidyl-peptidase-4) Inhibitors , SGLT2 (Sodium-glucose co-transporter-2) inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs) * Oral or injectable GLP-1 (Glucagon Like Peptide 1) Receptor Agonists
Exclusion criteria
* Known or suspected hypersensitivity to trial product(s) or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and run-in. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state | From 0 to 168 hours after trial product administration (Day 36) | pmol\*h/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose | From 0 to 168 hours after trial product administration (Day 36) | (pmol\*h/L)/(U/kg) |
| Maximum observed serum insulin icodec concentration after the last dose | From 0 to 168 hours after trial product administration (Day 36) | pmol/L |
| Maximum observed serum insulin icodec concentration after the last dose divided by dose | From 0 to 168 hours after trial product administration (Day 36) | (pmol/L)/(U/kg) |
| Time to maximum observed serum insulin icodec concentration after the last dose | From 0 to 168 hours after trial product administration (Day 36) | hours |
| Terminal half-life for insulin icodec at steady state | Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (Day 36) | hours |
Countries
China
Outcome results
None listed