Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1244-4473 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin icodec | Experimental | The participants will receive an individualised weekly dose of subcutaneously (s.c.) insulin icodec for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin icodec | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state | pmol*h/L | From 0 to 168 hours after trial product administration (Day 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose | (pmol*h/L)/(U/kg) | From 0 to 168 hours after trial product administration (Day 36) |
| Maximum observed serum insulin icodec concentration after the last dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (Dept.1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100853 | China |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712207 | insulin icodec |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
pmol/L |
| From 0 to 168 hours after trial product administration (Day 36) |
| Maximum observed serum insulin icodec concentration after the last dose divided by dose | (pmol/L)/(U/kg) | From 0 to 168 hours after trial product administration (Day 36) |
| Time to maximum observed serum insulin icodec concentration after the last dose | hours | From 0 to 168 hours after trial product administration (Day 36) |
| Terminal half-life for insulin icodec at steady state | hours | 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) |
| D004700 | Endocrine System Diseases |