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Participants will receive one insulin icodec dose, which will be administered in the morning of the day of dosing.
The study will last for about 8 weeks. Participants will have 8 visits with the study doctor in the clinical research unit.
Insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 mL (about a spoonful).
Participants must not participate if they meet certain conditions called exclusion criteria, such as an age of below 18 years or above 70 years, if participants are over- or underweight, using certain medicines, or have serious health conditions (other than impaired liver function ).
Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with normal hepatic function | Experimental | The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. |
|
| Subjects with mild hepatic impairment, child-pugh grade A | Experimental | The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. |
|
| Subjects with moderate hepatic impairment, child-pugh grade B | Experimental | The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. |
|
| Subjects with severe hepatic impairment, child-pugh grade C | Experimental | The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | Insulin icodec will be investigated in participants with impaired liver function and subjects with normal liver function. Administered as a single dose subcutaneously (under the skin) The study will last for about 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose | From 0 hours until infinity after trial product administration (pmol*h/L) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose | From 0 hours until last measurement time after trial product administration (pmol/L) | Day 1 |
| tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates CZ, s.r.o. | Prague | 17000 | Czechia | |||
| Summit Clinical Research s.r.o. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38722461 | Result | Haahr H, Cieslarova B, Hingst JR, Jiang S, Kristensen NR, Kupcova V, Norgreen L, Wagner FH, Ignatenko S. The Effect of Various Degrees of Renal or Hepatic Impairment on the Pharmacokinetic Properties of Once-Weekly Insulin Icodec. Clin Pharmacokinet. 2024 Jun;63(6):819-830. doi: 10.1007/s40262-024-01375-2. Epub 2024 May 9. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000712207 | insulin icodec |
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From 0 hours until last measurement time after trial product administration (hours) |
| Day 1 |
| Bratislava |
| 83101 |
| Slovakia |
| D004700 | Endocrine System Diseases |