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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1244-4495 | Other Identifier | World Health Organization (WHO) | |
| 2019-004660-21 | Registry Identifier | European Medicines Agency (EudraCT) |
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This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions.
Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh.
The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak.
Women cannot take part if pregnant, breast- feeding or plan to become pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin icodec treatment sequence with injection region abdomen | Experimental | Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits. |
|
| Insulin icodec treatment sequence with injection region upper arm | Experimental | Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits. |
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| Insulin icodec treatment sequence with injection region thigh | Experimental | Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCIco,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 infinity 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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Mainz | 55116 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36631720 | Result | Plum-Morschel L, Andersen LR, Hansen S, Hovelmann U, Krawietz P, Kristensen NR, Lehrskov LL, Haahr H. Pharmacokinetic and Pharmacodynamic Characteristics of Insulin Icodec After Subcutaneous Administration in the Thigh, Abdomen or Upper Arm in Individuals with Type 2 Diabetes Mellitus. Clin Drug Investig. 2023 Feb;43(2):119-127. doi: 10.1007/s40261-022-01243-6. Epub 2023 Jan 11. |
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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 infinity after trial product administration (hours) |
| Day 1 |
| D004700 | Endocrine System Diseases |