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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1271-9231 | Other Identifier | World Health Organization (WHO) |
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Insulin icodec is a new medicine which is under development for use in humans and is not yet available at the pharmacy. It is being developed for the treatment of diabetes, a condition that causes high blood sugar levels. Insulin icodec will be investigated in participants with type 2 diabetes. Participant will get one dose of insulin icodec, which will be administered in the afternoon or evening of the day of dosing. The study will last for about 8 weeks. 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 milliliter (mL) (a little less than a quarter of a teaspoonful). The amount of insulin icodec participant will receive depends on participant's body weight. Participant must not participate if participant meets certain conditions called exclusion criteria, such as an age of above 18 years when the informed consent is signed or has serious health conditions. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Type 2 Diabetes | Experimental | Participants will receive single subcutaneous (s.c.) fixed dose of insulin icodec (700 units per milliliter [U/mL]) that is 5.6 units per kilogram (U/kg) bodyweight. Subjects will be followed up for 5 weeks after dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | Participants will receive subcutaneously fixed dose of insulin icodec (700 U/mL) that is 5.6 U/kg bodyweight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD) | Measured in picomoles*hours per liter (pmol*h/L). | From 0 hours until infinity after trial product administration (day 1) |
| Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD) | Measured in picomoles per liter (pmol/L). | From 0 hours until last measurement time after trial product administration (day 1) |
| Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD) | Measured in hours. | From 0 hours until last measurement time after trial product administration (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model) | Measured in pmol/L. | From 0 to 168 hours after trial product administration |
| Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,Ï„,SS,model) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hosp-Los Angeles | Los Angeles | California | 90027 | United States | ||
| Children's Hospital Los Angeles - Endocrinology |
According to the Novo Nordisk disclosure commitment on NovoNordisk-trials.com
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Measured in pmol*h/L. |
| From 0 to 168 hours after trial product administration |
| Los Angeles |
| California |
| 90027 |
| United States |
| Yale New Haven Hospital, Hospital Research Unit | New Haven | Connecticut | 06510 | United States |
| Yale University | New Haven | Connecticut | 06511 | United States |
| Nemours Children's Health | Jacksonville | Florida | 32207 | United States |
| Nemours Chld Clnc Jacksonville | Jacksonville | Florida | 32207 | United States |
| Childrens Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| University Of Iowa_Iowa City | Iowa City | Iowa | 52242 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Pennington Biom Res Ctr | Baton Rouge | Louisiana | 70808 | United States |
| John Hopkins Univ Hosp | Baltimore | Maryland | 21287 | United States |
| UBMD Pediatrics | Buffalo | New York | 14203 | United States |
| UBMD Peds-Div of Endo/Diabetes | Buffalo | New York | 14203 | United States |
| Cincinnati Child's Hsp Med Ctr | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Children's Hosp Of Phil | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh Of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Texas Tech University HSC | Amarillo | Texas | 79106 | United States |
| NE Clin Res of San Antonio | Schertz | Texas | 78154 | United States |
| University of Virginia Clinical Research Unit | Charlottesville | Virginia | 22908 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000712207 | insulin icodec |
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