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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1244-4346 | Other Identifier | World Health Organization (WHO) | |
| 2019-004606-10 | Registry Identifier | European Medicines Agency (EudraCT) |
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The aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment.
Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors.
Participants will administer subcutaneous injections of insulin degludec once daily for at least one week (7 injections) but this period may be extended up to 8 weeks. Thereafter, once weekly subcutaneous injections of insulin icodec will follow, resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec.
The study will last for about 17-32 weeks Participants will have at least 5 in-house visits (where participants will stay at the clinic) and 17 outpatient visits with the study doctor.
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 | Experimental | Participants will receive individualised weekly doses of insulin icodec |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Icodec | Drug | Participants will receive 1 dose from a prefilled pen, administered subcutaneously (under the skin), once a week by designated study staff, for a total of at least 8 and a maximum of 16 doses which equals 8-16 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| AUCIco,τ,SS, 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 50) |
| Measure | Description | Time Frame |
|---|---|---|
| AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state | mg/kg | From 0 to 36 hours after trial product administration (Day 36) |
| AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state |
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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 | Graz | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37694740 | Background | Pieber TR, Asong M, Fluhr G, Holler V, Kristensen NR, Larsen JH, Ribel-Madsen R, Svehlikova E, Vinther S, Voortman M, Haahr H. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 2 diabetes. Diabetes Obes Metab. 2023 Dec;25(12):3716-3723. doi: 10.1111/dom.15266. Epub 2023 Sep 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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mg/kg
| From 40 to 64 hours after trial product administration (Day 43) |
| AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state | mg/kg | From 144 to 168 hours after trial product administration (Day 50) |
| AUCGIR,τ,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state | mg/kg | From 0 to 168 hours after trial product administration (Day 50) |
| AUCIco,τ,SS, 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 and 43) |
| Dose-normalised AUCIco,τ,SS, 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 50) |
| Cmax,Ico,SS, Maximum observed serum insulin icodec concentration during one dosing interval at steady state | pmol/L | From 0 to 168 hours after trial product administration (Day 36, 43 and 50) |
| Dose-normalised Cmax,Ico,SS, 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 50) |
| tmax,Ico,SS, Time to maximum observed serum insulin icodec concentration after the last dose | hours | From 0 to 168 hours after trial product administration (Day 50) |
| t½,Ico,SS, 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 50) |
| D004700 | Endocrine System Diseases |