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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1262-1959 | Other Identifier | World Health Organization (WHO) |
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This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes.
IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide.
Insulin icodec is a possible new medicine. That means that the medicine has not yet been approved by the authorities. Semaglutide is a medicine already approved by the authorities in the EU, USA, China and Japan.
The study will look at the way insulin icodec and semaglutide reach and stay in participants blood after injection when given together as IcoSema or alone as insulin icodec and semaglutide.
Participants will get each of the 3 medicines (IcoSema, insulin icodec and semaglutide) at 3 different timepoints:
The order in which participants get them is decided by chance. Participants will get the 3 medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks.
The study will last for about 19 to 26 weeks. Participants will have 31 or 32 visits to the clinic. 3 of the visits will be in-house visits, meaning that participants will stay at the clinic for 5 or 6 days (4 or 5 nights).
Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | All participants will get each of the 3 medicines at 3 different timepoints IcoSema - insulin icodec - semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
|
| Sequence 2 | Experimental | All participants will get each of the 3 medicines at 3 different timepoints IcoSema- semaglutide . insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
|
| Sequence 3 | Experimental | All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- IcoSema- semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
|
| Sequence 4 | Experimental | All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- semaglutide - IcoSema separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
|
| Sequence 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IcoSema | Drug | One single dose of IcoSema administered subcutaneously, S.c. into the left thigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose | Measured in hours*pmol/L | From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration |
| Dose-normalised AUCSema,0-tz: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose | Measured in (hours*nmol/L)/mg | From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration |
| Measure | Description | Time Frame |
|---|---|---|
| AUCIco,0-inf: Area under the serum insulin icodec concentration-time curve after a single dose | Measured in hours*pmol/L | From 0 hours to infinity after IMP administration (day 1) |
| Cmax,Ico: Maximum observed serum insulin icodec concentration after a single dose |
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Inclusion Criteria:
Chinese male or female
Aged 18-64 years (both inclusive) at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
Body mass index between 18.5 and 34.9 kg/m^2 (both inclusive)
Body weight greater than or equal to 50 kg
HbA1c (glycated haemoglobin) below or equal to 9.0% (75 mmol/mol)
Insulin naïve. However, short-term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
Stable daily dose(s) including any of the following anti-diabetic drug(s)/regimen within 45 days prior to the day of screening:
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 |
|---|---|---|---|---|---|---|
| Peking University Third Hospital, Northern branch-Phase I | Beijing | Beijing Municipality | 100089 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41051695 | Derived | Wang F, Luan Z, Maltesen R, Reenberg AT, Westergaard L, Liu D. Pharmacokinetic Characteristics of a Once-Weekly Combination Therapy of Insulin Icodec and Semaglutide Versus Its Separate Components in Chinese Individuals with Type 2 Diabetes. Diabetes Ther. 2025 Nov;16(11):2213-2225. doi: 10.1007/s13300-025-01803-x. Epub 2025 Oct 6. |
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"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Sponsor staff involved in the clinical trial is masked according to company standard procedures
| Experimental |
All participants will get each of the 3 medicines at 3 different timepoints semaglutide - IcoSema - insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
|
| Sequence 6 | Experimental | All participants will get each of the 3 medicines at 3 different timepoints semaglutide - insulin icodec - IcoSema, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks. |
|
| insulin icodec | Drug | One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh |
|
| semaglutide | Drug | One single dose of semaglutide administered subcutaneously, S.c. into the left thigh |
|
Measured in pmol/L |
| From 0 hours until last measurement time after IMP administration (day 1) |
| tmax,Ico: Time to maximum observed serum insulin icodec concentration after a single dose | Measured in hours | From 0 hours until last measurement time after IMP administration (day 1) |
| t1/2,Ico: Terminal half-life for insulin icodec after a single dose | Measured in 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 IMP administration (day 1) |
| Dose-normalised AUCSema,0-inf: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose | Measured in (hours*nmol/L)/mg | From 0 hours to infinity after IMP administration (day 1) |
| Dose-normalised Cmax,Sema: Maximum observed plasma semaglutide concentration after a single dose divided by dose | Measured in (nmol/L)/mg | From 0 hours until last measurement time after IMP administration (day 1) |
| tmax,Sema: Time to maximum observed plasma semaglutide concentration after a single dose | Measured in hours | From 0 hours until last measurement time after IMP administration (day 1) |
| t1/2,Sema: Terminal half-life for semaglutide after a single dose | Measured in hours | Terminal part of the plasma semaglutide concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1) |
| Adverse events | Number of events | From IMP administration (day 1) to end of follow-up for each treatment period (day 36) |
| 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 |
| C000591245 | semaglutide |
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