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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1204-8233 | Other Identifier | World Health Organization (WHO) | |
| 2017-004538-27 | Registry Identifier | European Medicines Agency (EudraCT) |
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The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. This study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together. Participants will get 3 study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287, 2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is decided by chance. Participants will get all 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 32 weeks in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide plus insulin 287 | Experimental | Participants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)). |
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| Semaglutide alone | Experimental | Participants will get a single dose of semaglutide (treatment B) alone. |
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| Insulin 287 alone | Experimental | Participants will get a single dose of insulin 287 (NNC0148-0287 (treatment A)) alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0148-0287sema | Drug | Study staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose | Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287. | 0-840 hours |
| AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose | Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide. | 0-840 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose | Measured in pmol*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287. | 0-840 hours |
| Cmax, I287, maximum observed serum insulin 287 concentration after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39488821 | Result | Westergaard L, Alifrangis L, Buckley ST, Coester HV, Klitgaard T, Kristensen NR, Nishimura E, Norgreen L, Rocha TMP, Steensgaard DB, Vegge A, Plum-Morschel L. Pharmacokinetic Properties of a Once-Weekly Fixed-Ratio Combination of Insulin Icodec and Semaglutide Compared with Separate Administration of Each Component in Individuals with Type 2 Diabetes Mellitus. Clin Drug Investig. 2024 Nov;44(11):849-861. doi: 10.1007/s40261-024-01405-8. Epub 2024 Nov 3. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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This is a three-period cross-over trial. The treatments to be used are: Treatment A: insulin 287, Treatment B: semaglutide, and Treatment C: NNC0148-0287sema. The subjects will be randomised to one of the six treatment sequences in the trial: 1) ABC, 2) ACB, 3) BAC, 4) BCA, 5) CAB, and 6) CBA. The trial includes a screening visit followed by three 5 -week periods with pharmacokinetic sampling after single dose administration. The dose periods are separated by a 1-4 week washout period (from last pharmacokinetic sampling to next dosing). The follow-up period is 1-4 weeks after last pharmacokinetic sampling in period 3 (i.e. 6 to 9 weeks after last trial product administration). The total trial duration for the individual subjects participating in the trial will be 19 to 32 weeks (including follow-up), depending on individual visit schedules.
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Semaglutide | Drug | Study staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen. |
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| NNC0148-0287 | Drug | Study staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen. |
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Measured in pmol/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287. |
| 0-840 hours |
| tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose | Measured in hour (h) for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287. | 0-840 hours |
| AUCSema,0-∞, area under the plasma semaglutide concentration-time curve from 0 hours to infinity after a single dose | Measured in pmol*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide. | 0-840 hours |
| Cmax,Sema, maximum observed plasma semaglutide concentration after a single dose | Measured in pmol/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide. | 0-840 hours |
| tmax,Sema, time to maximum observed plasma semaglutide concentration after a single dose | Measured in hour (h) for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide. | 0-840 hours |
| Number of treatment emergent adverse events | Count of events. | Day 1 (beginning of each period) to day 36 (end of each period) |
| Number of hypoglycaemic episodes | Count of episodes. | Day 1 (beginning of each period) to day 36 (end of each period) |
| Antibodies for insulin 287: Change in anti-insulin 287 binding antibody levels | Measured as percentage B/T following administration of NNC0148 -0287sema and insulin 287. | Day -1 (pre-dose), Day 36 (end of period) |
| Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies | Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287. | Day 36 (end of period) |
| Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin | Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287. | Day 36 (end of period) |
| Antibodies for semaglutide: Change in anti-semaglutide binding antibody levels | Measured as percentage B/T following administration of NNC0148 -0287sema | Day -1 (pre-dose), Day 36 (end of period) |
| Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies | Percentage of events (yes/no) following administration of NNC0148 -0287sema. | Day 36 (end of period) |
| Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous glucagon-like peptide-1 (GLP-1) | Percentage of events (yes/no) following administration of NNC0148 -0287sema. | Day 36 (end of period) |
| Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-semaglutide binding antibody levels | Measured as percentage B/T. | Day 151 (follow-up/end-of-trial visit) |
| Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous GLP-1 | Percentage of events (yes/no). | Day 151 (follow-up/end-of-trial visit) |
| Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-insulin 287 binding antibody levels | Measured as percentage B/T. | Day 151 (follow-up/end-of-trial visit) |
| Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin | Percentage of events (yes/no). | Day 151 (follow-up/end-of-trial visit) |
| Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies | Percentage of events (yes/no). | Day 151 (follow-up/end-of-trial visit) |
| Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies cross reacting with endogenous GLP-1 | Percentage of events (yes/no). | Day 151 (follow-up/end-of-trial visit) |
| 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 |
|---|---|
| C000591245 | semaglutide |
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