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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1209-2099 | Other Identifier | World Health Organization (WHO) | |
| 2018-000593-30 | Registry Identifier | European Medicines Agency (EudraCT) |
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This study is looking at how five different formulations of faster aspart 200 U/mL reach and stay in the blood after injection. The purpose is to find a formulation that behaves similarly to the reference product called faster aspart 100 U/mL (marketed as Fiasp®). The participant will get all five formulations and the reference product. The order in which the participant gets them is decided by chance. The participant will get each medicine once during the study meaning that the participant will get a total of six injections with study medicine. The medicine will be injected under the skin in the stomach. The study will last for about 2 to 21 weeks depending on individual visit schedule. The participant will have nine clinic visits with the study doctor (including the one in which the participant give consent).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation D, faster aspart 100 U/mL, formulation B, formulation A, formulation C, formulation E. The dosing visits will be separated by wash-out periods (2-21 days). |
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| Group B | Experimental | Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation C, formulation B, formulation D, formulation E, formulation A, faster aspart 100 U/mL. The dosing visits will be separated by wash-out periods (2-21 days). |
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| Group C | Experimental | Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation E, formulation C, formulation A, formulation B, faster aspart 100 U/mL, formulation D. The dosing visits will be separated by wash-out periods (2-21 days). |
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| Group D | Experimental | Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation A, formulation D, formulation C, faster aspart 100 U/mL, formulation E, formulation B. The dosing visits will be separated by wash-out periods (2-21 days). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faster Aspart 200 U/mL | Drug | A single dose (0.15 U/kg) of five formulations of fast-acting insulin aspart 200 U/mL (formulations A, B, C, D, E) in a sequential manner via subcutaneous injection. |
| Measure | Description | Time Frame |
|---|---|---|
| AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure | Measured in pmol*h/L | 0 to 10 hours after IMP administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration | Measured in pmol*h/L | 0 to 1 hour after IMP administration |
| AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration |
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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 |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Neuss | 41460 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is asked according to company standard procedures
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| Group E | Experimental | Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: faster aspart 100 U/mL, formulation A, formulation E, formulation D, formulation B, formulation C. The dosing visits will be separated by wash-out periods (2-21 days). |
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| Group F | Experimental | Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation B, formulation E, faster aspart 100 U/mL, formulation C, formulation D, formulation A. The dosing visits will be separated by wash-out periods (2-21 days). |
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| Faster aspart 100 U/mL | Drug | A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection. |
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Measured in pmol*h/L |
| 0 to 2 hours after IMP administration |
| AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity | Measured in pmol*h/L | 0 to 10 hours after IMP administration |
| Cmax,IAsp - Maximum observed serum insulin aspart concentration | Measured in pmol/L | 0 to 10 hours after IMP administration |
| tmax,IAsp - Time to maximum observed serum insulin aspart concentration | Measured in minutes | 0 to 10 hours after IMP administration |
| Number of adverse events in the treatment emergent period | Count of events | 0 to 2 days after IMP administration |
| Number of local reactions at the injection site in the treatment emergent period | Count of injection site reactions | 0 to 2 days after IMP administration |
| Number of hypoglycaemic episodes in the treatment emergent period | Count of hypoglycaemic episodes | 0 to 16 hours after IMP administration |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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