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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1199-1934 | Other Identifier | World Health Organization (WHO) |
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This study looks at how faster aspart reaches and stays in the blood after injection in Chinese people with type 1 diabetes or type 2 diabetes, compared to the reference product called NovoRapid®. Participants will get both faster aspart and NovoRapid®. The order in which Participants get them is decided by chance. Participants will get each study medicine once during the study meaning that they will get a total of 2 injections with study medicines. The medicine will be injected under the skin of the lower abdomen. The study will last for about 19-72 days. Participants will have 5 clinic visits with the study doctor (including the one in which participants give their consent). Participants will need to stay overnight for 2 of the 5 clinic visits. Participants will have blood samples taken during some of the clinic visits. During the visits where participants get the study medicines, samples of their blood will be taken several times for up to 12 hours after getting the study medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Faster aspart | Experimental | Subjects will receive 2 injections of a single dose of faster aspart at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes. |
|
| NovoRapid® | Active Comparator | Subjects will receive 2 injections of a single dose of NovoRapid® at a predefined fixed dose level (0.2 U/kg body weight) for type 1 diabetes and (0.3 U/kg body weight) if subject has type 2 diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faster Aspart | Drug | Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes | pmol·h/L | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| Measure | Description | Time Frame |
|---|---|---|
| AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve from 0 to 15 minutes | pmol·h/L | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| AUCIAsp,0-1h, area under the serum insulin aspart concentration-time curve from 0 to 1 hour |
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Inclusion criteria:
For a subject with type 1 diabetes mellitus:
For a subject with type 2 diabetes mellitus:
Exclusion criteria:
For a subject with type 1 diabetes mellitus or type 2 diabetes mellitus:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany | |||
| Phase 1 Clinical Trial Centre |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Novo Rapid | Drug | Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector. |
|
pmol·h/L |
| 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| AUCIAsp,0-1½h, area under the serum insulin aspart concentration-time curve from 0 to 1½ hours | pmol·h/L | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| AUCIAsp,0-2h, area under the serum insulin aspart concentration-time curve from 0 to 2 hours | pmol·h/L | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| AUCIAsp,0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours | pmol·h/L | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| Cmax,IAsp, maximum observed serum insulin aspart concentration | pmol/L | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| tmax,IAsp, time to maximum observed serum insulin aspart concentration | Minutes | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| Onset of appearanceIAsp, time from trial product administration until the first time serum insulin aspart concentration greater than or equal to lower limit of quantification (LLOQ) | Minutes | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| Time to 50 percent Cmax, IAsp, the first time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp | Minutes | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| Time to late 50 percent Cmax,IAsp, the last time point where the insulin aspart concentration equals 50 percent of Cmax,IAsp | Minutes | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| t½, terminal half-life for insulin aspart | Minutes | 0 to 12 hours after dosing on Day 2 of Visit 2 (3-21 days after screening) and Visit 3 (7-28 days after visit 2, day 2) |
| Number of treatment emergent adverse events | Count of Events | Until 7 days after IMP (investigational medicinal product) administration |
| Number of treatment emergent hypoglycaemic episodes | Count of Episodes | No longer than 16 hours after IMP administration until next administration of insulin (non-investigational medicinal product (NIMP) or subject's pre-trial insulin) |
| Shatin, New Territories, Hong Kong |
| Postal Code: NA |
| Hong Kong |
| Phase 1 Clinical Trial Centre | Shatin, New Territories | Hong Kong |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |