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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001180-22 | EudraCT Number | ||
| U1111-1140-5344 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin 287 + placebo | Experimental | Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels). |
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| Insulin degludec + placebo | Active Comparator | Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | Administered once-weekly subcutaneously (s.c., under the skin) for 35 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | From the first trial product administration at Day 1 until completion of the post-treatment follow-up visit (3-14 days after Visit 9, Day 65) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the steady-state serum insulin 287 concentration-time curve | During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29) | |
| area under the glucose infusion rate - time curve at steady-state | At Day 31 and day 35 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin degludec | Drug | Administered once-daily subcutaneously (s.c., under the skin) for 35 days |
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| placebo | Drug | Administered subcutaneously (s.c., under the skin) once-daily for 35 days |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| 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 |
| C571886 | insulin degludec |
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