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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000071-70 | EudraCT Number | ||
| U1111-1151-9327 | Other Identifier | WHO |
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This trial is conducted in Europe. The purpose is to evaluate safety and tolerability of a range of single doses of subcutaneous insulin 338.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 insulin 338 | Experimental |
| |
| Part 1 placebo | Placebo Comparator |
| |
| Part 2 insulin 338 | Experimental |
| |
| Part 2 insulin glargine | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin 338 | Drug | Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin). |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Day 1 - day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoglycaemic episodes | Day 1 - day 22 | |
| Area under the serum insulin 338 concentration-time curve from zero to infinity | Day 1- day 22 | |
| Maximum serum insulin 338 concentration observed |
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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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| placebo | Drug | Healthy subjects will receive a single dose of placebo. Injected subcutaneously (under the skin). |
|
| Insulin 338 | Drug | Subjects with type 1 DM will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin). |
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| insulin glargine | Drug | Subjects with type 1 DM will receive 0.4 U/kg insulin glargine once daily for 4 days. Injected subcutaneously (under the skin). |
|
| Day 1- day 22 |
| Time for maximum serum insulin 338 concentration | Day 1- day 22 |
| t1/2, the terminal half-life of insulin 338 | Day 1- day 22 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| 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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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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