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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000200-28 | EudraCT Number | ||
| U1111-1178-3964 | Other Identifier | WHO |
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A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects with Type 2 Diabetes Mellitus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Faster Aspart | Experimental |
| |
| Insulin Aspart | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faster-acting insulin aspart | Drug | A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum insulin aspart concentration-time curve | From 0 to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum insulin aspart concentration | Within 0 to 12 hours after dosing | |
| Area under the glucose infusion rate curve | From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing) |
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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 | Graz | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31069935 | Result | Pieber TR, Svehlikova E, Brunner M, Halberg IB, Due Thomsen KM, Haahr H. Fast-acting insulin aspart in people with type 2 diabetes: Earlier onset and greater initial exposure and glucose-lowering effect compared with insulin aspart. Diabetes Obes Metab. 2019 Sep;21(9):2068-2075. doi: 10.1111/dom.13767. Epub 2019 Jun 10. |
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| Insulin Aspart | Drug | A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight. |
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| Maximum glucose infusion rate | Within 0 to 12 hours after dosing |
| 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 |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-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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