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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004144-35 | EudraCT Number | ||
| U1111-1162-2053 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the postprandial glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1 diabetes.
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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 | Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in plasma glucose concentration | From 0-1 hour after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of endogenous glucose production | From 0-6 hours after trial product administration | |
| Area under the serum insulin aspart concentration-time curve | From 0-6 hours after trial product administration |
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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 |
|---|---|---|---|
| 29493118 | Result | Basu A, Pieber TR, Hansen AK, Sach-Friedl S, Erichsen L, Basu R, Haahr H. Greater early postprandial suppression of endogenous glucose production and higher initial glucose disappearance is achieved with fast-acting insulin aspart compared with insulin aspart. Diabetes Obes Metab. 2018 Jul;20(7):1615-1622. doi: 10.1111/dom.13270. Epub 2018 Mar 30. | |
| 30402720 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| insulin aspart | Drug | Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed. |
|
| Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6. |
| 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 |
|---|---|
| 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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