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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1121-5106 | Other Identifier | WHO |
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This trial is conducted in the United States of America (USA). The aim of the trial is to evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation 1 | Experimental |
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| Formulation 2 | Experimental |
| |
| Insulin aspart (NovoLog®) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faster-acting insulin aspart | Drug | Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in plasma glucose concentration | From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Self-measured plasma glucose (SMPG) 7-point profile | After the first, the second, and the third 14-day treatment period | |
| Self-measured plasma glucose (SMPG) 9-point profile | After the first, the second, and the third 14-day treatment period |
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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 | Atlanta | Georgia | 30318 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28055230 | Result | Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Faster-acting insulin aspart | Drug | Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period. |
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| insulin aspart | Drug | Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period. |
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| Number of adverse events (AEs) (including infusion site reactions/infections) | Days 0-14 for each treatment periods |
| Number of hypoglycaemic episodes | Days 0-14 for each treatment period |
| Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG) | Days 0-14 for each treatment period |
| Number of episodes of infusion set occlusions | Days 0-14 for each treatment period |
| 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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