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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005172-41 | EudraCT Number | ||
| U1111-1125-2924 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with type 1 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial part 1 | Experimental |
| |
| Trial part 2, treatment A | Experimental |
| |
| Trial part 2, treatment B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 148-0287-A-4.2mM-cartridge | Drug | In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AE) | From trial product administration until completion of the post-treatment follow-up visit at Day 37 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoglycaemic episodes | From trial product administration until completion of the post-treatment follow-up visit at Day 37 | |
| AUC, the area under the serum insulin 287 concentration-time curve | From dosing visit to infinity calculated from a 0-36 days NNC0148-0287 serum concentration-time-curve based on 43 sampling time points |
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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 |
|---|---|---|---|---|---|---|
| Neuss | 41460 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously. |
|
| 148-0287-A-4.2mM-cartridge | Drug | In a dose-escalating design, subjects with type 1 diabetes will receive a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B. |
|
| placebo | Drug | In a dose-escalating design, subjects with type 1 diabetes will receive 148-0287-A-placebo-cartridge in a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B. |
|
| insulin glargine | Drug | In a dose-escalating design, subjects with type 1 diabetes will receive insulin glargine once daily, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B. |
|
| sodium chloride 0.9% w/v | Drug | In a dose-escalating design, subjects with type 1 diabetes will receive sodium chloride 0.9% w/v, injected subcutaneously daily. Subjects will only be randomised to receive either treatment A or B. |
|
| Cmax, the maximum serum insulin 287 concentration | Observed (within 0-36 days) |
| tmax, the time for maximum serum insulin 287 concentration | Within 0-36 days |
| Average morning fasting blood glucose (FBG) concentration | From Day 2 to Day 8 |
| Average morning fasting serum C-peptide concentration | From Day 2 to Day 8 |
| Average morning fasting serum free fatty acid (FFA) concentration | From Day 2 to Day 8 |
| Area under the glucose infusion rate (GIR)-time curve | At Day 1-2, 4-5, or 7-8 |
| The maximal GIR (glucose infusion rate) observed | At Day 1-2, 4-5, or 7-8 |
| 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 |
| D012965 | Sodium Chloride |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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