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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-4162 | Other Identifier | World Health Organization (WHO) | |
| 2021-003271-33 | EudraCT Number |
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This study is designed to investigate the movement of insulin NNC0363-0845 throughout the body and how it works for the treatment of type 1 diabetes mellitus.
The aim of the study is to improve clinical outcomes for patients with type 1 diabetes mellitus by better controlling the blood sugar levels.
Participants will get insulin NNC0363-0845 as well as insulin detemir (Levemir®). NNC0363-0845 is a new insulin molecule designed to provide blood sugar-dependent insulin action, while insulin detemir is commonly used and prescribed by doctors.
Participants will get subcutaneous (under your skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days, and of insulin detemir up to 6 times daily for another 3 days. Which medication participants receive first and which second, insulin NNC0363-0845 or insulin detemir, is decided by chance.
The study will last for about 6 weeks up to a maximum of 14 weeks. Participants will have 2 in-house visits (where participants will stay at the site for 4 nights) and 5 outpatient visits with the study doctor. Participants will have frequent contact with the study doctor during the study.
During the in-house visits, two intravenous catheters (a thin tube inserted into a vein) will be inserted for blood sampling and infusions.
Interested parties may not participate in the study if the study doctor believes it will affect their health negatively.
Women cannot take part if they are of childbearing potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0363-0845 followed by insulin detemir | Experimental | Participants will get subcutaneous (under the skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of insulin detemir up to 6 times daily for 3 days. |
|
| Insulin detemir followed by NNC0363-0845 | Experimental | Participants will get subcutaneous (under the skin) injections of insulin detemir up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of NNC0363-0845 (study medicine) up to 6 times daily for 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0363-0845 | Drug | Participants will receive 0.5 nmol/kg NNC0363-0845 s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 3 nmol/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUCPG,0.5-2h Area under the plasma glucose-time curve at steady concentrations | messured in h*mmol/L | From 0.5 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3) |
| Measure | Description | Time Frame |
|---|---|---|
| AUCPG,0-1h Area under the plasma glucose-time curve at steady concentrations | messured in h*mmol/L | From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3) |
| AUCPG,0-2hArea under the plasma glucose-time curve at steady concentrations |
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Graz | 8010 | Austria |
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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| Insulin detemir | Drug | Participants will receive 0.083 U/kg insulin detemir s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 0.5 U/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks |
|
messured in h*mmol/L |
| From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3) |
| AUCPG,0-4h Area under the plasma glucose-time curve at steady concentrations | messured in h*mmol/L | From 0 to 4 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3) |
| ∆PGav,0-1h Mean change in plasma glucose at steady concentrations | messured in mmol/L | From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3) |
| ∆PGav,0-2h Mean change in plasma glucose at steady concentrations | messured in mmol/L | From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3) |
| Number of adverse events | Number of events | From first IMP administration until 16 hours after last IMP administration (visit 4 day 3 and visit 5 day 3) |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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 |
|---|---|
| D000069057 | Insulin Detemir |
| 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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