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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1260-0359 | Other Identifier | World Health Organization (WHO) | |
| 2020-005145-16 | EudraCT Number |
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This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump.
The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered.
The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®).
Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes.
Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance.
The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each.
During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions.
Women: Women cannot take part if they are of childbearing potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
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| Arm 2 | Experimental | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
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| Arm 3 | Experimental | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
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| Arm 4 | Active Comparator | A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0471-0119 A | Drug | NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC (NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected) | Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours). Measured in percentage | 0 to 12 hours after bolus infusion |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (NNC0471-0119,0-t,basal-corrected) | Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours). Measured in h*pmol/L | 0 to 12 hours after bolus infusion |
| AUC (NNC0471-0119,0-30min,basal-corrected) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | 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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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| NNC0471-0119 B | Drug | NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months |
|
| NNC0471-0119 D | Drug | NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months |
|
| Faster aspart | Drug | Faster aspart administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months |
|
Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes. Measured in h*pmol/L |
| 0 to 30 minutes after bolus infusion |
| AUC (NNC0471-0119,2h-t,basal-corrected) | Area under the basal-corrected serum NNC0471-0119 concentration time curve from 2 hours to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours). Measured in h*pmol/L | 2 to 12 hours after bolus infusion |
| AUC (NNC0471-0119,2h-t,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected) | Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 2 hours to t and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours). Measured in percentage | 0 to 12 hours after bolus infusion |
| Cmax,NNC0471-0119,basal-corrected: Maximum observed basal-corrected serum NNC0471-0119 concentration | pmol/L | 0 to 12 hours after bolus infusion |
| Number of adverse events (AEs) | Number of events | From start of first investigational medicinal product ( IMP) basal rate infusion (Visit 2, day -1) until completion of post-treatment end-of-study visit (Visit 6) |
| AUC (GIR,0-t,basal-corrected) | Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to t, where t is the first time the GIR curve is back to basal level after bolus infusion (at most 12 hours). Measured in mg/kg | 0 to 12 hours after bolus infusion |
| AUC (GIR,0-1h,basal-corrected) | Area under the basal-corrected GIR-time curve from 0 to 1 hour. Measured in mg/kg | 0 to 1 hour after bolus infusion |
| AUC (GIR,0-1h,basal-corrected/AUC (GIR,0-t,basal-corrected) | Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t, where t is the first time the GIR curve is back to basal level after bolus infusion (at most 12 hours). Measured in percentage | 0 to 12 hours after bolus infusion |
| GIRmax,basal-corrected: Maximum observed basal-corrected GIR | mg/(kg*min) | 0 to 12 hours after bolus infusion |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |