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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1306-8005 | Other Identifier | World Health Organization (WHO) | |
| 2024-513472-18 | Other Identifier | European Medical Agency (EMA) |
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The study is looking at the effect and safety of a new fast-acting insulin (NNC0471 0119) to people with type 1 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters your bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The participants will get each study medicine administered at separate clinic visits. The study will last for about 1-3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0471-0119 H then Insulin Aspart | Experimental | Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2. |
|
| Insulin Aspart then NNC0471-0119 H | Active Comparator | Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0471-0119 H | Drug | NNC0471-0119 H will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour | Measured in milligram per kilogram (mg/kg). | 0 to 1 hour after bolus infusion |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t | Measured in milligram per kilogram (mg/kg). | 0 to 9 hours after bolus infusion |
| AUC(GIR,0-1h,basal-corrected)/AUC(GIR,0-t,basalcorrected):Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t |
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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 |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
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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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Insulin aspart | Drug | Insulin aspart will be administered subcutaneously. |
|
Measured in percentage (%). |
| 0 to 9 hours after bolus infusion |
| GIR(max,basal-corrected): Maximum observed basal-corrected GIR | Measured in milligrams per kilogram *minute (mg/[kg*min]). | 0 to 9 hours after bolus infusion |
| AUC(NNC0471-0119,0-30min,basal corrected)/AUC(NNC0471-0119,0-t,basal-corrected):Ratio of basal-corrected area under serum NNC0471-0119 conc. time curve from 0-30min and 0-t | Measured in percentage (%). | 0 to 9 hours after bolus infusion |
| AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t | Measured in hours*picomole per liter (h*pmol/L). | 0 to 9 hours after bolus infusion |
| AUC(NNC0471-0119,0-30min,basal-corrected): 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 9 hours) | Measured in h*pmol/L. | 2 to 9 hours after bolus infusion |
| AUC(NNC0471-0119,2h-t,basal-corrected)/AUC(NNC0471-0119 H,0-t,basal-corrected):Ratio of basal corrected area under serum NNC0471-0119 conc. time curve from 2hrs-t and 0-t | Measured in percentage (%). | 0 to 9 hours after bolus infusion |
| C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration | Measured in picomoles per litre (pmol/L). | 0 to 9 hours after bolus infusion |
| t(early50%Cmax,NNC0471-0119,basal-corrected): Time to early 50% maximum observed basal-corrected serum NNC0471-0119 concentration | Measured in minutes (Min). | 0 to 9 hours after bolus infusion |
| t(late50%Cmax,NNC0471-0119,basal-corrected): Time to late 50% maximum observed basal-corrected serum NNC0471-0119 concentration | Measured in minutes (Min). | 0 to 9 hours after bolus infusion |
| Number of adverse events (AEs) | Measure in 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 4) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |