Diabetes Mellitus, Type 1
Conditions
Brief summary
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.
Interventions
DRUGNNC0471-0119 H
NNC0471-0119 H will be administered subcutaneously.
DRUGInsulin aspart
Insulin aspart will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18-64 years (both inclusive) at the time of signing the informed consent. * Diagnosed with Type 1 Diabetes (T1D) greater than or equal to (≥) 1 year before screening. * Insulin administration using continuous subcutaneous insulin infusion via a pump greater than or equal to (≥) 90 days before screening. * Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day \[(I)U/kg/day\] (both inclusive).
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour | 0 to 1 hour after bolus infusion | Measured in milligram per kilogram (mg/kg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t | 0 to 9 hours after bolus infusion | Measured in milligram per kilogram (mg/kg). |
| 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 | 0 to 9 hours after bolus infusion | Measured in percentage (%). |
| GIR(max,basal-corrected): Maximum observed basal-corrected GIR | 0 to 9 hours after bolus infusion | Measured in milligrams per kilogram \*minute (mg/\[kg\*min\]). |
| 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 | 0 to 9 hours after bolus infusion | Measured in percentage (%). |
| AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t | 0 to 9 hours after bolus infusion | Measured in hours\*picomole per liter (h\*pmol/L). |
| AUC(NNC0471-0119,0-30min,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes | 0 to 30 minutes after bolus infusion | Measured in h\*pmol/L. |
| 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) | 2 to 9 hours after bolus infusion | Measured in h\*pmol/L. |
| 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 | 0 to 9 hours after bolus infusion | Measured in percentage (%). |
| C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration | 0 to 9 hours after bolus infusion | Measured in picomoles per litre (pmol/L). |
| t(early50%Cmax,NNC0471-0119,basal-corrected): Time to early 50% maximum observed basal-corrected serum NNC0471-0119 concentration | 0 to 9 hours after bolus infusion | Measured in minutes (Min). |
| t(late50%Cmax,NNC0471-0119,basal-corrected): Time to late 50% maximum observed basal-corrected serum NNC0471-0119 concentration | 0 to 9 hours after bolus infusion | Measured in minutes (Min). |
| Number of adverse events (AEs) | 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) | Measure in number of events. |
Countries
Germany
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed