A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin Pump

Phase 1

Recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: NNC0471-0119 H; Drug: Insulin aspart

• Registration Number: NCT06809621
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-28
• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-07-06
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NNC0471-0119 H then Insulin Aspart	NNC0471-0119 H	Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.
NNC0471-0119 H then Insulin Aspart	Insulin aspart	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	Insulin aspart	Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.
Insulin Aspart then NNC0471-0119 H	NNC0471-0119 H	Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany