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

A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of NNC0471-0119 H When Administered as Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: NNC0471-0119 H; Drug: Insulin aspart

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0471-0119 H then Insulin Aspart; Participants will receive NNC0471-0119 H subcutaneously (s.c.) in period 1 followed by insulin aspart s.c. in period 2.	Drug: NNC0471-0119 H; NNC0471-0119 H will be administered subcutaneously.; Drug: Insulin aspart; Insulin aspart will be administered subcutaneously.
Active Comparator: Insulin Aspart then NNC0471-0119 H; Participants will receive insulin aspart s.c. in period 1 followed by s.c. NNC0471-0119 H in period 2.	Drug: NNC0471-0119 H; NNC0471-0119 H will be administered subcutaneously.; Drug: Insulin aspart; Insulin aspart will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2025
• Primary Completion (Actual): July 16, 2025
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulins; Pancreatic Hormones; Insulin, Short-Acting; Insulin Aspart
• Other Study ID Numbers: NN1471-7712; U1111-1306-8005 (Other Identifier: World Health Organization (WHO)); 2024-513472-18 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No