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

NCT06809621 | Completed Phase 1

• 3 other identifiers: NN1471-7712U1111-1306-80052024-513472-18
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

• 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

• GIR(max,basal-corrected): Maximum observed basal-corrected GIR

  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

  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

  0 to 9 hours after bolus infusion

Study Arms (2)

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.

Drug: NNC0471-0119 H; Drug: Insulin aspart

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.

Drug: NNC0471-0119 H; Drug: Insulin aspart

Interventions

NNC0471-0119 H DRUG

NNC0471-0119 H will be administered subcutaneously.

Insulin Aspart then NNC0471-0119 H; NNC0471-0119 H then Insulin Aspart

Insulin aspart DRUG

Insulin aspart will be administered subcutaneously.

Insulin Aspart then NNC0471-0119 H; NNC0471-0119 H then Insulin Aspart

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 5, 2025
• Study Start: January 29, 2025
• Primary Completion: July 16, 2025
• Study Completion: July 28, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)