A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 Diabetes When Given by an Insulin Pump

NCT07068295 | Recruiting Phase 1

• 3 other identifiers: NN1471-5026U1111-1283-05072024-520230-29
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at the effect and safety of a new fast-acting insulin (NNC0471-0119) in people with type 2 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters 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 study will last for about 13-67 days (or a half to 2 months).

Conditions

Diabetes Mellitus, Type 2

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 11 hours after bolus infusion

• AUC(GIR,0-1h,basal-corrected)/AUC(GIR,0-t,basal-corrected): Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t

  0 to 11 hours after bolus infusion

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

  0 to 11 hours after bolus infusion

• AUC(NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected): Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t

  0 to 11 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 11 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 - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (sex at birth).
• Age 18-69 years (both inclusive) at the time of signing the informed consent.
• Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening.
• Treated with any injectable insulin, except once-weekly insulin, ≥ 180 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) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening:
• Any metformin formulation
• Dipeptidyl peptidase-4 inhibitor (DPP4i)
• Sodium-glucose Cotransporter-2 inhibitor (SGLT2i)
• Body mass index (BMI) between 18.5 and 34.9 kg/m2 (both inclusive) at screening.
• HbA1c lesser than or equal to (≤) 9.5%

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

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

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: July 7, 2025
• First Posted: July 16, 2025
• Study Start: July 11, 2025
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)