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OpenTrials
Completed

NCT Number: NCT06809621

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0471-0119 H

Drug

NNC0471-0119 H will be administered subcutaneously.

insulin aspart

Drug

Insulin aspart will be administered subcutaneously.

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

    Time frame: 0 to 1 hour after bolus infusion

    Measured in milligram per kilogram (mg/kg).

Secondary outcomes

  1. AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t

    Time frame: 0 to 9 hours after bolus infusion

    Measured in milligram per kilogram (mg/kg).

  2. 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

    Time frame: 0 to 9 hours after bolus infusion

    Measured in percentage (%).

  3. GIR(max,basal-corrected): Maximum observed basal-corrected GIR

    Time frame: 0 to 9 hours after bolus infusion

    Measured in milligrams per kilogram *minute (mg/[kg*min]).

  4. 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

    Time frame: 0 to 9 hours after bolus infusion

    Measured in percentage (%).

  5. AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t

    Time frame: 0 to 9 hours after bolus infusion

    Measured in hours*picomole per liter (h*pmol/L).

  6. AUC(NNC0471-0119,0-30min,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes

    Time frame: 0 to 30 minutes after bolus infusion

    Measured in h*pmol/L.

  7. 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)

    Time frame: 2 to 9 hours after bolus infusion

    Measured in h*pmol/L.

  8. 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

    Time frame: 0 to 9 hours after bolus infusion

    Measured in percentage (%).

  9. C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration

    Time frame: 0 to 9 hours after bolus infusion

    Measured in picomoles per litre (pmol/L).

  10. t(early50%Cmax,NNC0471-0119,basal-corrected): Time to early 50% maximum observed basal-corrected serum NNC0471-0119 concentration

    Time frame: 0 to 9 hours after bolus infusion

    Measured in minutes (Min).

  11. t(late50%Cmax,NNC0471-0119,basal-corrected): Time to late 50% maximum observed basal-corrected serum NNC0471-0119 concentration

    Time frame: 0 to 9 hours after bolus infusion

    Measured in minutes (Min).

  12. Number of adverse events (AEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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