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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-29

Study Completion Date

2025-07-28

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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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.

Group Type EXPERIMENTAL

NNC0471-0119 H

Intervention Type DRUG

NNC0471-0119 H will be administered subcutaneously.

Insulin aspart

Intervention Type DRUG

Insulin aspart will be administered subcutaneously.

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.

Group Type ACTIVE_COMPARATOR

NNC0471-0119 H

Intervention Type DRUG

NNC0471-0119 H will be administered subcutaneously.

Insulin aspart

Intervention Type DRUG

Insulin aspart will be administered subcutaneously.

Interventions

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NNC0471-0119 H

NNC0471-0119 H will be administered subcutaneously.

Intervention Type DRUG

Insulin aspart

Insulin aspart will be administered subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No