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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-11

Study Completion Date

2026-01-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

Diabetes Mellitus, Type 1

COMPLETED PHASE1

A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump

NCT05262595

Diabetes Mellitus, Type 1

COMPLETED PHASE1

A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Body When Given Through an Insulin Pump to People With Type 1 Diabetes

NCT03215498

Diabetes Diabetes Mellitus, Type 1

COMPLETED PHASE1

Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

NCT02825251

Diabetes Diabetes Mellitus, Type 1

COMPLETED PHASE3

A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus

NCT03723759

Diabetes Mellitus, Type 1

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

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

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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%

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

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No