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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-10-12

No results posted yet for this study

Summary

This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump.

The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered.

The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®).

Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes.

Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance.

The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each.

During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions.

Women: Women cannot take part if they are of childbearing potential.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

NNC0471-0119 A

NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months

DRUG

NNC0471-0119 B

NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months

DRUG

NNC0471-0119 D

NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months

DRUG

Faster aspart

Faster aspart administered once via an insulin pump as one bolus dose on top of a continuous basal rate. The study will last 1-4 months

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2022-08-29
Completion
2022-09-05

Countries

  • Austria

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05262595 on ClinicalTrials.gov