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

NCT ID: NCT05262595

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2022-09-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)

Group Type: EXPERIMENTAL

NNC0471-0119 A

Intervention Type: DRUG

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

Arm 2

A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)

Group Type: EXPERIMENTAL

NNC0471-0119 B

Intervention Type: DRUG

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

Arm 3

A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)

Group Type: EXPERIMENTAL

NNC0471-0119 D

Intervention Type: DRUG

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

Arm 4

A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)

Group Type: ACTIVE_COMPARATOR

Faster aspart

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male participant or female participant of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
• Aged 18-64 years (both inclusive) at the time of signing informed consent.
• Diagnosed with T1DM for more than1 year prior to the day of screening.
• Current total daily insulin treatment between 0.2 and 1.2 (I)U/kg/day (both inclusive).
• Treated with continuous subcutaneous insulin infusion greater than 90 days prior to the day of screening.

Exclusion Criteria

• Known or suspected hypersensitivity to study interventions or related products.
• Participation (i.e., study intervention) in any interventional, clinical study within 30 days or 5 times the half-life of the drug, whichever is longest before screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Graz, , Austria

Countries

Austria

Other Identifiers

U1111-1260-0359

Identifier Type: OTHER

Identifier Source: secondary_id

2020-005145-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1471-4752

Identifier Type: -

Identifier Source: org_study_id