A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes Pharmacokinetics and Pharmacodynamics: How Insulin NNC0363-0845 is Transported Throughout the Body and How It Works

NCT ID: NCT05134987

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-05-06

Brief Summary

This study is designed to investigate the movement of insulin NNC0363-0845 throughout the body and how it works for the treatment of type 1 diabetes mellitus.

The aim of the study is to improve clinical outcomes for patients with type 1 diabetes mellitus by better controlling the blood sugar levels.

Participants will get insulin NNC0363-0845 as well as insulin detemir (Levemir®). NNC0363-0845 is a new insulin molecule designed to provide blood sugar-dependent insulin action, while insulin detemir is commonly used and prescribed by doctors.

Participants will get subcutaneous (under your skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days, and of insulin detemir up to 6 times daily for another 3 days. Which medication participants receive first and which second, insulin NNC0363-0845 or insulin detemir, is decided by chance.

The study will last for about 6 weeks up to a maximum of 14 weeks. Participants will have 2 in-house visits (where participants will stay at the site for 4 nights) and 5 outpatient visits with the study doctor. Participants will have frequent contact with the study doctor during the study.

During the in-house visits, two intravenous catheters (a thin tube inserted into a vein) will be inserted for blood sampling and infusions.

Interested parties may not participate in the study if the study doctor believes it will affect their health negatively.

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

NNC0363-0845 followed by insulin detemir

Participants will get subcutaneous (under the skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of insulin detemir up to 6 times daily for 3 days.

Group Type: EXPERIMENTAL

NNC0363-0845

Intervention Type: DRUG

Participants will receive 0.5 nmol/kg NNC0363-0845 s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 3 nmol/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks

Insulin detemir followed by NNC0363-0845

Participants will get subcutaneous (under the skin) injections of insulin detemir up to 6 times daily for 3 days. After a 4-21 days wash-out period with no injections they will get subcutaneous injections of NNC0363-0845 (study medicine) up to 6 times daily for 3 days.

Group Type: EXPERIMENTAL

Insulin detemir

Intervention Type: DRUG

Participants will receive 0.083 U/kg insulin detemir s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 0.5 U/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks

Interventions

NNC0363-0845

Participants will receive 0.5 nmol/kg NNC0363-0845 s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 3 nmol/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks

Intervention Type: DRUG

Insulin detemir

Participants will receive 0.083 U/kg insulin detemir s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 0.5 U/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male participant or female participant of non-childbearing potential. Non-child-bearing 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 type 1 diabetes mellitus 1 year or more before screening.
• Current daily basal insulin treatment greater than 0.2 and below or equal to 0.5 (I)U/kg/day.
• Current total daily insulin treatment between 0.4 and 0.8 (I)U/kg/day (both inclusive).
• Body mass index between 18.5-29.9 kg/m^2 (both inclusive).
• HbA1c (glycated haemoglobin) below or equal to 8.0%.

Exclusion Criteria

• Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male participant uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). In addition, participants must not donate sperm for the duration of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 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. 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Graz, , Austria

Countries

Austria

Other Identifiers

U1111-1266-4162

Identifier Type: OTHER

Identifier Source: secondary_id

2021-003271-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1845-4886

Identifier Type: -

Identifier Source: org_study_id