A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2026-05-15

Brief Summary

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This study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1 diabetes (T1D). This study part will last for about 1½ to 5½ weeks. Part 2 is a proof-of-principle (PoP) study part conducted in participants with T1D and will last for about 3½ to 8½ weeks. Part 3 is a meal test multiple dose study part conducted in participants with T1D and will last for 7 to 11 weeks.

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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

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Part 1 SAD and Part 3 Meal test are double-blind study parts. Sponsor staff involved in the clinical trial is masked according to company standard procedures. Part 2 is open-label study part.

Study Groups

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Part 1A: SAD: NNC0363-1063

Participants will receive single dose of NNC0363-1063 subcutaneously.

Group Type EXPERIMENTAL

NNC0363-1063

Intervention Type DRUG

NNC0363-1063 will be administered subcutaneously.

Part 1A: SAD: Placebo

Participants will receive NNC0363-1063 matching placebo subcutaneously.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered subcutaneously.

Part 1B: SAD: NNC0363-1063

Participants will receive NNC0363-1063 subcutaneously.

Group Type EXPERIMENTAL

NNC0363-1063

Intervention Type DRUG

NNC0363-1063 will be administered subcutaneously.

Part 1B: SAD: Insulin degludec

Participants will receive insulin degludec subcutaneously.

Group Type ACTIVE_COMPARATOR

Insulin degludec

Intervention Type DRUG

Insulin degludec will be administered subcutaneously.

Part 2: PoP: NNC0363-1063

Participants will receive NNC0363-1063 subcutaneously.

Group Type EXPERIMENTAL

NNC0363-1063

Intervention Type DRUG

NNC0363-1063 will be administered subcutaneously.

Part 3 Meal test: NNC0363-1063

Participants will receive NNC0363-1063 subcutaneously.

Group Type EXPERIMENTAL

NNC0363-1063

Intervention Type DRUG

NNC0363-1063 will be administered subcutaneously.

Part 3 Meal test: Insulin detemir

Participants will receive insulin detemir subcutaneously.

Group Type ACTIVE_COMPARATOR

Insulin detemir

Intervention Type DRUG

Insulin detemir will be administered subcutaneously.

Interventions

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NNC0363-1063

NNC0363-1063 will be administered subcutaneously.

Intervention Type DRUG

Placebo

Placebo will be administered subcutaneously.

Intervention Type DRUG

Insulin degludec

Insulin degludec will be administered subcutaneously.

Intervention Type DRUG

Insulin detemir

Insulin detemir will be administered subcutaneously.

Intervention Type DRUG

Other Intervention Names

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Tresiba Levemir

Eligibility Criteria

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Inclusion Criteria

Part 1A SAD (healthy participants)

* Male or female of non-child bearing 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.
* Age 18-64 years (both inclusive) at the time of signing the informed consent.
* Body mass index between 18.5-29.9 kilogram per square metre( kg/m\^2) (both inclusive) at the day of screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)

* Male or female of non-child bearing 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.
* Age 18-64 years (both inclusive) at the time of signing the informed consent.
* Body mass index between 18.5-29.9 kg/m\^2 (both inclusive) at the day of screening.
* Diagnosed with type 1 diabetes mellitus greater than or equal to( ≥)1 year prior to the day of screening.
* Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria

Part 1A SAD (healthy participants)

* Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
* Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)

* Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
* Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes