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

NCT06685185 | Completed Phase 1

• 3 other identifiers: NN1644-77942024-511808-17U1111-1304-2544
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

• Part 1 SAD: Number of adverse events

  Measured in number of events.

  From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)

• Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose

  Measured in millilitre per hour\*kilogram (mL/\[h\*kg\]).

  From IMP administration at day 1 up to 7 days

• Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state

  Measured in hours\*millimoles per litre (h\*mmol/L).

  At day 2 of visit 2 and visit 3 after initiation of meal test

Secondary Outcomes (19)

• Part 1 SAD: Number of hypoglycaemic episodes

  From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)

• Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose

  Up to 7 days

• Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose

  Up to 2 days

• Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose

  Up to 7 days

• Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose

  Up to 7 days

Study Arms (7)

Part 1A: SAD: NNC0363-1063

EXPERIMENTAL

Participants will receive single dose of NNC0363-1063 subcutaneously.

Drug: NNC0363-1063

Part 1A: SAD: Placebo

PLACEBO COMPARATOR

Participants will receive NNC0363-1063 matching placebo subcutaneously.

Drug: Placebo

Part 1B: SAD: NNC0363-1063

EXPERIMENTAL

Participants will receive NNC0363-1063 subcutaneously.

Drug: NNC0363-1063

Part 1B: SAD: Insulin degludec

ACTIVE COMPARATOR

Participants will receive insulin degludec subcutaneously.

Drug: Insulin degludec

Part 2: PoP: NNC0363-1063

EXPERIMENTAL

Participants will receive NNC0363-1063 subcutaneously.

Drug: NNC0363-1063

Part 3 Meal test: NNC0363-1063

EXPERIMENTAL

Participants will receive NNC0363-1063 subcutaneously.

Drug: NNC0363-1063

Part 3 Meal test: Insulin detemir

ACTIVE COMPARATOR

Participants will receive insulin detemir subcutaneously.

Drug: Insulin detemir

Interventions

NNC0363-1063 DRUG

NNC0363-1063 will be administered subcutaneously.

Part 1A: SAD: NNC0363-1063; Part 1B: SAD: NNC0363-1063; Part 2: PoP: NNC0363-1063; Part 3 Meal test: NNC0363-1063

Placebo DRUG

Placebo will be administered subcutaneously.

Part 1A: SAD: Placebo

Insulin degludec DRUG

Insulin degludec will be administered subcutaneously.

Also known as: Tresiba

Part 1B: SAD: Insulin degludec

Insulin detemir DRUG

Insulin detemir will be administered subcutaneously.

Also known as: Levemir

Part 3 Meal test: Insulin detemir

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin degludec; Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 12, 2024
• Study Start: November 12, 2024
• Primary Completion: March 8, 2026
• Study Completion: March 18, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)