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

NCT05134987 | Completed Phase 1

• 3 other identifiers: NN1845-4886U1111-1266-41622021-003271-33
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• AUCPG,0.5-2h Area under the plasma glucose-time curve at steady concentrations

  messured in h\*mmol/L

  From 0.5 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)

Secondary Outcomes (6)

• AUCPG,0-1h Area under the plasma glucose-time curve at steady concentrations

  From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)

• AUCPG,0-2hArea under the plasma glucose-time curve at steady concentrations

  From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)

• AUCPG,0-4h Area under the plasma glucose-time curve at steady concentrations

  From 0 to 4 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)

• ∆PGav,0-1h Mean change in plasma glucose at steady concentrations

  From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)

• ∆PGav,0-2h Mean change in plasma glucose at steady concentrations

  From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)

Study Arms (2)

NNC0363-0845 followed by insulin detemir

EXPERIMENTAL

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.

Drug: NNC0363-0845

Insulin detemir followed by NNC0363-0845

EXPERIMENTAL

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.

Drug: Insulin detemir

Interventions

NNC0363-0845 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

NNC0363-0845 followed by insulin detemir

Insulin detemir 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

Insulin detemir followed by NNC0363-0845

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

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. 1452)

  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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 26, 2021
• Study Start: December 1, 2021
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)