Skip to main content
OpenTrials
Completed

NCT Number: NCT05134987

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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%.

Key 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.

Treatment and study plan

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

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

Primary outcomes

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

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

    messured in h*mmol/L

Secondary outcomes

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

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

    messured in h*mmol/L

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

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

    messured in h*mmol/L

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

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

    messured in h*mmol/L

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

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

    messured in mmol/L

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

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

    messured in mmol/L

  6. Number of adverse events

    Time frame: From first IMP administration until 16 hours after last IMP administration (visit 4 day 3 and visit 5 day 3)

    Number of events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2021
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.