A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting

Last updated: May 22, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

1

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

Insulin icodec

Insulin degludec

Clinical Study ID

NCT06288412
NN1436-7615
U1111-1285-1665
2023-505012-38
  • Ages 18-75
  • All Genders

Study Summary

The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.

  • Male or female.

  • Age 18-75 years (both inclusive) at the time of signing the informed consent.

  • Body mass index between 18.0 and 38.0 kilogram per meter^2 (kg/m^2) (bothinclusive).

  • Glycated hemoglobin (HbA1c) less than or equal to (<=) 9 percent (75 millimoles permole [mmol/mol]) at screening.

  • Treated with basal insulin with or without any of the following anti-diabeticdrugs/regimens with stable doses >= 90 days prior to the day of screening:

  • Metformin,

  • Dipeptidyl peptidase 4 (DPP-4) inhibitors,

  • Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors

  • Oral combination products (for the allowed individual oral antidiabetic drugs),Injectable and oral glucagon-like peptide 1 (GLP-1) Receptor Agonists.

  • Physically active >= 300 metabolic equivalent of task (MET) minutes/week asdetermined by an International Physical Activity Questionnaire (IPAQ) at screening.

  • Mass-specific oxygen volume (VO2) peak greater than (>) 25 milliliters per kilogramper minute (mL/kg/min) as determined by cardiopulmonary testing (CPX) test atscreening.

Exclusion

Exclusion Criteria:

  • Known or suspected hypersensitivity to study intervention(s) or related products.

  • Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using adequate contraceptive method.

  • Presence or history of cardiovascular disease including stable and unstable anginapectoris, myocardial infarction, transient ischaemic attack, stroke, cardiacdecompensation, clinically significant arrhythmias or clinically significantconduction disorders within 180 days prior to the day of screening.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Insulin icodec
Phase: 1
Study Start date:
February 26, 2024
Estimated Completion Date:
April 14, 2025

Connect with a study center

  • Medical University of Graz

    Graz, 8010
    Austria

    Site Not Available

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