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

Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin icodec; Drug: Insulin degludec

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities 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) (both inclusive).
• Glycated hemoglobin (HbA1c) less than or equal to (<=) 9 percent (75 millimoles per mole [mmol/mol]) at screening.

• Treated with basal insulin with or without any of the following anti-diabetic drugs/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 as determined by an International Physical Activity Questionnaire (IPAQ) at screening.
• Mass-specific oxygen volume (VO2) peak greater than (>) 25 milliliters per kilogram per minute (mL/kg/min) as determined by cardiopulmonary testing (CPX) test at screening.

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 of childbearing potential and not using adequate contraceptive method.
• Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders within 180 days prior to the day of screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin icodec; Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily in the run-in period and insulin icodec once weekly in the treatment period.	Drug: Insulin icodec; Participants will receive insulin icodec subcutaneous (s.c.) once weekly.; Drug: Insulin degludec; Participants will receive insulin degludec s.c. once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time below range, glucose less than (<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter [mg/dL]) within 24 hours after start of exercise (TBR3.0mmol/L,exe)	Measured in percentage of readings.	0-24 hours after start of exercise at Day 38

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time below range, glucose <3.9 mmol/L (70 mg/dL) within 24 hours after start of exercise (TBR3.9mmol/L,exe)	Measured in percentage of readings.	0-24 hours after start of exercise at Day 38
Time in range, glucose 3.9-10.0 mmol/L (70-180 mg/dL) within 24 hours after start of exercise (TIR3.9-10.0mmol/L,exe)	Measured in percentage of readings.	0-24 hours after start of exercise at Day 38
Time above range, glucose >10 mmol/L (180 mg/dL) within 24 hours after start of exercise (TAR10.0mmol/L,exe)	Measured in percentage of readings.	0-24 hours after start of exercise at Day 38
Number of clinically significant hypoglycaemic episodes during exercise (Hypoexe)	Measured as number of episodes.	0-40 minutes after start of exercise at Day 38
Amount of carbohydrate intake during exercise (CHOexe)	Measured in gram (g).	0-40 minutes after start of exercise at Day 38
Amount of carbohydrate intake from end of standardised lunch meal until start of exercise (CHOpre-exe)	Measured in g.	0-90 minutes before start of exercise at Day 38
Amount of carbohydrate intake after stop of exercise until start of standardised dinner meal (CHOpost-exe)	Measured in g.	0-140 minutes after start of exercise at Day 38
Number of hypoglycaemic within 24 hours after start of exercise (Hypo24h,exe)	Measured as number of episodes.	0-24 hours after start of exercise at Day 38
Number of hypoglycaemic episodes for 24 hours in reference week (43 to 67 hours after dosing) (Hypo24h,ref)	Measured as number of episodes.	43-67 hours after dosing at Day 29
Time below range, glucose <3.0 mmol/L (54 mg/dL) within 18 hours after start of fasting (TBR3.0mmol/L,fast)	Measured in percentage of readings.	0-18 hours after start of fasting at Day 44
Time below range, glucose <3.9 mmol/L (70 mg/dL) within 18 hours after start of fasting (TBR3.9mmol/L,fast)	Measured in percentage of readings.	0-18 hours after start of fasting at Day 44
Time in range, glucose 3.9-10 mmol/L (70-180 mg/dL) within 18 hours after start of fasting (TIR3.9-10.0mmol/L,fast)	Measured in percentage of readings.	0-18 hours after start of fasting at Day 44
Time above range, glucose >10 mmol/L (180 mg/dL) within 18 hours after start of fasting (TAR10.0mmol/L,fast)	Measured in percentage of readings.	0-18 hours after start of fasting at Day 44
Number of clinically significant hypoglycaemic episodes during fasting (Hypofast)	Measured as number of episodes.	0-18 hours after start of fasting at Day 44
Amount of carbohydrate administered intravenously during fasting (CHOfast)	Measured in g.	0-18 hours after start of fasting at Day 44
Number of hypoglycaemic episodes within 18 hours after start of fasting (Hypo18h,fast)	Measured as number of episodes.	0-18 hours after start of fasting at Day 44
Number of hypoglycaemic episodes for 18 hours in reference week (26 to 44 hours after dosing) (Hypo18h,ref)	Measured as number of episodes.	26-44 hours after dosing at Day 29

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Actual): March 10, 2025
• Study Completion (Actual): April 14, 2025

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Hypoglycemic Agents; insulin icodec; insulin degludec
• Other Study ID Numbers: NN1436-7615; U1111-1285-1665 (Other Identifier: World Health Organization (WHO)); 2023-505012-38 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No