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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288412
• Other study ID #: NN1436-7615
• Secondary ID: U1111-1285-16652
• Status: Recruiting
• Phase: Phase 1
• Start date: February 26, 2024
• Est. completion date: November 4, 2024

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 4, 2024
• Est. primary completion date: November 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin icodec
Participants will receive insulin icodec subcutaneous (s.c.) once weekly.
• Insulin degludec
Participants will receive insulin degludec s.c. once daily.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of clinically significant hypoglycaemic episodes during exercise (Hypoexe)	Measured as number of episodes.	0-40 minutes after start of exercise at Day 38
Secondary	Amount of carbohydrate intake during exercise (CHOexe)	Measured in gram (g).	0-40 minutes after start of exercise at Day 38
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of clinically significant hypoglycaemic episodes during fasting (Hypofast)	Measured as number of episodes.	0-18 hours after start of fasting at Day 44
Secondary	Amount of carbohydrate administered intravenously during fasting (CHOfast)	Measured in g.	0-18 hours after start of fasting at Day 44
Secondary	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
Secondary	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