Clinical trial NCT06288412: 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
Official title: Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: 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)
timeFrame: 0-24 hours after start of exercise at Day 38
Secondary outcomes:
measure: Time below range, glucose <3.9 mmol/L (70 mg/dL) within 24 hours after start of exercise (TBR3.9mmol/L,exe)
timeFrame: 0-24 hours after start of exercise at Day 38
measure: 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)
timeFrame: 0-24 hours after start of exercise at Day 38
measure: Time above range, glucose >10 mmol/L (180 mg/dL) within 24 hours after start of exercise (TAR10.0mmol/L,exe)
timeFrame: 0-24 hours after start of exercise at Day 38
measure: Number of clinically significant hypoglycaemic episodes during exercise (Hypoexe)
timeFrame: 0-40 minutes after start of exercise at Day 38
measure: Amount of carbohydrate intake during exercise (CHOexe)
timeFrame: 0-40 minutes after start of exercise at Day 38
measure: Amount of carbohydrate intake from end of standardised lunch meal until start of exercise (CHOpre-exe)
timeFrame: 0-90 minutes before start of exercise at Day 38
measure: Amount of carbohydrate intake after stop of exercise until start of standardised dinner meal (CHOpost-exe)
timeFrame: 0-140 minutes after start of exercise at Day 38
measure: Number of hypoglycaemic within 24 hours after start of exercise (Hypo24h,exe)
timeFrame: 0-24 hours after start of exercise at Day 38
measure: Number of hypoglycaemic episodes for 24 hours in reference week (43 to 67 hours after dosing) (Hypo24h,ref)
timeFrame: 43-67 hours after dosing at Day 29
measure: Time below range, glucose <3.0 mmol/L (54 mg/dL) within 18 hours after start of fasting (TBR3.0mmol/L,fast)
timeFrame: 0-18 hours after start of fasting at Day 44
measure: Time below range, glucose <3.9 mmol/L (70 mg/dL) within 18 hours after start of fasting (TBR3.9mmol/L,fast)
timeFrame: 0-18 hours after start of fasting at Day 44
measure: 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)
timeFrame: 0-18 hours after start of fasting at Day 44
measure: Time above range, glucose >10 mmol/L (180 mg/dL) within 18 hours after start of fasting (TAR10.0mmol/L,fast)
timeFrame: 0-18 hours after start of fasting at Day 44
measure: Number of clinically significant hypoglycaemic episodes during fasting (Hypofast)
timeFrame: 0-18 hours after start of fasting at Day 44
measure: Amount of carbohydrate administered intravenously during fasting (CHOfast)
timeFrame: 0-18 hours after start of fasting at Day 44
measure: Number of hypoglycaemic episodes within 18 hours after start of fasting (Hypo18h,fast)
timeFrame: 0-18 hours after start of fasting at Day 44
measure: Number of hypoglycaemic episodes for 18 hours in reference week (26 to 44 hours after dosing) (Hypo18h,ref)
timeFrame: 26-44 hours after dosing at Day 29
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: