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Clinical Trial Details

Trial ID: L3867
Source ID: NCT06288412
Associated Drug: Insulin Icodec
Title: 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
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin icodec|DRUG: Insulin degludec
Outcome Measures: 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|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
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-26
Completion Date: 2025-04-14
Results First Posted:
Last Update Posted: 2025-03-21
Locations: Medical University of Graz, Graz, 8010, Austria
URL: https://clinicaltrials.gov/show/NCT06288412