nctId: NCT06288412 id: NN1436-7615 id: U1111-1285-1665 type: OTHER domain: World Health Organization (WHO) id: 2023-505012-38 type: OTHER domain: European Medical Agency (EMA) briefTitle: 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 overallStatus: RECRUITING date: 2024-02-26 date: 2024-11-04 date: 2024-11-04 date: 2024-03-01 date: 2024-04-02 name: Novo Nordisk A/S class: INDUSTRY briefSummary: 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. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Insulin icodec name: Insulin degludec 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) measure: Time below range, glucose <3.9 mmol/L (70 mg/dL) within 24 hours after start of exercise (TBR3.9mmol/L,exe) 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) measure: Time above range, glucose >10 mmol/L (180 mg/dL) within 24 hours after start of exercise (TAR10.0mmol/L,exe) measure: Number of clinically significant hypoglycaemic episodes during exercise (Hypoexe) measure: Amount of carbohydrate intake during exercise (CHOexe) measure: Amount of carbohydrate intake from end of standardised lunch meal until start of exercise (CHOpre-exe) measure: Amount of carbohydrate intake after stop of exercise until start of standardised dinner meal (CHOpost-exe) measure: Number of hypoglycaemic within 24 hours after start of exercise (Hypo24h,exe) measure: Number of hypoglycaemic episodes for 24 hours in reference week (43 to 67 hours after dosing) (Hypo24h,ref) measure: Time below range, glucose <3.0 mmol/L (54 mg/dL) within 18 hours after start of fasting (TBR3.0mmol/L,fast) measure: Time below range, glucose <3.9 mmol/L (70 mg/dL) within 18 hours after start of fasting (TBR3.9mmol/L,fast) 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) measure: Time above range, glucose >10 mmol/L (180 mg/dL) within 18 hours after start of fasting (TAR10.0mmol/L,fast) measure: Number of clinically significant hypoglycaemic episodes during fasting (Hypofast) measure: Amount of carbohydrate administered intravenously during fasting (CHOfast) measure: Number of hypoglycaemic episodes within 18 hours after start of fasting (Hypo18h,fast) measure: Number of hypoglycaemic episodes for 18 hours in reference week (26 to 44 hours after dosing) (Hypo18h,ref) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz status: RECRUITING city: Graz zip: 8010 country: Austria lat: 47.06667 lon: 15.45 hasResults: False