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