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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1285-1665 | Other Identifier | World Health Organization (WHO) | |
| 2023-505012-38 | Other Identifier | European Medical Agency (EMA) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin icodec | Experimental | Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily in the run-in period and insulin icodec once weekly in the treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | Participants will receive insulin icodec subcutaneous (s.c.) once weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42387301 | Derived | Pieber TR, Bajaj HS, Fluhr G, Klein KR, Pagliaro Rocha TM, Sourij H, Svehlikova E, Udupa K, Watt SK, Willerslev-Olsen M, Ribel-Madsen R. Exercise or Fasting in Individuals With Type 2 Diabetes Receiving Once-Weekly Basal Insulin Icodec. Diabetes Obes Metab. 2026 Jul 1. doi: 10.1111/dom.71050. Online ahead of print. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000712207 | insulin icodec |
| C571886 | insulin degludec |
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| Insulin degludec | Drug | Participants will receive insulin degludec s.c. once daily. |
|
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 |
| D004700 | Endocrine System Diseases |