Phase
Condition
Diabetes And Hypertension
Diabetes Mellitus, Type 2
Diabetes Prevention
Treatment
Insulin icodec
Insulin degludec
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities 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) (bothinclusive).
Glycated hemoglobin (HbA1c) less than or equal to (<=) 9 percent (75 millimoles permole [mmol/mol]) at screening.
Treated with basal insulin with or without any of the following anti-diabeticdrugs/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 asdetermined by an International Physical Activity Questionnaire (IPAQ) at screening.
Mass-specific oxygen volume (VO2) peak greater than (>) 25 milliliters per kilogramper minute (mL/kg/min) as determined by cardiopulmonary testing (CPX) test atscreening.
Exclusion
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 ofchildbearing potential and not using adequate contraceptive method.
Presence or history of cardiovascular disease including stable and unstable anginapectoris, myocardial infarction, transient ischaemic attack, stroke, cardiacdecompensation, clinically significant arrhythmias or clinically significantconduction disorders within 180 days prior to the day of screening.
Study Design
Connect with a study center
Medical University of Graz
Graz, 8010
AustriaSite Not Available

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