This study is being conducted to find out how well zenagamtide works and how safe it is compared to insulin glargine in participants with type 2 diabetes who are at higher risk of heart and blood vessel problems and are already taking 1 to 3 diabetes medications. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance.
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 (sex assigned at birth, inclusive of all gender identities).
Age 45 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days before screening.
Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
Planned coronary, carotid or peripheral artery revascularisation.
Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening. However, insulin treatment for gestational diabetes is allowed as well as short term insulin treatment for a maximum of 14 consecutive days.
Parallel
Zenagamtide
DrugZenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm (administration to the same body part throughout the study).
Insulin glargine U-100
DrugInsulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts).
Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)
Measured as percentage (%)-points
Time to first occurrence of a 4-point major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina
Measured as days
Relative change in body weight
Measured as percentage (%) change
Superiority of zenagamtide versus insulin: Change in HbA1c
Measured as %-points
Time to first occurrence of a 3-point MACE endpoint consisting of: CV death, non-fatal myocardial infarction and non-fatal stroke
Measured as Days
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