Cardiovascular outcomesA trial investigating the cardiovascular safety of oral semaglutide insubjects with type 2 diabetes

ovo Nordisk India Private Ltd0 sites201 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 21, 2018

Last Updated

4 years ago

Study Type

Interventional

Sponsor

ovo Nordisk India Private Ltd

•1\. Informed consent obtained before any trial\-related activities. Trial\-related activities are any
•procedures that are carried out as part of the trial, including activities to determine suitability
•for the trial.
•2\. Male or female diagnosed with type 2 diabetes.
•3\. Age \>\= 50 years at screening and at least one of the below conditions:
•a. prior myocardial infarction
•b. prior stroke or transient ischaemic attack (TIA)
•c. prior coronary, carotid or peripheral arterial revascularisation
•d. \> 50% stenosis on angiography or imaging of coronary, carotid or lower
•extremity arteries

•1\. Known or suspected hypersensitivity to the trial product or related products.
•2\. Previous participation in this trial. Participation is defined as signed informed consent. 3\. Female who is pregnant, breast\-feeding or intends to become pregnant or is of childbearing
•potential and not using adequate contraceptive methods (adequate contraceptive measures as
•required by local regulation or practice. Local country regulations or practices are specified
•in section 8 of the protocol).
•4\. Receipt of any investigational medicinal product within 90 days before screening.
•For Brazil only: Participation in other clinical trials within one year prior to screening
•unless there is a direct benefit to the research subject at the investigatorÂ´s discretion.
•5\. Participation in another clinical trial of an investigational medicinal product. Participation in
•a clinical trial which evaluate stent(s) is allowed.