Elevated Cardiovascular Risk and Mortality in Type 2 Diabetes Mellitus Patients With Cannabis, Opioid, and Cocaine Use Disorders.

The trial was approved by the European Medicines Agency (EUDRACT No. 2021-000874-28), the National Medical Agency (2021–1041858), the National Scientific Committee (S-20210054), the Regional Ethics Committee (De Videnskabsetiske Komitéer for Region Syddenmark) (22/22766), and the Unit of Good Clinical Practice (22.011). The study was registered at ClinicalTrials.gov () on June 1, 2022. Data were stored in a closed repository within the Open Patient data Explorative Network (OPEN) at the University of Southern Denmark using a REDCap database (No. 1377). Randomization was performed using Ciba-Geigy random numbers (even or odd) prior to trial initiation and stored in sealed envelopes. All participants received written and oral information and provided written informed consent. The study was monitored by OPEN in accordance with Good Clinical Practice (GCP) guidelines.