Ramírez-Rincón, Alex http://orcid.org/0000-0002-3925-6201
Henao-Carrillo, Diana http://orcid.org/0000-0002-1353-148X
Omeara, Miguel http://orcid.org/0000-0002-8345-6155
Oliveros, Julio
Assaf, José
Ordóñez, Jaime E. http://orcid.org/0000-0002-4425-2555
Prasad, Preethy
Alzate, María Alejandra http://orcid.org/0009-0006-6247-6049
Clinical trials referenced in this document:
Documents that mention this clinical trial
SPIRIT: Assessing Clinical Parameters Associated with Using IDegLira in Patients with Type 2 Diabetes in a Real-World Setting in Colombia
https://doi.org/10.1007/s13300-024-01593-8
Funding for this research was provided by:
Novo Nordisk Colombia
Article History
Received: 7 March 2024
Accepted: 17 April 2024
First Online: 8 May 2024
Declarations
:
: María Alejandra Alzate and Preethy Prasad are employees of Novo Nordisk. Alex Ramírez-Rincón, Diana Henao-Carrillo, Miguel Omeara, Julio Oliveros, José Assaf and Jaime E. Ordóñez have no conflicts of interest to declare.
: The ethical considerations for this protocol are based on the Declaration of Helsinki and the Ethical Guidelines for Health-Related Research with Human Beings prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). The protocol was approved by the ethics committees or Institution Review Boards (IRBs) of all participating institutions, and by The National Institute of Drug and Food Surveillance (INVIMA) under number NN9068-4884. This study complies with the Colombian Ministry of Health’s Resolution 8430 and was considered to be a no risk study that did not require consent from participants. No consent from participants to publish was required because no identifiable information is presented in the results. The Board approved the clinical trial research protocol on Ethics Research of ten Health Insurers Companies, Hospitals, or Healthcare Centers of Colombia: Institute of Cardiology La Cardio, FRC Ambulatory Unit, Bluecare Research Center, University Hospital San Ignacio, IPS Cabeceras, Funcentra, Integral Diabetes Clinic, EPS Salud Total, Center for Diabetes and Metabolism CEDYM, and Sura diagnostic aids. Details of each center’s contribution and IRB approval are provided in the Electronic Supplementary Material.