Collecting Real-World Patient Reported Outcome Through Community Pharmacies A Pilot Exploratory Study Applied on the Effects of Introducing the Fixed Dose Combination Xultophy in the Management of Type 2 Diabetes Mellitus

Abstract This article addresses the possibility to initiate Fixed Dose Combination (FDC) therapy in form of Xultophy without prior exposure to the individual active entities of the FDC in Type 2 Diabetic Mellitus (T2DM) patients. This study used real-world patient reported outcomes (PROs) measures to compare FDC product intended for the three therapies (initial therapy, add-on therapy and substitution therapy) tested under real-world clinical practice using community pharmacy setting. The collected Patient Reported Outcomes (PROs) during the real-world clinical practice might be compared to the PROs used under controlled clinical trial settings to support labelling claims, facilitate decision making and gain authority approval. It was found that the real-world data collected may give valuable data useful for both the authority and the physician’ decision when it comes to select the suitable treatment for the individual patient.