MedicalResearch.com Interview with: Dr David Strain, MRCP MD Clinical senior lecturer and honorary consultant University of Exeter Medical School Institute of Biomedical and Clinical Science Department of Diabetes and Vascular Research Royal Devon & Exeter Hospital Exeter EX2 5AX MedicalResearch.com: What is the Background of the study? In early 2010 recent diabetes outcome trials such as ACCORD and ADVANCE had put into question the benefit of aggressive HbA1c reduction for all patients particularly in elderly population. After that there were several guidelines that suggested individualizing treatment targets for elderly patients according to their age, co-morbidities, frailty and baseline HbA1c. This featured in the Finnish guidelines and the European Working Party for the management of Diabetes in the Older Person. However this was also completely without any evidence base. I worked with Paivi Paldanius (the final author of the paper and a medical advisor for Novartis) to establish a pragmatic study. We both acknowledged the importance of having a patient-centric, pragmatic and 'real-life' approach and as there was already evidence that DPP-4 inhibitors, in this case vildagliptin (due to Päivi's affiliation), had demonstrated it's efficacious and had no tolerability issues in the elderly population we decided to go ahead with the study. It was obvious that we needed to implement a holistic approach and take into account as many clinically relevant parameters as possible, such as age, baseline HbA1c, duration of the disease, co-morbidities and frailty, for implementation of the individualized care. Our primary goal was to request that the physicians acting as investigators would still apply their clinical judgment based on these clinical features of each individual patient but also, follow their local guidelines as in their daily clinical practice. This would later provide us with invaluable information and perspective when interpreting the data and recommending implementation of the results.  For assessment of frailty we screened for many different methodologies but Prof Timo Strandberg (known expert of the field and mentioned in the acknowledgements section of our paper) suggested to apply modified Linda Fried's method for assessment of phenotype of frailty as this method is validated, very pragmatic, reproducible and also feasible to be used for the first time also by a non-geriatric investigator. All investigators were trained to follow these parameters by the protocol. We also wished to evaluate in parallel the conventional HbA1c drop assessment in order to be able to put the potential success of our new endpoint, meeting the individualized target, into perspective and for comparison against other standard data from other studies with DPP-4 inhibitors with elderly. We also wished to simulate a clinical, real-world setting as much as possible and included patients who would seem representative of most elderly T2DM patients. (more…)