Patient engagement impacts glycemic management with vildagliptin and vildagliptin/metformin (single pill) regimens in type 2 diabetes mellitus (the GLORIOUS study).
(en) Aims To evaluate the real-world effectiveness of vildagliptin and vildagliptin/metformin, combined with patient engagement, on glycemic outcomes. Patient engagement included both clinicians’ engaging patients through education and counseling; and patients’ self-engagement through disease awareness, lifestyle changes, and medication adherence. Methods Prospective, observational, open-label, multi-center, pharmacoepidemiologic study of type 2 diabetes mellitus (T2DM) patients treated de novo with vildagliptin or vildagliptin/metformin. Data were collected at baseline (treatment initiation), 105 ± 15 d, and ≥145 d. Results The evaluable sample included 896 mainly male (58%), overweight (mean ± SD BMI = 30.3 ± 5.4 kg/m2), in later middle age (mean ± SD age = 64 ± 11years) patients. Over the three visits, mean(±SD) HbA1c levels declined from 8.1%(±1.0) to 7.3%(±1.0) to 7.2%(±0.9); HbA1c control rates rose from 7% to 36% to 43%. Mean ± SD FPG levels decreased from 170(±49) to 141(±41) to 139(±42) mg/dL; control rates increased from 12% to 39% to 43% (all p < 0.0001). Weight decreased nominally by 2 kg (p = 0.0290) and BMI by 0.8 kg/m2 (p < 0.0001). Modeling showed patient engagement activities by clinicians and by patients to be major determinants of glycemic outcomes. No unknown safety signals were detected. Conclusions Vildagliptin and vildagliptin/metformin are effective and safe oral agents in the management of T2DM, especially if part of a treatment program with active patient engagement by clinicians and empowered patients.
Hermans, M., Van Gaal, L., Rézette, I., Daci, E., MacDonald, K., Denhaerynck, K., Vancayzeele, S., De Meester, L., Clemens, A., Yee, B., & Abraham, I. (2016). Patient engagement impacts glycemic management with vildagliptin and vildagliptin/metformin (single pill) regimens in type 2 diabetes mellitus (the GLORIOUS study). Primary Care Diabetes, 10(6), 425-433. https://doi.org/10.1016/j.pcd.2016.05.008 (Original work published 2016)