Patient engagement impacts glycemic management with vildagliptin and vildagliptin/metformin (single pill) regimens in type 2 diabetes mellitus (the GLORIOUS study).

Hermans, Michel;Van Gaal, Luc;Rézette, Ingrid;Daci, Evis;Abraham, Ivo;et.al.
(2016) Primary Care Diabetes — Vol. 10, n° 6, p. 425-433 (2016)

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Authors
  • Hermans, MichelUCLouvain
    Author
  • Van Gaal, Luc
    Author
  • Rézette, Ingrid
    Author
  • Daci, Evis
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  • Abraham, Ivo
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Abstract
(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.
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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)