title: Patient engagement impacts glycemic management with vildagliptin and vildagliptin/metformin (single pill) regimens in type 2 diabetes mellitus (the GLORIOUS study).
abstract: 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.
  
  
  
  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±15d, and ≥145d.
  
  
  
  The evaluable sample included 896 mainly male (58%), overweight (mean±SD BMI=30.3±5.4kg/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 2kg (p=0.0290) and BMI by 0.8kg/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.
  
  
  
  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.
authors.affiliation: Cliniques Universitaires Saint-Luc, Avenue Hippocrate 55, B-1200 Bruxelles, Belgium. Electronic address: michel.hermans@uclouvain.be.
authors.forename: Michel
authors.initials: M
authors.lastname: Hermans
authors.affiliation: Universitair Ziekenhuis Antwerpen, Wilrijkstraat 10, B-2650 Edegem, Belgium. Electronic address: luc.van.gaal@uza.be.
authors.forename: Luc
authors.initials: L
authors.lastname: Van Gaal
authors.affiliation: Novartis Pharma, Medialaan 40, bus 1, B-1800 Vilvoorde, Belgium. Electronic address: ingrid.rezette@gmail.com.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Rézette
authors.affiliation: Novartis Pharma, Medialaan 40, bus 1, B-1800 Vilvoorde, Belgium. Electronic address: evis.daci@novartis.com.
authors.forename: Evis
authors.initials: E
authors.lastname: Daci
authors.affiliation: Matrix45, 6159 W Sunset Rd, Tucson, AZ, USA. Electronic address: kmacdonald@matrix45.com.
authors.forename: Karen
authors.initials: K
authors.lastname: MacDonald
authors.affiliation: Matrix45, 6159 W Sunset Rd, Tucson, AZ, USA. Electronic address: kdenhaerynck@matrix45.com.
authors.forename: Kris
authors.initials: K
authors.lastname: Denhaerynck
authors.affiliation: Novartis Pharma, Medialaan 40, bus 1, B-1800 Vilvoorde, Belgium. Electronic address: stefaan.vancayzeele@novartis.com.
authors.forename: Stefaan
authors.initials: S
authors.lastname: Vancayzeele
authors.affiliation: Novartis Pharma, Medialaan 40, bus 1, B-1800 Vilvoorde, Belgium. Electronic address: lut.demeester@novartis.com.
authors.forename: Lut
authors.initials: L
authors.lastname: De Meester
authors.affiliation: Novartis Pharma, Novartis Campus, CH-4056 Basel, Switzerland. Electronic address: andreas.clemens@novartis.com.
authors.forename: Andreas
authors.initials: A
authors.lastname: Clemens
authors.affiliation: Matrix45, 6159 W Sunset Rd, Tucson, AZ, USA. Electronic address: byee@matrix45.com.
authors.forename: Brian
authors.initials: B
authors.lastname: Yee
authors.affiliation: Matrix45, 6159 W Sunset Rd, Tucson, AZ, USA; Center for Health Outcomes and Pharmacoeconomic Research, University of Arizona, 1295 N Martin Ave, Tucson, AZ 85743, USA. Electronic address: iabraham@matrix45.com.
authors.forename: Ivo
authors.initials: I
authors.lastname: Abraham
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000284:Administration, Oral; D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D003376:Counseling; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D055118:Medication Adherence; D008687:Metformin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage* / Q000009:adverse effects; D010353:Patient Education as Topic; D010358:Patient Participation; D011446:Prospective Studies; D011759:Pyrrolidines / Q000008:administration & dosage* / Q000009:adverse effects; D040242:Risk Reduction Behavior; D012648:Self Care; D013607:Tablets; D016896:Treatment Outcome; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D015415:Biomarkers; D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D009570:Nitriles; D011759:Pyrrolidines; D013607:Tablets; D000077597:Vildagliptin; C517652:hemoglobin A1c protein, human
keywords: Diabetes mellitus; Dipeptidyl peptidase-4 inhibitor; Effectiveness; Outcomes; Type 2 diabetes mellitus; Vildagliptin