title: Implementing an optimized glucose-lowering strategy with a novel once daily modified release gliclazide formulation.
abstract: OBJECTIVE
  The 6-months titration profile of a new scored gliclazide modified release (MR) formulation (MR 60 mg) was explored in individuals with type 2 diabetes.
  
  
  METHODS
  This international study enrolled 7170 individuals, age ≥ 35 years with HbA1c ≥ 7.5% (59 mmol/mol) and not on insulin. Participants were started on 30-120 mg gliclazide MR 60 mg once daily as a first line (FIRST), add-on (ADD) or switch from a previous oral antihyperglycemic treatment strategy (SWITCH). Uptitration was capped at 120 mg.
  
  
  RESULTS
  Women comprised 58.5% of the cohort. Mean baseline age was 58.9 years, body mass index 30.1 kg/m(2) and diabetes duration 5.1 years. Mean baseline HbA1c for the FIRST (n=2023), ADD (n=3136) and SWITCH (n=1834) groups was 8.9% (74 mmol/mol), 8.8% (73 mmol/mol) and 8.8% (73 mmol/mol), respectively. Probability of reaching optimal dose at months 1, 2, 3 and 6 was 15%, 39%, 59% and 92%, respectively. Mean HbA1c changes from baseline to month 6 were FIRST: -1.98%, ADD: -1.74% and SWITCH: -1.61% (all p<0.01). Overall, 65.3% achieved HbA1c ≤ 7.0% (53 mmol/mol); average duration for achieving glucose control was 80.1 days. Mean weight loss ranged from -1.45 to -1.27 kg. Severe hypoglycemia was experienced by 0.06% of participants. Most (95.5%) indicated a greater likelihood of adherence with the gliclazide MR 60 mg regime relative to their previous therapy.
  
  
  CONCLUSIONS
  In this large, real world study, progressive uptitration with gliclazide MR 60 mg once daily appears to be efficacious and safe in individuals with suboptimal glycemic control at various stages of the diabetes continuum.
authors.affiliation: Divisions of Endocrinology & Metabolism, Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada. Electronic address: leiterl@smh.ca.
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Leiter
authors.affiliation: Endocrinology Research Centre, Moscow, Russian Federation; I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation.
authors.forename: Marina V
authors.initials: MV
authors.lastname: Shestakova
authors.affiliation: Endocrinology Research Centre, Moscow, Russian Federation.
authors.forename: Natalya P
authors.initials: NP
authors.lastname: Trubitsyna
authors.affiliation: General Hospital, Novo Mesto, Novo Mesto, Slovenia.
authors.forename: Milivoj
authors.initials: M
authors.lastname: Piletič
authors.affiliation: Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.
authors.forename: Ilhan
authors.initials: I
authors.lastname: Satman
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001786:Blood Glucose / Q000032:analysis*; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005907:Gliclazide / Q000008:administration & dosage*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D007328:Insulin / Q000627:therapeutic use; D008875:Middle Aged; D013997:Time Factors
chemical_list: D001786:Blood Glucose; D005907:Gliclazide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Gliclazide; Glycemic control; Treatment adherence; Type 2 diabetes