Implementing an optimized glucose-lowering strategy with a novel once daily modified release gliclazide formulation. (February 2016)

• Record Type: Journal Article
• Authors: Leiter, Lawrence A.; Shestakova, Marina V.; Trubitsyna, Natalya P.; Piletič, Milivoj; Satman, Ilhan
• Is Part Of: Diabetes research and clinical practice. Volume 112(2016)
• Page Start: 50
• Page End: 56
• Publication Date: 2016-02
• Subjects: Type 2 diabetes -- Gliclazide -- Glycemic control -- Treatment adherence; Diabetes -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462
• DOI: 10.1016/j.diabres.2015.11.001
• Languages: English
• ISSNs: 0168-8227

Abstract

Highlights: A new scored gliclazide modified release formulation (MR 60 mg) was tested. The population was 7170 individuals with T2DM followed for 6 months. Study arms were first-line; add-on; switch from prior oral glucose lowering therapy. Mean HbA1c decreased 1.6–2.0%; 65% of patients achieved HbA1c ≤7.0% (53 mmol/mol). There was modest weight loss and 0.06% of participants reported hypoglycemic events. Abstract: Aim: 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.