Tóm tắt

Background: Type 2 diabetes mellitus (T2DM) is rapidly emerging as a major cause of morbidity and mortality in Vietnam. In view of local treatment guidelines recommending the addition of insulin glargine 100 U/ml (Gla-100) to people uncontrolled onoral anti-diabetic drugs (OADs), real-world data on effectiveness and safety of this basal insulin are lacking. Methods: A 6-month prospective, observational, multicenter, real-world studywas conducted between May 2015 and January 2017 in Vietnam, includinginsulin-naïve people with T2DM having glycated hemoglobin [HbA1c] between 7.5%–10%, and to whom Gla-100 was prescribed.Change in HbA1c and fasting blood glucose (FBG), Gla-100 dose, percentage of participants achieving HbA1c<7.0%, and demographic characteristics, treatment satisfaction (measured using Diabetes Treatment Satisfaction Questionnaire [DTSQ]), and adverse events (AEs) from baseline to six months were evaluated. Results: Overall, 343 people were documented. Mean HbA1c decreased from 8.6±0.8% to 8.0±1.2% (p<0.001) and mean FBG decreased from 9.8±2.7 to 8.4±2.6 mmol/L(p<0.0001) from baseline tosix months. At 3 and 6 month, 14.0% and 19.2%of participants achieved HbA1c<7.0%, respectively. Mean daily dose of Gla-100 increased from 10.5±4.8 at baseline to 13.7±5.8U/day at six months p <0.0001). Baseline HbA1c and presence of diabetes complications were predictors for target HbA1c achievement. All parameters of DTSQ improved at six months. The incidence of severe hypoglycemia was low, with no weight gain and no new/unexpected AEs. Conclusions: In Vietnamese people with T2DM uncontrolled on OADs, addition of Gla-100 significantly improved glycemic control and was well tolerated. However, dose titration was suboptimal. More active dose titration of Gla-100 might further improve glycaemic outcome in patients in real-world daily practice.