Safety, tolerability, and efficacy of metformin extended-release oral antidiabetic therapy in patients with type 2 diabetes: an observational trial in Asia.

BACKGROUND: The aim of the present prospective observational study was to assess the tolerability and antihyperglycemic efficacy of metformin extended-release (MXR) in the routine treatment of patients with type 2 diabetes mellitus (T2DM) from six Asian countries. METHODS: Data from 3556 patients treated with once-daily MXR for 12 weeks, or until discontinuation, were analyzed. RESULTS: Treatment with MXR was well tolerated, with 97.4% of patients completing 12 weeks of treatment. Only 3.3% of patients experienced one or more gastrointestinal (GI) side-effects and only 0.7% of patients discontinued for this reason (primary endpoint). The incidence of GI side-effects and related discontinuations appeared to be considerably lower during short-term MXR therapy than during previous treatment (mean 2.71 years' duration), most commonly with immediate-release metformin. A 12-week course of MXR therapy also reduced HbA1c and fasting glucose levels from baseline. CONCLUSIONS: The present study provides new insights into the incidence of GI side-effects with MXR in Asian patients with T2DM and on the tolerability of MXR in non-Caucasian populations. Specifically, these data indicate that once-daily MXR not only improves measures of glycemic control in Asian patients with T2DM, but also has a favorable GI tolerability profile that may help promote enhanced adherence to oral antidiabetic therapy.

First insulinization with basal insulin in patients with Type 2 diabetes in a real-world setting in Asia.

BACKGROUND: The First Basal Insulin Evaluation (FINE) Asia study is a multinational, prospective, observational study of insulin-naïve Type 2 diabetes mellitus (T2DM) patients in Asia, uncontrolled (A1c ≥ 8%) on oral hypoglycemic agents, designed to evaluate the impact of basal insulin initiation. METHODS: Basal insulin was initiated with or without concomitant oral therapy and doses were adjusted individually. All treatment choices, including the decision to initiate insulin, were at the physician's discretion to reflect real-life practice. RESULTS: Patients (n=2679) from 11 Asian countries were enrolled (mean [±SD] duration of diabetes 9.3±6.5 years; weight 68.1±12.7 kg; A1c 9.8 ± 1.6%). After 6 months of basal insulin (NPH insulin, insulin glargine, or insulin detemir), A1c decreased to 7.7±1.4%; 33.7% patients reached A1c <7%. Fasting blood glucose (FBG) decreased from 11.7±3.6 to 7.2±2.5 mmol/L and 36.8% of patients reached FBG <6.1 mmol/L. The mean daily insulin dose prescribed increased marginally from 0.18 to 0.23 U/kg per day at baseline to 0.22-0.24 U/kg per day at Month 6. Mean changes in body weight and reported rates of hypoglycemia were low over the duration of the study. CONCLUSIONS: Initiation of insulin therapy is still being delayed by approximately 9 years, resulting in many Asian patients developing severe hyperglycemia. Initiating insulin treatment with basal insulin was effective and safe in Asian T2DM patients in a real-world setting, but insulin needs may differ from those in Western countries.