ABSTRACT
AIM: To investigate the efficacy and safety of repaglinide alone and in combination with metformin therapy. METHODS: Seventy-two type 2 diabetes patients who were oral anti-diabetic drugs (OAD)-naive or currently on OAD for </=36 months with HbA1c </=9% and fasting plasma glucose (FPG) pound 13 mmol/L were recruited. Patients were titrated for 6 weeks to a dose level which maintained fasting blood glucose at 4.4-7.0 mmol/L and continued treatment for 8 weeks. Dose regimen started with 0.5 mg repaglinide each main meal, progressing to 1.0 mg repaglinide, 1.0 mg repaglinide + metformin 500 mg b.i.d. and 1.0 mg repaglinide + metformin 500 mg t.i.d., depending on patients' glycaemic status. Patients' glycaemic control (HbA(1c) and FPG), body weight and other safety parameters were evaluated. RESULTS: Thirty-seven patients completed the trial. Patients were overweight (mean BMI 25.5 +/- 4.1 kg/m(2)) with mean age 52.5 +/- 8.8 years and mean diabetes duration of 2.4 +/- 3.8 years. Mean HbA1c (2.26 +/- 0.22%, [p <0.05]) and FPG (3.31 +/- 0.47 mmol/L, [p <0.05]) decreased significantly from baseline. Body weight did not change significantly (0.85 +/-0.45 kg, p=0.068). Of the 33 patients who had baseline FPG >7.0 mmol/L, it appeared that repaglinide alone at doses 0.5 or 1.0 mg achieved FBG <7.0 mmol/L in 67% of patients. The majority of the treatment emergent adverse events were mild and unlikely related to trial product. Episodes of symptomatic hypoglycaemia were low (9.3%) in frequency. The changes in haematology, clinical biochemistry and urinalysis were mostly minor or remained unchanged. Vital signs and the results of physical examination also remained unchanged. Three of the four withdrawals were due to adverse events but were unlikely related to trial product. CONCLUSION: treatment with repaglinide alone and in combination with metformin was efficacious in glycaemic control in OAD-naive or previous users. Most of the patients appeared to achieve good control with repaglinide alone. The treatment regimens were safe (317 words).