Abstract: AIM: To evaluate the efficacy and safety of domestic mitiglinide and imported nateglinide. METHODS: The study was designed in double blind and double simulation fashion.218 patients of type 2 DM were randomly treated with either mitiglinide or nateglinide.The treatment course was 16 weeks.Before the treatment and after 16 weeks of the treatment, the blood glucose of 2 hours after meal, HbA1C, fasting plasma glucose in vein and FBG were detected as the efficient index.The adverse event, adverse reaction incident, blood pressure, heart rate, blood and urine routine, function of Liver and Kindey, ECG were detected as the safety index.RESULTS: Blood glucose of 2 hours after meal, HbA1C, fasting plasma glucose in vein and FBG were decreased in both groups after treatment, efficacy, adverse event, adverse reaction incident, blood press, heart rate, blood and urine routine, function of Liver and Kindey, ECG were no distinct difference between mitiglinide and nateglinide P 0.05.CONCLUSION: The curative effect of domestic mitiglinide is exact, efficacy and the tolerance is favourable.

Key words: diabetes mellitus, mitiglinide, efficacy, security