Efficacy and safety of Sancailianmei Particle compared with acarbose in patients with type 2 diabetes mellitus inadequately controlled with metformin

Objective: To compare the efficacy and safety of Sancailianmei Particle (SLP) and Acarbose in type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin. Methods: A randomized, parallel group, multi-center clinical trial was conducted. 100 cases of T2DM patients inadequately controlled with metformin were included and randomly divided into Sancai group and Acarbose group. 50 cases of Sancai group were treated with SLP combined with Metformin. Another 50 cases of Acarbose group were treated with Acarbose combined with Metformin. The efficacy was evaluated by comparing fasting blood-glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin, blood lipid, weight, body mass index, insulin resistance and its related indicators. The safety was assessed by observing routine blood test, liver and kidney function test, electrocardiogram and incidence of adverse reaction. Results: HbA1C, fasting and postprandial glucose of both groups were effectively reduced (P<0.01), with no significant difference (P>0.05) between the two groups. Total cholesterol (TC) and low density lipoprotein (LDL-C) in Sancai group was significantly decreased (P<0.05), while they were not significantly decreased in Acarbose group (P>0.05). Blood glucose level was effectively reduced in both groups (P<0.05). The 1hINS and 2hINS were significantly increased, but 3hINS was significantly decreased in Sancai group (P<0.05). There was significant improvement of beta cell function index in Sancai group (P<0.05). The incidence of gastrointestinal adverse reactions and diarrhea in Sancai group was lower than Acarbose group. Conclusion: SLP has advantages of decreasing blood lipid and improving the function of islet beta cells with satisfying safety and tolerance.