| BackgroudIn the course of type 2 diabetes mellitus, the insulin sensitivity and beta cell function decrease progressively, resulting in insulin lackage and hyperglycemia. It was already confirmed that patients with type 2 diabetes suffer high glucagon levels and postprandial GLP-1 response deficiency. GLP-1 as an important incretin, may has an effect to control hyperglycemia quickly and effectively, suppress glucagon secretion, improve beta-cell function and delay diabetes progression. However, the short half-life of natural GLP-1 limits clinical applications. The researchers are making great efforts to prolong the acting time of GLP-1.ObjectiveTo evaluate the efficacy and safety of recombinant human glucagon-like peptide-1 [rhGLP-1(7-36)] administered subcutaneously before meals in combination with oral metformin in patients with type 2 diabetes mellitus.MethodsIn this randomized, placebo-controlled study.42 patients with type 2 diabetes were randomly assigned to two groups. They received rhGLP-1(7-36) 0.2mg (The study group, n=21) or placebo (The control group, n=21) subcutaneously in addition to original dose of metformin and then followed for 12 weeks. Several biomedical parameters were recorded before and after the treatment, including HbAlc, weight. heart rate, blood pressure, blood fat. ALT. AST. SCr. UA. plasma level of glucose and insulin. Adverse reactions were also observed. The efficacy and safety indicators of the rhGLP-1(7-36) group were assessed compared with placebo group. Statistical procedures were performed with the statistical package PASW 18.0. Significance is defined as a two tailed P＜0.05.ResultNo significant difference was found in the basic data of the two groups (P>0.05), so they were comparable.①The level of H bA lc, fasting and postprandial blood glucose were lowered more in rhGLP-1+Met group than control (P<0.05).②The increase ofΔI20/ΔG20 was more significantly in rhGLP-1+Met group than control (P＜0.05).③BMI dropped significantly in two groups (P<0.01或P<0.05), but the two have no statistical difference. The decrease of BMI in rhGLP-1+Met group was positively correlated with the baseline.④After rhGLP-1+Met treatment, ALT, AST declined more significantly compared with control group (P<0.05).⑤There was no definitive hypoglycemia happen in both groups. The most common adverse reactions reported were gastrointestinal symptoms which were usually mild to moderate and spontaneous remission with time. The incidence did not differ significantly between two groups.http://dict.youdao.com/search?q=%E6%9C%80%E5%B8%B8%E8%A7%81%E7%9A% 84%E4%B8%8D%E8%89%AF%E5%8F%8D%E5%BA%94&ue=utf8&keyfrom=dict.indexConclusionSubcutaneously injection of rhGLP-1(7-36) in combination with oral metformin is effective in lowering FPG, PPG and promoting early-phase insulin secretion while decreasing BMI in a baseline-dependent mode. Furthermore, the treatment does not increase the risk of hypoglycemia and other adverse events. |
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