艾塞那肽对口服降糖药治疗欠佳的肥胖2型糖尿病患者的疗效及安全性

目的 评估艾塞那肽与双时相门冬胰岛素30在口服降糖药控制不佳的肥胖2型糖尿病患者中的疗效及安全性.方法 选取2010年2月至8月就诊的2型糖尿病患者,年龄＞35岁,体质指数(BMI)＞25 kg/m2,腰围男＞90cm,女＞85 cm,糖化血红蛋白(HbA1c)为7.5%～10.5%,二甲双胍与磺脲类降糖药治疗达12个...

Efficacy and safety of exenatide versus insulin in patients with inadequately glycemic controlled obese type 2 diabetes with oral antidiabetic agents

Objective To investigate the efficacy and safety of exenatide versus biphasic insulin aspart 36(BIAsp30) in patients with inadequately glycemic controlled and obese type 2 diabetes with oral antidiabetes agents.Methods A single center, randomized, open-label, parallel-group study was conducted.Four weeks run-in period and 16 weeks treatment period were included.Eighty subjects were enrolled( ( ＞35 years old, BMI ＞ 25 kg/m2 ), waist circumference( male ＞ 90 cm and female ＞ 85 cm),HbA1c 7.5%-10.5% ).All subjects which received metformin (at least 1000 mg/d) or sulfonylurea (at least half the maximal dose) for at least 12 months were randomly assigned to exenatide group( n =40) or BIAsp30 group ( n = 40) twice or thrice daily.The t and X2 test was used in the data analysis.Results Compared to the baseline, the HbAlc values decreased in exenatide group(7.6% ±0.9% )and in BIAsp30 group(7.2% ± 1.0% ) after 16 weeks treatment ( t = - 3.6, P ＜ 0.01 ).The proportion of patients which HbA1c less than 6.5% was 37.8% ( BIAsp30 group) and 16.7% ( exenatide group, X2 =4.1, P ＜0.05 ).The proportion of patients which HbA1 c less than 7.0% was 47.2% and 54.1 %, respectively ( X2 = 0.3,P ＞ 0.05 ).Weight gain was observed for the BIAsp30 group (2.7 ± 1.4) kg while weight loss was reported for the exenatide group (3.4 ± 1.7 ) kg.The amount of subjects reporting hypoglycemic events was significantly greater in BIAsp30 group than in exenatide group (4.88 vs 1.95 events/subject per year).The reductions of systolic blood pressure ,and the improvement of lipid profile in exenatide group were superior to that of BIAsp30 group.However, There was no significant difference on diastolic blood pressure and homocysteic acid between the two groups ( P ＞ 0.05 ).Conclusions Eexenatide is superior on reduction of hypoglycemic events, control weight, and improvement of lipid parameters to BIAsp30.