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MARCH2:阿卡波糖与二甲双胍对新诊断2型糖尿病患者治疗效果的比较评估

MARCH2: comparative assessment of therapeutic effects of acarbose and metformin in newly diagnosed type 2 diabetes patients.

作者信息

Wang Guang, Liu Jia, Yang Ning, Gao Xia, Fan Hui, Xu Yuan, Yang Wenying

机构信息

Department of Endocrinology, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, P. R. China.

Department of Endocrinology, China-Japan Friendship Hospital, Beijing, P. R. China.

出版信息

PLoS One. 2014 Aug 22;9(8):e105698. doi: 10.1371/journal.pone.0105698. eCollection 2014.

Abstract

BACKGROUND

The data of MARCH (Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment) trial demonstrated that acarbose and metformin have similar efficacy as initial therapy for hemoglobin A1c (HbA1c) reduction in Chinese patients with newly diagnosed type 2 diabetes. We investigated whether the therapeutic efficacy was diversified under different body mass index (BMI) status.

METHODS

All 784 subjects were divided into normal-weight group (BMI<24 kg/m2), overweight group (BMI 24-28 kg/m2) and obese group (BMI≥28 kg/m2). Patients were assigned to 48 weeks of therapy with acarbose or metformin, respectively. The clinical trial registry number was ChiCTR-TRC-08000231.

RESULTS

The reduction of HbA1c levels and the proportion of patients with HbA1c of 6.5% or less were similar in the three groups after acarbose and metformin treatment. In overweight group, fasting blood glucose (FBG) after metformin treatment showed greater decline compared to acarbose group at 48 weeks [-1.73 (-1.99 to -1.46) vs. -1.37 (-1.61 to -1.12), P<0.05), however the decrease of 2 h post-challenge blood glucose (PBG) after acarbose treatment at 48 weeks was bigger compared to metformin group [-3.34 (-3.83 to-2.84) vs. -2.35 (-2.85 to -1.85), P<0.01]. Both acarbose and metformin treatment resulted in a significant decrease in waist circumference, hip circumference, weight and BMI in the three groups (all P<0.05).

CONCLUSION

Acarbose and metformin decreased HbA1c levels similarly regardless of BMI status of Chinese type 2 diabetic patients. Acarbose and metformin resulted in a significant and modest improvement of anthropometric parametres in different BMI status. Thus, acarbose treatment may contribute a similar effect on plasma glucose control compared to metformin, even in obesity patients.

TRIAL REGISTRATION

ChiCTR.org ChiCTR-TRC-08000231.

摘要

背景

MARCH(二甲双胍和阿卡波糖作为初始降糖治疗)试验数据表明,在中国新诊断的2型糖尿病患者中,阿卡波糖和二甲双胍作为降低糖化血红蛋白(HbA1c)的初始治疗药物,疗效相似。我们研究了在不同体重指数(BMI)状态下,治疗效果是否存在差异。

方法

将784名受试者分为正常体重组(BMI<24 kg/m²)、超重组(BMI 24-28 kg/m²)和肥胖组(BMI≥28 kg/m²)。患者分别接受48周的阿卡波糖或二甲双胍治疗。临床试验注册号为ChiCTR-TRC-08000231。

结果

阿卡波糖和二甲双胍治疗后,三组患者的HbA1c水平降低幅度以及HbA1c≤6.5%的患者比例相似。在超重组中,48周时二甲双胍治疗后的空腹血糖(FBG)下降幅度大于阿卡波糖组[-1.73(-1.99至-1.46)vs.-1.37(-1.61至-1.12),P<0.05],然而48周时阿卡波糖治疗后的餐后2小时血糖(PBG)下降幅度大于二甲双胍组[-3.34(-3.83至-2.84)vs.-2.35(-2.85至-1.85),P<0.01]。阿卡波糖和二甲双胍治疗均使三组患者的腰围、臀围、体重和BMI显著下降(均P<0.05)。

结论

无论中国2型糖尿病患者的BMI状态如何,阿卡波糖和二甲双胍降低HbA1c水平的效果相似。阿卡波糖和二甲双胍在不同BMI状态下均能显著且适度地改善人体测量参数。因此,即使在肥胖患者中,阿卡波糖治疗在血糖控制方面可能与二甲双胍有相似的效果。

试验注册

中国临床试验注册中心ChiCTR-TRC-08000231。

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