Cardiovascular Research Unit, Physiology Department, Health Science University Center, University of Guadalajara, Guadalajara, Mexico.
Diabetes Technol Ther. 2012 Dec;14(12):1140-4. doi: 10.1089/dia.2012.0097. Epub 2012 Sep 13.
This study evaluated the effect of metformin glycinate on glycated hemoglobin A1c (A1C) concentration and insulin sensitivity in drug-naive adult patients with type 2 diabetes mellitus (T2DM).
A randomized, double-blind, placebo-controlled clinical trial was carried out in 20 patients with drug-naive T2DM. Ten subjects received metformin glycinate (1,050.6 mg) once daily during the first month and force-titrated twice daily during the second month. Ten additional patients received placebo as the control group. Before and after the intervention, metabolic profile including A1C and insulin sensitivity (euglycemic-hyperinsulinemic clamp technique) was estimated.
A1C concentrations decreased significantly with metformin glycinate administration (8.0 ± 0.7% vs. 7.1 ± 0.9%, P = 0.008) before and after the intervention, respectively. There were significant differences in changes from baseline of A1C between groups (0.0 ± 0.7% vs. -1.0 ± 0.5% for placebo and metformin glycinate groups, respectively; P = 0.004). A reduction of ≥1% in A1C levels was reached in 60.0% of patients with metformin glycinate administration (P = 0.02). Insulin sensitivity was not modified by the intervention.
Administration of metformin glycinate during a 2-month period showed a greater decrease in A1C concentrations than placebo in a selected group of drug-naive adult patients with T2DM.
本研究评估了甘氨酸二甲双胍对初治 2 型糖尿病(T2DM)成年患者糖化血红蛋白 A1c(A1C)浓度和胰岛素敏感性的影响。
在 20 例初治 T2DM 患者中进行了一项随机、双盲、安慰剂对照的临床试验。10 例患者在第一个月接受甘氨酸二甲双胍(1050.6mg)每日 1 次治疗,第二个月改为每日 2 次强制滴定。另外 10 例患者接受安慰剂作为对照组。干预前后,评估了包括 A1C 和胰岛素敏感性(正葡萄糖高胰岛素钳夹技术)在内的代谢谱。
甘氨酸二甲双胍治疗后 A1C 浓度显著降低(8.0±0.7%比7.1±0.9%,P=0.008)。两组间 A1C 从基线的变化有显著差异(安慰剂组和甘氨酸二甲双胍组分别为 0.0±0.7%比-1.0±0.5%,P=0.004)。甘氨酸二甲双胍治疗组有 60.0%的患者 A1C 水平降低≥1%(P=0.02)。胰岛素敏感性不受干预影响。
在 2 个月的治疗期间,甘氨酸二甲双胍组 A1C 浓度的降低大于安慰剂组,在一组选定的初治成年 T2DM 患者中。