Ensor Mark, Williams Jarrod, Smith Rebecca, Banfield Amy, Lodder Robert A
Department of Pharmaceutical Sciences, College of Pharmacy, University of Kentucky, USA.
J Endocrinol Diabetes Obes. 2014 Oct;2(4):1057.
The primary objective of this study was to evaluate the safety and the effect of D-tagatose on the glycemic control of subjects with type 2 diabetes as determined by HbA levels at the end of 6 months of therapy using the subject's own baseline HbA level as a comparator. The determination of the minimal dose required to cause a statistically significant reduction in HbA was of particular interest. Eight weeks after screening, the qualifying subjects were randomized to receive one of three doses of D-tagatose: 2.5 g TID, 5.0 g TID or 7.5 g TID. Blood levels of HbA, fasting blood glucose concentrations, plasma lipids, changes in body weight, changes in body mass index, and change in insulin levels were checked at each study visit and at the end of the study. Treatment success, as measured by the reduction of HbA, was greatest for the 7.5 g D-tagatose dose group, although the difference between the treatments was not statistically significant. For fasting glucose, only the 7.5 g dosage group exhibited reductions from baseline at the 3- and 6-month time points. Mean body weights reduced in a dose-response fashion, with the 5.0 g and the 7.5 g D-tagatose doses providing the greatest reductions. D-tagatose at dosages of 2.5 g, 5.0 g, and 7.5 g TID for six months were well tolerated by this subject population. D-tagatose at 5.0 g TID was the minimal dose required to reduce HbA. D-tagatose at 7.5 g TID provided the greatest effect in most measured efficacy parameters.
本研究的主要目的是评估D-塔格糖对2型糖尿病患者血糖控制的安全性和效果，以治疗6个月结束时的糖化血红蛋白（HbA）水平作为衡量指标，并将患者自身的基线HbA水平作为对照。确定能使HbA产生具有统计学意义降低的最小剂量尤其令人关注。筛选8周后，符合条件的受试者被随机分为三组，分别接受三种剂量的D-塔格糖：每日三次，每次2.5克；每日三次，每次5.0克；或每日三次，每次7.5克。在每次研究访视时以及研究结束时，检测HbA的血液水平、空腹血糖浓度、血脂、体重变化、体重指数变化以及胰岛素水平变化。以HbA降低幅度衡量的治疗成功率在7.5克D-塔格糖剂量组中最高，尽管各治疗组之间的差异无统计学意义。对于空腹血糖，只有7.5克剂量组在3个月和6个月时间点出现了相对于基线水平的降低。平均体重呈剂量反应性降低，5.0克和7.5克D-塔格糖剂量组的体重降低幅度最大。该受试者群体对每日三次，每次2.5克、5.0克和7.5克，持续6个月的D-塔格糖耐受性良好。每日三次，每次5.0克的D-塔格糖是降低HbA所需的最小剂量。每日三次，每次7.5克的D-塔格糖在大多数测量的疗效参数方面效果最佳。
