Chan Juliana C N, Aschner Pablo, Owens David R, Picard Sylvie, Vincent Maya, Dain Marie-Paule, Pilorget Valerie, Loizeau Virginie, Echtay Akram, Fonseca Vivian
Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, China.
Pontificia Universidad Javeriana, Hospital Universitario San Ignacio, Bogotá, Colombia.
J Diabetes Complications. 2015 Jan-Feb;29(1):134-41. doi: 10.1016/j.jdiacomp.2014.08.007. Epub 2014 Aug 27.
We examined the effects of adding glargine to metformin-sitagliptin (MS+G) or sitagliptin to metformin-glargine (MG+S) therapy in type 2 diabetic persons uncontrolled after 24-week MS or MG dual therapy.
Subjects with A1c≥7% on MS or MG treatment were respectively given glargine (0.2U/kg starting dose) or sitagliptin (100mg daily) for 12weeks. The primary endpoint was number of subjects attaining A1c goal defined as <7%.
After receiving 24-week MS or MG dual therapy in the original EASIE Study, 42% (104/248) on MS and 68% (152/224) on MG attained A1c<7% (p<0.0001). The reduction in A1c was negatively associated with baseline fasting blood glucose (FBG) only in the MG group. Reduction in A1c was not related to baseline postprandial blood glucose (PPBG) in either the MG or MS group. Amongst 194 eligible patients, 57.7% (n=111) entered the 12-week extension trial [MS+G:74/131, 57.3%; MG+S:37/63, 58.7%) with 55 (51.9%) subjects attaining goal [MS+G:59.2%; MG+S:37.1%] at week 12. The final insulin dosage was similar in both groups [MS+G: 0.46U/kg; MG+S: 0.45U/kg] with a higher rate of hypoglycemia in the MG+S (6.5 events/patient-year) than the MS+G group (3.2 events/patient-year), although neither group had severe hypoglycemia.
In metformin-treated type 2 diabetes patients, high fasting BG predicted greater A1c reductions with the addition of glargine, but not with sitagliptin. In subjects uncontrolled with 6-month dual therapy of MS or MG, 50% attained A1c<7% with triple therapy of MS+G or MG+S in 12weeks. The increased rate of hypoglycemia with MG+S (but not with MS+G) underlines the need to take measures to avoid the hypoglycemia.
我们研究了在接受24周二甲双胍-西他列汀（MS）或二甲双胍-甘精胰岛素（MG）双联治疗后血糖仍未得到控制的2型糖尿病患者中，加用甘精胰岛素至二甲双胍-西他列汀（MS+G）治疗方案或加用西他列汀至二甲双胍-甘精胰岛素（MG+S）治疗方案的效果。
接受MS或MG治疗且糖化血红蛋白（A1c）≥7%的受试者分别接受甘精胰岛素（起始剂量0.2U/kg）或西他列汀（每日100mg）治疗12周。主要终点是达到A1c目标（定义为<7%）的受试者数量。
在最初的EASIE研究中接受24周MS或MG双联治疗后，MS组中42%（104/248）的患者和MG组中68%（152/224）的患者A1c<7%（p<0.0001）。仅在MG组中，A1c的降低与基线空腹血糖（FBG）呈负相关。在MG组和MS组中，A1c的降低均与基线餐后血糖（PPBG）无关。在194名符合条件的患者中，57.7%（n=111）进入了为期12周的延长期试验[MS+G组：74/131，57.3%；MG+S组：37/63，58.7%]，12周时55名（51.9%）受试者达到目标[MS+G组：59.2%；MG+S组：37.1%]。两组最终的胰岛素剂量相似[MS+G组：0.46U/kg；MG+S组：0.45U/kg]，MG+S组的低血糖发生率（6.5次事件/患者年）高于MS+G组（3.2次事件/患者年），尽管两组均无严重低血糖事件。
在接受二甲双胍治疗的2型糖尿病患者中，高空腹血糖预示着加用甘精胰岛素时A1c降低幅度更大，但加用西他列汀时并非如此。在接受MS或MG 6个月双联治疗后血糖未得到控制的受试者中，50%的患者在12周内通过MS+G或MG+S三联治疗使A1c<7%。MG+S组（而非MS+G组）低血糖发生率增加强调了采取措施避免低血糖的必要性。
