中华内科杂志
中華內科雜誌
중화내과잡지
Chinese Journal of Internal Medicine
2015年
11期
949-953
,共5页
潘长玉%李文慧%曾姣娥%李成江%杨金奎%姬秋和%陆菊明%吕肖峰%李雪锋
潘長玉%李文慧%曾姣娥%李成江%楊金奎%姬鞦和%陸菊明%呂肖峰%李雪鋒
반장옥%리문혜%증교아%리성강%양금규%희추화%륙국명%려초봉%리설봉
糖尿病,2型%阿格列汀%临床试验,Ⅲ期
糖尿病,2型%阿格列汀%臨床試驗,Ⅲ期
당뇨병,2형%아격렬정%림상시험,Ⅲ기
Diabetes mellitus,type 2%Alogliptin%Clinical trials,phase Ⅲ
目的 评价阿格列汀在中国大陆人群中治疗2型糖尿病的有效性和安全性.方法 多中心、随机、双盲、安慰剂对照的Ⅲ期临床研究,入组491例2型糖尿病患者,1:1随机接受阿格列汀(25 mg,每天1次)或相应安慰剂进行为期16周的治疗,其中单药治疗组(A组)181例,联合二甲双胍组(B组)186例,联合吡格列酮组(C组)124例.结果 第16周时,A、B、C3组中阿格列汀和安慰剂分别使糖化血红蛋白(HbA1c)降低1.00％和0.43％,0.91％和0.23％,0.76％和0.25％(P值均＜0.001).与安慰剂相比,阿格列汀可显著降低空腹血糖(FPG),并提高患者HbA1c≤6.5％和≤7.0％的达标比例.阿格列汀与安慰剂的全部不良反应,包括低血糖发生率差异均无统计学意义.结论 在中国大陆2型糖尿病患者中,与安慰剂相比,无论单药或联用二甲双胍或联用吡格列酮,阿格列汀均可显著降低HbA1c与FPG,提高HbA1c达标率.同时,阿格列汀与安慰剂的低血糖发生率和总体安全性类似.
目的 評價阿格列汀在中國大陸人群中治療2型糖尿病的有效性和安全性.方法 多中心、隨機、雙盲、安慰劑對照的Ⅲ期臨床研究,入組491例2型糖尿病患者,1:1隨機接受阿格列汀(25 mg,每天1次)或相應安慰劑進行為期16週的治療,其中單藥治療組(A組)181例,聯閤二甲雙胍組(B組)186例,聯閤吡格列酮組(C組)124例.結果 第16週時,A、B、C3組中阿格列汀和安慰劑分彆使糖化血紅蛋白(HbA1c)降低1.00％和0.43％,0.91％和0.23％,0.76％和0.25％(P值均＜0.001).與安慰劑相比,阿格列汀可顯著降低空腹血糖(FPG),併提高患者HbA1c≤6.5％和≤7.0％的達標比例.阿格列汀與安慰劑的全部不良反應,包括低血糖髮生率差異均無統計學意義.結論 在中國大陸2型糖尿病患者中,與安慰劑相比,無論單藥或聯用二甲雙胍或聯用吡格列酮,阿格列汀均可顯著降低HbA1c與FPG,提高HbA1c達標率.同時,阿格列汀與安慰劑的低血糖髮生率和總體安全性類似.
목적 평개아격렬정재중국대륙인군중치료2형당뇨병적유효성화안전성.방법 다중심、수궤、쌍맹、안위제대조적Ⅲ기림상연구,입조491례2형당뇨병환자,1:1수궤접수아격렬정(25 mg,매천1차)혹상응안위제진행위기16주적치료,기중단약치료조(A조)181례,연합이갑쌍고조(B조)186례,연합필격렬동조(C조)124례.결과 제16주시,A、B、C3조중아격렬정화안위제분별사당화혈홍단백(HbA1c)강저1.00％화0.43％,0.91％화0.23％,0.76％화0.25％(P치균＜0.001).여안위제상비,아격렬정가현저강저공복혈당(FPG),병제고환자HbA1c≤6.5％화≤7.0％적체표비례.아격렬정여안위제적전부불량반응,포괄저혈당발생솔차이균무통계학의의.결론 재중국대륙2형당뇨병환자중,여안위제상비,무론단약혹련용이갑쌍고혹련용필격렬동,아격렬정균가현저강저HbA1c여FPG,제고HbA1c체표솔.동시,아격렬정여안위제적저혈당발생솔화총체안전성유사.
Objective To evaluate the efficacy and safety of alogliptin in Chinese patients with type 2 diabetes (T2DM).Methods This was a multicenter, randomized, double-blind, placebo-controlled phase Ⅲ trial.A total of 491 subjects with T2DM were randomized in a 1:1 ratio to receive alogliptin (25 mg once daily) or placebo for 16 weeks.Among them, 181 were in the monotherapy group (group A), 186 were in the add-on to metformin group (group B), and 124 were in the add-on to pioglitazone group (group C).Results After 16 weeks of therapy, glycosylated hemoglobin A1c (HbA1c) levels decreased in both alogliptin and placebo groups.The mean changes in HbA1c for alogliptin and placebo were 1.00％and0.43％ (P＜0.001), 0.91％ and0.23％ (P＜0.001), and0.76％ and0.25％ (P＜0.001) in group A, B and C, respectively.Compared with placebo, alogliptin treatment led to a greater decrease in fasting plasma glucose (FPG) and a higher percentage of subjects who achieved HbA1 c targets of ≤ 6.5％ and ≤ 7.0％.The percentage of subjects who experienced all adverse events including hypoglycemia with alogliptin were comparable to those with placebo.Conclusions Alogliptin 25 mg once daily reduced HbA1 c and FPG, and increased a greater proportion of subjects achieving HbA1c goals of ≤6.5％ and ≤7.0％ compared with placebo when used as a monotherapy, add-on to metformin, or add-on to pioglitazone.The hypoglycemia rates and safety profiles with alogliptin were similar to those with placebo.
