沙格列汀或吡格列酮联合二甲双胍治疗初诊2型糖尿病临床观察

摘 要 目的： 探讨单用二甲双胍血糖未达标的初诊2型糖尿病加用沙格列汀或吡格列酮治疗的疗效及安全性。方法: 82例单用二甲双胍治疗12周血糖未达标的初诊2型糖尿病患者随机分为两组,分别联合沙格列汀或吡格列酮治疗12周,观察两组患者治疗前后血糖控制情况、胰岛素抵抗指数（HOMA-IR）、体质指数（BMI）变化及两组不良反应的差别。结果: 联合治疗12周后,两组空腹血糖(FPG)、餐后2 h血糖(2hPG)和糖化血红蛋白(HbA1c)均较治疗前明显降低（P<0.05）,沙格列汀组2hPG及HbAlc下降幅度优于吡格列酮组（P<0.05）,但FPG下降幅度小于吡格列酮组（P<0.05）。吡格列酮组空腹胰岛素水平下降及HOMA-IR的改善优于沙格列汀组（P<0.05）,沙格列汀组治疗后BMI无改变（P>0.05）,吡格列酮组治疗后BMI增加（P<0.05）;两组患者药品不良反应比较,差异无统计学意义（P>0.05）。结论:单用二甲双胍血糖控制不佳的初诊2型糖尿病患者加用沙格列汀或吡格列酮均能有效控制血糖,改善胰岛素抵抗,沙格列汀更适合于合并器质性心脏病或老年患者。     

吡格列酮联合二甲双胍治疗2型糖尿病疗效观察

目的观察吡格列酮联合二甲双胍治疗2型糖尿病的临床疗效。方法152例2型糖尿病患者按数字表法随机分为对照组和治疗组各76例,对照组口服二甲双胍0．5g,3次／d;治疗组给予吡格列酮30mg,1次／d,同时口服二甲双胍0．5g,3次／d。两组连续治疗3个月。结果治疗组治疗总有效率96．1％明显高于对照组的84．2％（P〈0．05）;两组治疗后空腹血糖和餐后血糖均明显低于治疗前（均P〈0．05）,治疗组较对照组降低更明显（均P〈0．05）;两组均未发生严重不良反应。结论吡格列酮联合二甲双胍治疗2型糖尿病临床效果显著,优于单用二甲双胍治疗。     

二甲双胍联合吡格列酮治疗2型糖尿病疗效观察

目的 探讨二甲双胍联合吡格列酮治疗2型糖尿病临床效果及安全性.方法 选取我院2009年1月至2011年10月收治2型糖尿病患者227例,随机分为两组,其中对照组114例,采用二甲双胍口服治疗,0.5 g/次,每天3次;实验组113例,在对照组治疗基础上,加用吡格列酮片口服治疗,20mg/次,1次/d;疗程均为6个月;比较两组患者治疗前后FPG、P2 hBG及HbA1c等血糖指标,FINS、P2 hINS 及HOMA- IR指数等胰岛素指标,BMI指数以及不良反应发生率等.结果 对照组与实验组患者治疗前FPG、P2hBG及HbA1c等血糖指标,FINS、P2 hINS及HOMA- IR指数等胰岛素指标组间比较组间差异无统计学意义(P＞0.05);两组患者治疗后各项血糖指标及胰岛素指标较治疗前均显著改善,组间比较差异有统计学意义(P＜0.05);同时实验组患者各项血糖指标及胰岛素指标改善程度明显高于对照组,组间比较比较差异有统计学意义(P＜0.05);实验组患者治疗前后BMI指数组间比较差异无统计学意义;但对照组患者治疗后BMI指数较治疗前明显降低,组间比较差异有统计学意义(P＜0.05)同时两组患者不良反应发生率比较组间差异无统计学意义(P＞0.05).结论 二甲双胍联合吡格列酮治疗2型糖尿病临床效果确切,能够显著降低血糖水平,改善胰岛素抵抗症状,同时对体质量影响较小,不良反应少,可作为2型糖尿病治疗首选方案.     

二甲双胍联合吡格列酮治疗2型糖尿病疗效观察

目的：观察针对2型糖尿病的治疗中应用二甲双胍联合吡格列酮的临床疗效。方法：选取2013年2月～2014年2月我院收治的64例2型糖尿病患者作为研究对象,随机分为对照组与研究组各32例,给予对照组二甲双胍片药物治疗,研究组在此基础上联合使用吡格列酮加以治疗,对比分析两组的临床各项指标及疗效的变化情况。结果：结束3个月疗程的治疗后,两组患者空腹状态时的血糖水平、餐后2h血糖水平以及糖化血红蛋白水平同治疗前比较均显著降低;研究组结束3个月的治疗后各项临床指标同结束1个月的治疗后相比其水平均显著降低;研究组对血糖控制的总有效率93.75%,对照组对血糖控制的总有效率78.13%,组间对比差异显著（P＜0.05）,具有统计学意义。结论：针对2型糖尿病的治疗中应用二甲双胍联合吡格列酮获得了较为理想的临床效果,安全性较高,值得推广。     

二甲双胍联合吡格列酮治疗2型糖尿病的疗效观察

目的探讨二甲双胍联合吡格列酮治疗2型糖尿病的临床疗效。方法入选的70例2型糖尿病患者,其中35例患者应用二甲双胍联合吡格列酮治疗,设为观察组,余35例2型糖尿病患者行二甲双胍治疗,设为对照组,应用统计学方法对比分析两组治疗6个月后的疗效及比较两组患者治疗前后空腹血糖(FBG)、餐后2h血糖(PBG)及糖化血红蛋白(HbA1C)的变化情况,同时注意并记录治疗过程中发生的不良反应情况。结果观察组治疗后的总有效率达94.3%,明显高于对照组治疗后的总有效率77.1%(P0.05)。观察组与对照组患者治疗6个月后的FBG、2h PBG、HbA1C均较治疗前明显降低,且观察组患者的FBG、2h PBG、HbA1C均明显低于对照组(P0.05)。结论二甲双胍联合吡格列酮治疗可以明显改善2型糖尿病的血糖和糖化血红蛋白水平,疗效确切,值得推广和应用。     

二肽基肽酶4抑制剂联合二甲双胍治疗2型糖尿病的临床疗效

目的观察并初步探讨二肽基肽酶4(Dipeptidyl peptidase 4,DPP4)抑制剂西格列汀联合二甲双胍治疗2型糖尿病的临床疗效。方法选择2014年1月至2015年2月来我院就诊的63例2型糖尿病患者作为研究对象,随机分为3组。对照组单一给药二甲双胍(A组)、西格列汀(Sitagliptin)(B组),观察组(C组)给予西格列汀联合二甲双胍治疗,治疗12周后检测并观察各组总体疗效及相关生化指标。结果 C组治疗后空腹血糖(FBG)、餐后2小时血糖(2h BG)分别为(7.4±1.7)、(8.2±1.9)mmol/L,与A组、B组相比显著降低,差异有统计学意义(P<0.05)。C组糖化血红蛋白(Hb A1c)、体重指数(BMI)及血尿酸(UA)均较A组、B组呈下降趋势,但差异无统计学意义(P>0.05)。结论 DPP4抑制剂西格列汀联合二甲双胍治疗2型糖尿病疗效显著,能够全面控制血糖,降低体重,降低血尿酸,不增加低血糖的发生,具有良好的安全耐受性,值得临床应用推广。     

吡格列酮联用二甲双胍治疗2型糖尿病的疗效观察

目的：观察毗格列酮联用二甲双胍治疗2型糖尿病（T2DM）的疗效和安全性。方法：120例T2DM患者随机分为吡格列酮组（40例）、二甲双胍组（40例）及联合治疗组（40例）,观察治疗前后空腹血糖（FPG）及餐后2h血糖（2hPG）,糖化血红蛋白（HbAlC）及胰岛素（INS）的变化。结果：连续服吡格列酮3个月后其FPG、2h-PG、HbAlC及空腹胰岛素（FINS）与试验前比较差异均有统计学意义（P〈0．05）,与二甲双胍组比较差异也有统计学意义（P〈0．05）,对肝肾功能等无影响。结论：吡格列酮能显著降低血糖并改善胰岛素的敏感性。     

吡格列酮和二甲双胍治疗2型糖尿病的疗效观察

为观察胰岛素增敏剂治疗初发2型糖尿病(T2DM)的临床疗效,被诊断T2DDM患者90例被随机分为三组,分别给予盐酸吡格列酮、二甲双胍和二者联合治疗.结果盐酸吡格列酮和联合治疗明显降低初发T2DM的FBG、HbAlc,使体重较治疗前增加.     

吡格列酮联合二甲双胍治疗2型糖尿病59例临床疗效

目的 观察吡格列酮联合二甲双胍治疗2型糖尿病的临床疗效.方法 选择2011年1月-2012年1月该院收治2型糖尿病患者117例随机分为观察组59例与对照组58例.观察组在原饮食及运动治疗基础上加用吡格列酮片与二甲双胍片;对照组在原饮食及运动治疗基础上仅服用二甲双胍片.比较2组疗效.结果 治疗后2组患者FBG、2hBG、FINS、HbA1c均明显低于治疗前 （P〈0.05）;观察组FPG、2hPG、FINS、HbA1c较对照组改善更明显（P〈0.05）.结论 吡格列酮联合二甲双胍治疗2型糖尿病安全性有效,值得临床推广.     

吡格列酮和二甲双胍治疗2型糖尿病的疗效观察

盐酸吡格列酮（下称吡格列酮）为胰岛素增敏剂噻唑烷二酮类药物,它可以增加胰岛素敏感性（IS）,降低血糖。为观察其对2型糖尿病（T2DM）患者的临床疗效,我们对90例T2DM患者分别进行吡格列酮、二甲双胍及两者联合应用为期半年的治疗观察。现将结果报告如下：     

Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin

Abstract

Objective:

To evaluate efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes (T2D) with inadequate glycemic control on insulin alone or combined with metformin.     

二甲双胍联合西格列汀或吡格列酮对肥胖型2型糖尿病的疗效比较

目的：比较西格列汀与吡格列酮分别联用二甲双胍治疗二甲双胍单药控制不佳的肥胖型2型糖尿病的疗效。方法：60例2型糖尿病肥胖患者在服用二甲双胍片的前提下,随机分为西格列汀组（n=30）和吡格列酮组（n=30）,分别给予西格列汀片与吡格列酮片口服,检测入组时和治疗12周后两组糖化血红蛋白、空腹及餐后血糖水平、低血糖例数、体重指数等数据。结果：治疗12周后,西格列汀组患者的糖化血红蛋白、空腹及餐后血糖、体重指数均比吡格列酮组改善明显,两组均无低血糖发生。结论：西格列汀联用二甲双胍片治疗肥胖型2型糖尿病的疗效优于吡格列酮片联用二甲双胍片。     

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized,double-blind,placebo-controlled study

ABSTRACT

Objectives: To evaluate the efficacy and safety of alogliptin in patients with type 2 diabetes inadequately controlled by therapy with a thiazolidinedione (TZD).

Research design and methods: In a multicenter, double-blind, placebo-controlled clinical study, 493 patients 18–80 years old with inadequate glycemic control after stabilization (i.e., glycosylated hemoglobin [HbA_1c] 7.0–10.0%) despite ongoing treatment with a TZD were randomly assigned (2:2:1) to treatment with pioglitazone plus alogliptin 12.5?mg, alogliptin 25?mg or placebo once daily. Concomitant therapy with metformin or sulfonylurea at prestudy doses was permitted.

Main outcome measures: The primary efficacy endpoint was change in HbA_1c from baseline to Week 26. Secondary endpoints included changes in fasting plasma glucose (FPG) and body weight, and incidences of marked hyperglycemia (FPG?≥?200?mg/dL [11.10?mmol/L]) and rescue for hyperglycemia.

Results: Least squares (LS) mean change in HbA_1c was significantly (p?<?0.001) greater for alogliptin 12.5?mg (?0.66%) or 25?mg (?0.80%) than for placebo (?0.19%). A significantly (p?≤?0.016) larger proportion of patients achieved HbA_1c?≤?7% with alogliptin 12.5?mg (44.2%) or 25?mg (49.2%) than with placebo (34.0%). LS mean decreases in FPG were significantly (p?=?0.003) greater with alogliptin 12.5?mg (?19.7?mg/dL [?1.09?mmol/L]) or 25?mg (?19.9?mg/dL [?1.10?mmol/L]) than with placebo (?5.7?mg/dL [?0.32?mmol/L]). The percentage of patients with marked hyperglycemia was significantly (p?<?0.001) lower for alogliptin (≤25.0%) than placebo (44.3%). The incidences of overall adverse events and hypoglycemia were similar across treatment groups, but cardiac events occurred more often with active treatment than placebo.

Conclusions: Addition of alogliptin to pioglitazone therapy significantly improved glycemic control in patients with type 2 diabetes and was generally well tolerated. The study did not evaluate the effect of combination therapy on long-term clinical outcomes and safety.

Clinical trial registration: NCT00286494, clinicaltrials.gov.     

Glimepiride versus pioglitazone combination therapy in subjects with type 2 diabetes inadequately controlled on metformin monotherapy: results of a randomized clinical trial

ABSTRACT

Objective: To compare the effect of add-on glimepiride or pioglitazone in subjects with type 2 diabetes inadequately controlled on metformin monotherapy.

Research design and methods: Multicenter, randomized, parallel-group, open-label, forced-titration study involving 203 adults with poorly controlled type 2 diabetes (A1C 7.5–10%) on metformin monotherapy. Subjects were randomized to receive glimepiride or pioglitazone, titrated to the maximum dose for 26 weeks. Subjects were evaluated for A1C changes, fasting plasma glucose (FPG), insulin, C‐peptide, and lipid levels. Safety outcomes and diabetes-related healthcare resource utilization were also evaluated.

Results: Both treatment groups achieved similar and significant mean decreases from baseline to endpoint (week 26) in A1C (?p = 0.0001) and FPG (?p < 0.05). Glimepiride therapy, however, resulted in a more rapid decline in A1C levels at weeks 6, 12, and 20 vs. pioglitazone (?p < 0.05). A mean A1C ≤ 7% was reached faster in the glimepiride group (median, 80–90 days vs. 140–150 days [p = 0.024]). Total and LDL cholesterol were significantly higher with pioglitazone treatment than with glimepiride at endpoint (?p < 0.05). Glimepiride treatment was associated with an increased risk of hypoglycemia and pioglitazone with higher rate of peripheral edema. Healthcare resource utilization was similar between groups, but total healthcare costs were significantly lower for glimepiride versus pioglitazone over the course of the study, driven largely by drug costs. The use of fasting C‐peptide concentration ≥ 0.27?nmol/L in the inclusion criteria was a potential limitation as it may have included those patients with an improved probability for glimepiride or pioglitazone response. In addition, a larger patient population would have provided a greater degree of data applicability.

Conclusions: In patients with type 2 diabetes inadequately controlled on metformin monotherapy, add-on glimepiride or pioglitazone results in similar overall improvements in glycemic control. Compared with pioglitazone, glimepiride is associated with faster glycemic control, lower total and LDL cholesterol levels and reduced short-term healthcare costs.     

瑞格列奈联合二甲双胍治疗2型糖尿病的疗效观察

目的 探讨瑞格列奈联合二甲双胍在2型糖尿病治疗中的应用价值.方法 选择2型糖尿病患者92例,随机分为观察组和对照组.两组患者均给予瑞格列奈治疗,观察组则在此基础上加用二甲双胍,并对两组患者的糖代谢和血脂以及体质量变化等临床疗效进行比较分析.结果 与对照组相比,观察组治愈率和总有效率分别为58.7％和97.8％,无效率为2.2％,差异均有统计学意义(x2=2.64,3.59,3.59,P＜0.05);观察组空腹血糖和餐后2h血糖以及糖化血红蛋白等糖代谢指标均显著降低(P＜0.05);观察组的三酰甘油和胆固醇等血脂指标以及体质量指数均显著降低(P＜0.05).结论 瑞格列奈联合二甲双胍对于提高2型糖尿病患者的临床疗效具有十分重要的意义.     

Efficacy and safety of saxagliptin in combination with insulin in Japanese patients with type 2 diabetes mellitus: a 16-week double-blind randomized controlled trial with a 36-week open-label extension

Background: We examined the efficacy and safety of saxagliptin as an add-on to insulin in Japanese patients with type 2 diabetes mellitus.

Research design and methods: We randomized 240 patients with type 2 diabetes mellitus on insulin monotherapy to 5-mg saxagliptin or placebo as add-on therapy for a 16-week, double-blind period. All patients received 5-mg saxagliptin and insulin for an additional 36 weeks (open-label extension). Change in hemoglobin A1c (HbA1c) at Week 16 was the main endpoint.

Results: At Week 16, the adjusted change in HbA1c from baseline increased by 0.51% with placebo and decreased by 0.40% with saxagliptin (difference ?0.92% [95% confidence interval ?1.07%, ?0.76%; p < 0.001]). In patients receiving saxagliptin, reductions in HbA1c at Week 16 were maintained to Week 52, while switching from placebo to saxagliptin resulted in a similar reduction in HbA1c. The incidence of hypoglycemia was not markedly increased with saxagliptin versus placebo in the double-blind period and did not increase substantially during the open-label extension period. The efficacy and safety of saxagliptin was similar between the elderly and non-elderly patient groups.

Conclusions: Adding saxagliptin to ongoing insulin therapy improved glycemic control and was well tolerated in Japanese patients with type 2 diabetes.     

Systematic review and meta-analysis of efficacy and safety of combinational therapy with metformin and dipeptidyl peptidase-4 inhibitors

Combinational therapies are often required in the management of type 2 diabetes mellitus (T2DM). Among the important candidates, dipeptidyl peptidase-4 inhibitors (DPPIs) and metformin combination (DPPI-MET) have shown promising endeavors. In order to examine the efficacy and safety of such a combination therapy in T2DM patients finding inadequate control with metformin, this systematic review and meta-analysis has been conducted. Literature search was made in multiple electronic databases. Inclusion criteria included; RCTs examining the efficacy and safety of DPPI-MET against placebo-MET or MET-only groups of T2DM patients by observing changes in disease endpoints including HbA1c and FPG, and the length of trial be at least 12 weeks. Mean differences based meta-analyses were performed and heterogeneity assessment was carried out. Nineteen studies were selected and included in the meta-analyses. DPPI-MET significantly improved all disease endpoints and the difference could be noticed up to 2 years in the majority of outcome measures. In comparison with PBO-MET, the DPPI-MET combinational therapy resulted in the percent HbA1c changes from baseline with a mean difference [95% CI] of −0.77 [−0.86, −0.69] in 3-month (P < 0.00001), −0.67 [−0.76, −0.59] in 6-month (P < 0.00001), −0.67 [−0.88, −0.47] in 1-year (P < 0.00001) and −0.36 [−0.53, −0.20] in 2-year trials (P < 0.0003). Reduction in body weight and safety profile in the treated and control groups were not different. A combinational therapy with DPPI and metformin significantly improves diabetes clinical indicators and this effect has been observed for up to 2 years herein. Safety and tolerability of DPPI-MET combination have been found well-manageable with a very similar adverse event profile in both treated and control groups.     

单用二甲双胍血糖控制不佳的2型糖尿病患者加用西格列汀及护理干预后的疗效观察

目的观察单用二甲双胍血糖控制不佳的2型糖尿病患者加用西格列汀并联合护理干预对患者血糖改善及生活质量的影响。方法选择2013年5-9月来我院就诊的单用二甲双胍至少1 500 mg/d治疗3个月以上,血糖控制不佳的2型糖尿病患者27例,加用西格列汀100 mg/d,持续治疗16周,并进行护理干预,观察治疗前后空腹血糖(FPG)、糖化血红蛋白(Hb A1c)、低密度胆固醇(LDL)的变化情况。结果加用西格列汀治疗并联合护理干预16周后,患者FPG、Hb A1c较治疗前显著下降(P<0.05),但LDL无显著变化(P>0.05),16周治疗期间无严重不良反应发生。结论对单用二甲双胍血糖控制不佳的2型糖尿病患者加用西格列汀及相应的护理干预措施后,血糖控制安全、有效,耐受性好。     

Achieving glycemic goal with initial versus sequential combination therapy using metformin and pioglitazone in type 2 diabetes mellitus

Abstract

Objective:

To compare glycemic goal achievement (HbA_1c?<?7%) in type 2 diabetes patients receiving initial metformin plus pioglitazone combination therapy and initial metformin monotherapy augmented with pioglitazone in a cohort follow-up study.