[Keynote Talk]: Treatment Satisfaction and Safety of Sitagliptin versus Pioglitazone in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy

Shahnaz Haque, Anandi Shukla, Sunita Singh, A. Kem
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Abstract

Background: This study was designed to assess the treatment satisfaction between Sitagliptin versus Pioglitazone added to Metformin in patients with type 2 diabetes mellitus (T2DM). Methods: We conducted a prospective, open label, randomized, parallel group study in SIMS, Hapur, U.P. Eligible patients fulfilling inclusion criteria were randomized into two groups having 25 patients in each group using tab Sitagliptin 100mg,tab Pioglitazone 30mg added to ongoing tab Metformin (500mg) therapy for 16 weeks. The follow-up visits were on weeks 4, 12 and 16. Results: 16 weeks later, addition of Sitagliptin 100mg compared to that of Pioglitazone 30mg to ongoing Metformin therapy provided similar glycosylated haemoglobin (HbA1c) lowering efficacy in patients with T2DM with inadequate glycemic control on metformin monotherapy. Change in HbA1c in group1 was -0.656±0.21% (p<0.0001) whereas in group 2 was -0.748±0.35% (p<0.0001). Hence decrease in HbA1c from baseline was more in group2.Both treatments were well tolerated with negligible risk of hypoglycaemia. Weight loss was observed with Sitagliptin in contrast to weight gain seen in Pioglitazone. Conclusions: In this study, Sitagliptin 100 mg along with metformin therapy in comparison to pioglitazone 30 mg plus metformin therapy was effective, well-tolerated and improved glycemic control in both the groups. Addition of pioglitazone had cause oedema and weight gain to the patients whereas sitagliptin caused weight loss in its patients.
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[主题演讲]:西格列汀与吡格列酮对二甲双胍单药控制不充分的2型糖尿病患者的治疗满意度和安全性
背景:本研究旨在评估西格列汀与吡格列酮联合二甲双胍治疗2型糖尿病(T2DM)患者的治疗满意度。方法:我们在美国西格列汀、Hapur、U.P.进行了一项前瞻性、开放标签、随机、平行组研究,符合纳入标准的患者随机分为两组,每组25例患者,使用西格列汀100mg、吡格列酮30mg加用二甲双胍(500mg)治疗16周。随访时间为第4周、第12周和第16周。结果:16周后,在正在进行的二甲双胍治疗中,西格列汀100mg与吡格列酮30mg相比,在单用二甲双胍治疗血糖控制不足的T2DM患者中,糖基化血红蛋白(HbA1c)的降低效果相似。1组HbA1c变化为-0.656±0.21% (p<0.0001), 2组HbA1c变化为-0.748±0.35% (p<0.0001)。因此,第2组的HbA1c较基线下降更多。两种治疗均耐受性良好,低血糖风险可忽略不计。西格列汀组体重减轻,而吡格列酮组体重增加。结论:在本研究中,与吡格列酮30 mg加二甲双胍治疗相比,西格列汀100 mg联合二甲双胍治疗有效,耐受性良好,两组血糖控制均得到改善。吡格列酮组患者出现水肿和体重增加,而西格列汀组患者出现体重减轻。
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