Efficacy and safety of evogliptin versus sitagliptin as an add-on therapy in Indian patients with type 2 diabetes mellitus inadequately controlled with metformin: A 24-week randomized, double-blind, non-inferiority, EVOLUTION INDIA study

被引：8

作者：

Ajmani, Ajay Kumar ^{[1
]}

Agrawal, Aparna ^{[2
,3
]}

Prasad, B. L. N. ^{[4
,5
]}

Basu, Indraneel ^{[6
]}

Shembalkar, Jayashree ^{[7
]}

Manikanth, Neeraj ^{[8
]}

Subrahmanyam, K. A. V. ^{[9
]}

Srinivasa, M. ^{[10
]}

Chawla, Manoj ^{[11
]}

Srivastava, Manoj Kumar ^{[12
]}

Jebasingh, Felix ^{[13
]}

Achappa, Basavaprabhu ^{[14
]}

Agrawal, R. P. ^{[15
]}

Pulichikkat, Rakesh K. ^{[16
]}

Meena, Ramdhan ^{[17
]}

Bhatia, Shailaja ^{[18
]}

Gupta, Sandeep Kumar ^{[19
]}

Dange, Amol ^{[20
]}

Srivastava, Ambrish ^{[21
]}

Trailokya, Abhijit ^{[21
]}

Shahavi, Vinayaka ^{[21
]}

Shende, Sachin ^{[21
]}

机构：

[1] Dr BL Kapur Super Special Hosp, New Delhi, India

[2] Lady Hardinge Med Coll & Hosp, New Delhi, India

[3] Smt Sucheta Kriplani Hosp, New Delhi, India

[4] Rajiv Gandhi Inst Med Sci, Srikakulam, India

[5] RIMS Govt Gen Hosp, Srikakulam, India

[6] Popular Hosp, Varanasi, Uttar Pradesh, India

[7] Getwell Hosp & Res Inst, Nagpur, Maharashtra, India

[8] Govt Med Coll, Parippally, Kerala, India

[9] King George Hosp, Andhra Med Coll, Vishakhapatnam, India

[10] Mysore Med Coll & Res Inst, Krishna Rajendra Hosp, Mysore, Karnataka, India

[11] BSES Municipal Gen Hosp, Mumbai, Maharashtra, India

[12] Om Surg Ctr Matern Home, Varanasi, Uttar Pradesh, India

[13] Christian Med Coll & Hosp, Vellore, Tamil Nadu, India

[14] Kasturba Med Coll & Hosp, Mangalore, India

[15] SP Med Coll & PBM Hosp, Bikaner, India

[16] Sree Narayana Inst Med Sci, Kochi, Kerala, India

[17] SR Kalla Mem Gastro & Gen Hosp, Jaipur, Rajasthan, India

[18] Medipoint Hosp Put Ltd, Pune, Maharashtra, India

[19] KRM Hosp & Res Ctr, Lucknow, Uttar Pradesh, India

[20] Lifepoint Multispecialty Hosp, Pune, Maharashtra, India

[21] Alkem Labs Ltd, Mumbai, Maharashtra, India

来源：

DIABETES RESEARCH AND CLINICAL PRACTICE | 2019年 / 157卷

关键词：

Evogliptin; Dipeptidyl peptidase-4 inhibitor; Type 2 diabetes mellitus; Sitagliptin; GLYCEMIC CONTROL; INHIBITOR; DA-1229; TRIAL; DIET;

D O I：

10.1016/j.diabres.2019.107860

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aim: This study aimed to assess efficacy and safety of evogliptin versus sitagliptin, when added to background metformin therapy in Indian patients with uncontrolled type 2 diabetes. Method: Overall, 184 patients with uncontrolled type 2 diabetes (7% <= HbA(1c) < 10%) receiving >= 8 weeks of stable metformin monotherapy (>= 1 g/day), were randomized to receive add-on treatment (evogliptin 5 mg or sitagliptin 100 mg) for 24 weeks. Primary endpoint was change in HbA(1c) from baseline to 12 weeks (non-inferiority margin: <0.35). Results: Mean reductions in HbA1c at 12 weeks in evogliptin- and sitagliptin-treated patients were -0.37 (1.06) and -0.32 (1.14), respectively. The adjusted mean difference between treatment groups was -0.022 (95% CI: -0.374, 0.330; P = 0.901), that demonstrated non-inferiority. Reductions in FPG and PPG were similar between evogliptin and sitagliptin at 12 and 24 weeks. Changes in body weight were comparable between the treatment groups. Patients achieving target HbA(1c) < 7.0% (evogliptin, 26.7% vs. sitagliptin, 20%) was almost equal in both groups. Treatment-emergent adverse events occured in 52 patients (evogliptin, 25% and sitagliptin, 31.5%) and were generally mild. Conclusions: Evogliptin was non-inferior to sitagliptin in HbA(1c) reduction. It effectively improved glycemic control and was well tolerated in type 2 diabetes patients inadequately controlled by metformin alone. (C) 2019 Elsevier B.V. All rights reserved.

引用

页数：8

共 19 条

[1] Systematic review and meta-analysis of efficacy and safety of combinational therapy with metformin and dipeptidyl peptidase-4 inhibitors [J].