Abstract
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% ≤ HbA1c < 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 HbA1c 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 HbA1c < 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 HbA1c reduction. It effectively improved glycemic control and was well tolerated in type
2 diabetes patients inadequately controlled by metformin alone.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Diabetes Research and Clinical PracticeAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- IDF Diabetes Atlas.International Diabetes Federation, Brussels, Belgium2017 ([Accessed 22 October 2018])
- India State-Level Disease Burden Initiative Diabetes Collaborators. The increasing burden of diabetes and variations among the states of India: the global burden of disease study 1990–2016.Lancet Glob Health. 2018; 6: e1352-e1362https://doi.org/10.1016/S2214-109X(18)30387-5
- RSSDI clinical practice recommendations for the management of type 2 diabetes mellitus 2017.Int J Diabetes Dev Ctries. 2018; 38: 1-115https://doi.org/10.1007/s13410-018-0604-7
- Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2018.Diabetes Care. 2018; 41: S73-S85https://doi.org/10.2337/dc18-S008
International Diabetes Federation. Recommendations for managing type 2 diabetes in primary care, 2017. www.idf.org/managing-type2-diabetes. [Accessed 23 October 2018].
- Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm–2016 executive summary.Endocr Pract. 2016; 22: 84-113https://doi.org/10.4158/EP151126.CS
- Unraveling the science of incretin biology.Am J Med. 2009; 122: S3-S10https://doi.org/10.1016/j.amjmed.2009.03.012
- SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus.N Engl J Med. 2013; 369: 1317-1326https://doi.org/10.1056/NEJMoa1307684
- Effect of Sitagliptin on cardiovascular outcomes in type 2 diabetes.N Engl J Med. 2015; 373: 232-242https://doi.org/10.1056/NEJMoa1501352
- Alogliptin after acute coronary syndrome in patients with type 2 diabetes.N Engl J Med. 2013; 369: 1327-1335https://doi.org/10.1056/NEJMoa1305889
- Multiple-dose pharmacokinetics and pharmacodynamics of evogliptin (DA-1229), a novel dipeptidyl peptidase IV inhibitor, in healthy volunteers.Drug Des Devel Ther. 2014; 8: 1709-1721https://doi.org/10.2147/DDDT.S65678
- A randomized, double-blind, placebo-controlled, phase II clinical trial to investigate the efficacy and safety of oral DA-1229 in patients with type 2 diabetes mellitus who have inadequate glycaemic control with diet and exercise.Diabetes Metab Res Rev. 2015; 31: 295-306https://doi.org/10.1002/dmrr.2613
- Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise.Diabetes Obes Metab. 2017; 19: 1681-1687https://doi.org/10.1111/dom.12987
- Effects of renal impairment on the pharmacokinetics and pharmacodynamics of a novel dipeptidyl peptidase-4 inhibitor, evogliptin (DA-1229).Diabetes Obes Metab. 2017; 19: 294-298https://doi.org/10.1111/dom.12813
- Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension.Diabetes Obes Metab. 2017; 19: 654-663https://doi.org/10.1111/dom.12870
- Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes.Curr Med Res Opin. 2007; 23: 1329-1339https://doi.org/10.1185/030079907X188152
- Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes: vildagliptin (LAF237) dose response.Diabetes Obes Metab. 2005; 7: 692-698https://doi.org/10.1111/j.1463-1326.2005.00539.x
- Efficacy and safety of saxagliptin in combination with metformin compared with sitagliptin in combination with metformin in adult patients with type 2 diabetes mellitus.Diabetes Metab Res Rev. 2010; 26: 540-549https://doi.org/10.1002/dmrr.1114
- Systematic review and meta-analysis of efficacy and safety of combinational therapy with metformin and dipeptidyl peptidase-4 inhibitors.Saudi Pharm J. 2015; 23: 603-613https://doi.org/10.1016/j.jsps.2013.12.018
Article info
Publication history
Published online: September 14, 2019
Accepted:
September 13,
2019
Received in revised form:
July 18,
2019
Received:
April 26,
2019
Identification
Copyright
© 2019 Elsevier B.V. All rights reserved.
