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

Ajay Kumar Ajmani, Aparna Agrawal, B. L.N. Prasad, Indraneel Basu, Jayashree Shembalkar, Neeraj Manikanth, K. A.V. Subrahmanyam, M. Srinivasa, Manoj Chawla, Manoj Kumar Srivastava, Felix Jebasingh, Basavaprabhu Achappa, R. P. Agrawal, Rakesh K. Pulichikkat, Ramdhan Meena, Shailaja Bhatia, Sandeep Kumar Gupta, Amol Dange, Ambrish Srivastava, Abhijit Trailokya & 2 others Vinayaka Shahavi, Sachin Shende

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article number107860
JournalDiabetes Research and Clinical Practice
Volume157
DOIs
Publication statusPublished - 01-11-2019

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Metformin
Type 2 Diabetes Mellitus
Safety
Therapeutics
Body Weight Changes
4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one
Sitagliptin Phosphate

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Ajmani, Ajay Kumar ; Agrawal, Aparna ; Prasad, B. L.N. ; Basu, Indraneel ; Shembalkar, Jayashree ; Manikanth, Neeraj ; Subrahmanyam, K. A.V. ; Srinivasa, M. ; Chawla, Manoj ; Srivastava, Manoj Kumar ; Jebasingh, Felix ; Achappa, Basavaprabhu ; Agrawal, R. P. ; Pulichikkat, Rakesh K. ; Meena, Ramdhan ; Bhatia, Shailaja ; Gupta, Sandeep Kumar ; Dange, Amol ; Srivastava, Ambrish ; Trailokya, Abhijit ; Shahavi, Vinayaka ; Shende, Sachin. / 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. In: Diabetes Research and Clinical Practice. 2019 ; Vol. 157.
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title = "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",
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.",
author = "Ajmani, {Ajay Kumar} and Aparna Agrawal and Prasad, {B. L.N.} and Indraneel Basu and Jayashree Shembalkar and Neeraj Manikanth and Subrahmanyam, {K. A.V.} and M. Srinivasa and Manoj Chawla and Srivastava, {Manoj Kumar} and Felix Jebasingh and Basavaprabhu Achappa and Agrawal, {R. P.} and Pulichikkat, {Rakesh K.} and Ramdhan Meena and Shailaja Bhatia and Gupta, {Sandeep Kumar} and Amol Dange and Ambrish Srivastava and Abhijit Trailokya and Vinayaka Shahavi and Sachin Shende",
year = "2019",
month = "11",
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doi = "10.1016/j.diabres.2019.107860",
language = "English",
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journal = "Diabetes Research and Clinical Practice",
issn = "0168-8227",
publisher = "Elsevier Ireland Ltd",

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Ajmani, AK, Agrawal, A, Prasad, BLN, Basu, I, Shembalkar, J, Manikanth, N, Subrahmanyam, KAV, Srinivasa, M, Chawla, M, Srivastava, MK, Jebasingh, F, Achappa, B, Agrawal, RP, Pulichikkat, RK, Meena, R, Bhatia, S, Gupta, SK, Dange, A, Srivastava, A, Trailokya, A, Shahavi, V & Shende, S 2019, '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', Diabetes Research and Clinical Practice, vol. 157, 107860. https://doi.org/10.1016/j.diabres.2019.107860

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. / Ajmani, Ajay Kumar; Agrawal, Aparna; Prasad, B. L.N.; Basu, Indraneel; Shembalkar, Jayashree; Manikanth, Neeraj; Subrahmanyam, K. A.V.; Srinivasa, M.; Chawla, Manoj; Srivastava, Manoj Kumar; Jebasingh, Felix; Achappa, Basavaprabhu; Agrawal, R. P.; Pulichikkat, Rakesh K.; Meena, Ramdhan; Bhatia, Shailaja; Gupta, Sandeep Kumar; Dange, Amol; Srivastava, Ambrish; Trailokya, Abhijit; Shahavi, Vinayaka; Shende, Sachin.

In: Diabetes Research and Clinical Practice, Vol. 157, 107860, 01.11.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of evogliptin versus sitagliptin as an add-on therapy in Indian patients with type 2 diabetes mellitus inadequately controlled with metformin

T2 - A 24-week randomized, double-blind, non-inferiority, EVOLUTION INDIA study

AU - Ajmani, Ajay Kumar

AU - Agrawal, Aparna

AU - Prasad, B. L.N.

AU - Basu, Indraneel

AU - Shembalkar, Jayashree

AU - Manikanth, Neeraj

AU - Subrahmanyam, K. A.V.

AU - Srinivasa, M.

AU - Chawla, Manoj

AU - Srivastava, Manoj Kumar

AU - Jebasingh, Felix

AU - Achappa, Basavaprabhu

AU - Agrawal, R. P.

AU - Pulichikkat, Rakesh K.

AU - Meena, Ramdhan

AU - Bhatia, Shailaja

AU - Gupta, Sandeep Kumar

AU - Dange, Amol

AU - Srivastava, Ambrish

AU - Trailokya, Abhijit

AU - Shahavi, Vinayaka

AU - Shende, Sachin

PY - 2019/11/1

Y1 - 2019/11/1

N2 - 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.

AB - 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.

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