Efficacy and safety of the dipeptidyl peptidase-4 inhibitor gemigliptin compared with sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone

E. J. Rhee, W. Y. Lee, K. W. Min, V. K. Shivane, A. R. Sosale, H. C. Jang, C. H. Chung, I. S. Nam-Goong, J. A. Kim, S. W. Kim

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Abstract

Aims: This study was designed to assess the efficacy and safety of a dipeptidyl peptidase-4 inhibitor, gemigliptin versus sitagliptin added to metformin in patients with type 2 diabetes. Methods: We conducted a double-blind, randomized, active-controlled trial in 425 Asian patients with inadequately controlled type 2 diabetes being treated with metformin alone. Eligible patients were randomized into three groups: 50mg gemigliptin qd, 25mg gemigliptin bid or sitagliptin 100mg qd added to ongoing metformin treatment for 24weeks. Haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) were measured periodically, and oral glucose tolerance tests were performed at baseline and 24weeks after starting the treatment regimen. Results: Twenty-four weeks later, adding gemigliptin (50mg/day) to ongoing metformin therapy significantly improved glycaemic control. Reduction in HbA1c caused by 50mg gemigliptin qd (-0.77%±0.8) was non-inferior to that caused by 100mg sitagliptin qd (-0.8%±0.85). Proportion of patients achieving HbA1c <7% while taking 25mg gemigliptin bid (50%) or 50mg gemigliptin qd (54.07%) was comparable to the results with 100mg sitagliptin qd (48.87%). There were significant decreases in FPG, postprandial glucose and AUC0-2h glucose, as well as increases in GLP-1 and β cell sensitivity to glucose (supported by homeostasis model assessment of β-cell function, postprandial 2-h c-peptide and insulinogenic index) in patients receiving gemigliptin treatment with their metformin therapy. There was no increased risk of adverse effects with this dose of gemigliptin compared with sitagliptin 100mg qd. Conclusions: Addition of gemigliptin 50mg daily to metformin was shown to be efficacious, well tolerated and non-inferior to sitagliptin in patients with type 2 diabetes mellitus.

Original languageEnglish
Pages (from-to)523-530
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume15
Issue number6
DOIs
Publication statusPublished - 2013 Jun 1

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Dipeptidyl-Peptidase IV Inhibitors
Metformin
Type 2 Diabetes Mellitus
Safety
Glucose
Therapeutics
Hemoglobins
Fasting
Sitagliptin Phosphate
LC15-0444
Glucagon-Like Peptide 1
Glucose Tolerance Test
Homeostasis
Randomized Controlled Trials

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Rhee, E. J. ; Lee, W. Y. ; Min, K. W. ; Shivane, V. K. ; Sosale, A. R. ; Jang, H. C. ; Chung, C. H. ; Nam-Goong, I. S. ; Kim, J. A. ; Kim, S. W. / Efficacy and safety of the dipeptidyl peptidase-4 inhibitor gemigliptin compared with sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. In: Diabetes, Obesity and Metabolism. 2013 ; Vol. 15, No. 6. pp. 523-530.
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Efficacy and safety of the dipeptidyl peptidase-4 inhibitor gemigliptin compared with sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. / Rhee, E. J.; Lee, W. Y.; Min, K. W.; Shivane, V. K.; Sosale, A. R.; Jang, H. C.; Chung, C. H.; Nam-Goong, I. S.; Kim, J. A.; Kim, S. W.

In: Diabetes, Obesity and Metabolism, Vol. 15, No. 6, 01.06.2013, p. 523-530.

Research output: Contribution to journalArticle

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T1 - Efficacy and safety of the dipeptidyl peptidase-4 inhibitor gemigliptin compared with sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone

AU - Rhee, E. J.

AU - Lee, W. Y.

AU - Min, K. W.

AU - Shivane, V. K.

AU - Sosale, A. R.

AU - Jang, H. C.

AU - Chung, C. H.

AU - Nam-Goong, I. S.

AU - Kim, J. A.

AU - Kim, S. W.

PY - 2013/6/1

Y1 - 2013/6/1

N2 - Aims: This study was designed to assess the efficacy and safety of a dipeptidyl peptidase-4 inhibitor, gemigliptin versus sitagliptin added to metformin in patients with type 2 diabetes. Methods: We conducted a double-blind, randomized, active-controlled trial in 425 Asian patients with inadequately controlled type 2 diabetes being treated with metformin alone. Eligible patients were randomized into three groups: 50mg gemigliptin qd, 25mg gemigliptin bid or sitagliptin 100mg qd added to ongoing metformin treatment for 24weeks. Haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) were measured periodically, and oral glucose tolerance tests were performed at baseline and 24weeks after starting the treatment regimen. Results: Twenty-four weeks later, adding gemigliptin (50mg/day) to ongoing metformin therapy significantly improved glycaemic control. Reduction in HbA1c caused by 50mg gemigliptin qd (-0.77%±0.8) was non-inferior to that caused by 100mg sitagliptin qd (-0.8%±0.85). Proportion of patients achieving HbA1c <7% while taking 25mg gemigliptin bid (50%) or 50mg gemigliptin qd (54.07%) was comparable to the results with 100mg sitagliptin qd (48.87%). There were significant decreases in FPG, postprandial glucose and AUC0-2h glucose, as well as increases in GLP-1 and β cell sensitivity to glucose (supported by homeostasis model assessment of β-cell function, postprandial 2-h c-peptide and insulinogenic index) in patients receiving gemigliptin treatment with their metformin therapy. There was no increased risk of adverse effects with this dose of gemigliptin compared with sitagliptin 100mg qd. Conclusions: Addition of gemigliptin 50mg daily to metformin was shown to be efficacious, well tolerated and non-inferior to sitagliptin in patients with type 2 diabetes mellitus.

AB - Aims: This study was designed to assess the efficacy and safety of a dipeptidyl peptidase-4 inhibitor, gemigliptin versus sitagliptin added to metformin in patients with type 2 diabetes. Methods: We conducted a double-blind, randomized, active-controlled trial in 425 Asian patients with inadequately controlled type 2 diabetes being treated with metformin alone. Eligible patients were randomized into three groups: 50mg gemigliptin qd, 25mg gemigliptin bid or sitagliptin 100mg qd added to ongoing metformin treatment for 24weeks. Haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) were measured periodically, and oral glucose tolerance tests were performed at baseline and 24weeks after starting the treatment regimen. Results: Twenty-four weeks later, adding gemigliptin (50mg/day) to ongoing metformin therapy significantly improved glycaemic control. Reduction in HbA1c caused by 50mg gemigliptin qd (-0.77%±0.8) was non-inferior to that caused by 100mg sitagliptin qd (-0.8%±0.85). Proportion of patients achieving HbA1c <7% while taking 25mg gemigliptin bid (50%) or 50mg gemigliptin qd (54.07%) was comparable to the results with 100mg sitagliptin qd (48.87%). There were significant decreases in FPG, postprandial glucose and AUC0-2h glucose, as well as increases in GLP-1 and β cell sensitivity to glucose (supported by homeostasis model assessment of β-cell function, postprandial 2-h c-peptide and insulinogenic index) in patients receiving gemigliptin treatment with their metformin therapy. There was no increased risk of adverse effects with this dose of gemigliptin compared with sitagliptin 100mg qd. Conclusions: Addition of gemigliptin 50mg daily to metformin was shown to be efficacious, well tolerated and non-inferior to sitagliptin in patients with type 2 diabetes mellitus.

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