Anagliptin and sitagliptin as add-ons to metformin for patients with type 2 diabetes: A 24-week, multicentre, randomized, double-blind, active-controlled, phase III clinical trial with a 28-week extension

S. M. Jin, S. W. Park, K. H. Yoon, K. W. Min, K. H. Song, K. S. Park, J. Y. Park, I. B. Park, C. H. Chung, S. H. Baik, S. H. Choi, H. W. Lee, I. K. Lee, D. M. Kim, M. K. Lee

Research output: Contribution to journalLetter

9 Citations (Scopus)

Abstract

We conducted a 24-week, multicentre, double-blind, randomized study with a 28-week extension to compare the efficacy and safety of anagliptin and sitagliptin as an add-on to metformin in patients with type 2 diabetes. Patients inadequately controlled on metformin were randomized to either anagliptin (100mg twice daily, n=92) or sitagliptin (100mg once daily, n=88). The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24. The mean changes in HbA1c were -0.85±0.70% (p<0.0001) for anagliptin and -0.83±0.61% (p<0.0001) for sitagliptin, with a mean difference of -0.02% (95% confidence interval of difference, -0.22 to 0.18%). In both groups, the fasting proinsulin:insulin ratio significantly decreased from baseline, with improved insulin secretion. Safety profiles were similar in each group. In conclusion, the non-inferiority of the efficacy of anagliptin to sitagliptin as an add-on therapy was established with regard to efficacy and safety.

Original languageEnglish
Pages (from-to)511-515
Number of pages5
JournalDiabetes, Obesity and Metabolism
Volume17
Issue number5
DOIs
Publication statusPublished - 2015 May 1

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Phase III Clinical Trials
Metformin
Type 2 Diabetes Mellitus
Safety
Insulin
Proinsulin
Glycosylated Hemoglobin A
Double-Blind Method
Fasting
Confidence Intervals
Sitagliptin Phosphate
anagliptin
Therapeutics

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Jin, S. M. ; Park, S. W. ; Yoon, K. H. ; Min, K. W. ; Song, K. H. ; Park, K. S. ; Park, J. Y. ; Park, I. B. ; Chung, C. H. ; Baik, S. H. ; Choi, S. H. ; Lee, H. W. ; Lee, I. K. ; Kim, D. M. ; Lee, M. K. / Anagliptin and sitagliptin as add-ons to metformin for patients with type 2 diabetes : A 24-week, multicentre, randomized, double-blind, active-controlled, phase III clinical trial with a 28-week extension. In: Diabetes, Obesity and Metabolism. 2015 ; Vol. 17, No. 5. pp. 511-515.
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Anagliptin and sitagliptin as add-ons to metformin for patients with type 2 diabetes : A 24-week, multicentre, randomized, double-blind, active-controlled, phase III clinical trial with a 28-week extension. / Jin, S. M.; Park, S. W.; Yoon, K. H.; Min, K. W.; Song, K. H.; Park, K. S.; Park, J. Y.; Park, I. B.; Chung, C. H.; Baik, S. H.; Choi, S. H.; Lee, H. W.; Lee, I. K.; Kim, D. M.; Lee, M. K.

In: Diabetes, Obesity and Metabolism, Vol. 17, No. 5, 01.05.2015, p. 511-515.

Research output: Contribution to journalLetter

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T1 - Anagliptin and sitagliptin as add-ons to metformin for patients with type 2 diabetes

T2 - A 24-week, multicentre, randomized, double-blind, active-controlled, phase III clinical trial with a 28-week extension

AU - Jin, S. M.

AU - Park, S. W.

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AU - Min, K. W.

AU - Song, K. H.

AU - Park, K. S.

AU - Park, J. Y.

AU - Park, I. B.

AU - Chung, C. H.

AU - Baik, S. H.

AU - Choi, S. H.

AU - Lee, H. W.

AU - Lee, I. K.

AU - Kim, D. M.

AU - Lee, M. K.

PY - 2015/5/1

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N2 - We conducted a 24-week, multicentre, double-blind, randomized study with a 28-week extension to compare the efficacy and safety of anagliptin and sitagliptin as an add-on to metformin in patients with type 2 diabetes. Patients inadequately controlled on metformin were randomized to either anagliptin (100mg twice daily, n=92) or sitagliptin (100mg once daily, n=88). The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24. The mean changes in HbA1c were -0.85±0.70% (p<0.0001) for anagliptin and -0.83±0.61% (p<0.0001) for sitagliptin, with a mean difference of -0.02% (95% confidence interval of difference, -0.22 to 0.18%). In both groups, the fasting proinsulin:insulin ratio significantly decreased from baseline, with improved insulin secretion. Safety profiles were similar in each group. In conclusion, the non-inferiority of the efficacy of anagliptin to sitagliptin as an add-on therapy was established with regard to efficacy and safety.

AB - We conducted a 24-week, multicentre, double-blind, randomized study with a 28-week extension to compare the efficacy and safety of anagliptin and sitagliptin as an add-on to metformin in patients with type 2 diabetes. Patients inadequately controlled on metformin were randomized to either anagliptin (100mg twice daily, n=92) or sitagliptin (100mg once daily, n=88). The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24. The mean changes in HbA1c were -0.85±0.70% (p<0.0001) for anagliptin and -0.83±0.61% (p<0.0001) for sitagliptin, with a mean difference of -0.02% (95% confidence interval of difference, -0.22 to 0.18%). In both groups, the fasting proinsulin:insulin ratio significantly decreased from baseline, with improved insulin secretion. Safety profiles were similar in each group. In conclusion, the non-inferiority of the efficacy of anagliptin to sitagliptin as an add-on therapy was established with regard to efficacy and safety.

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