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, Sei-Hyun Baik, S. H. Choi, H. W. Lee, I. K. Lee, D. M. Kim, M. K. Lee

Research output: Contribution to journalLetter

8 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

Fingerprint

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

Keywords

  • Antidiabetic drug
  • Diabetes care
  • DPP-IV inhibitor
  • Incretin therapy

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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, Sei-Hyun; 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

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, Sei-Hyun ; 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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AU - Chung, C. H.

AU - Baik, Sei-Hyun

AU - Choi, S. H.

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