A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes

Hae Kyung Yang, Kyung Wan Min, Sung Woo Park, Choon Hee Chung, Kyong Soo Park, Sung Hee Choi, Ki Ho Song, Doo Man Kim, Moon Kyu Lee, Yeon Ah Sung, Sei-Hyun Baik, In Joo Kim, Bong Soo Cha, Jeong Hyun Park, Yu Bae Ahn, In Kyu Lee, Soon Jib Yoo, Jaetaek Kim, Ie Byung Park, Tae Sun Park & 1 others Kun Ho Yoon

Research output: Contribution to journalArticle

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Abstract

The aim of this study was to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes in a double-blind randomized placebo-controlled study. A total of 109 patients were randomized to 100 mg (n=37) or 200 mg (n=33) anagliptin twice daily or placebo (n=39). The primary objective was to alter HbA1c levels from baseline at a 24-week endpoint. The overall baseline mean age and body mass index were 56.20 ± 9.77 years and 25.01 ± 2.97 kg/m2, respectively, and the HbA1c level was of 7.14 ± 0.69 %. Anagliptin at 100 mg and 200 mg produced significant reductions in HbA1c (-0.50 ± 0.45 % and -0.51 ± 0.55%, respectively), and the placebo treatment resulted in an increase in HbA1c by 0.23 ± 0.62 %. Both doses of anagliptin produced significant decreases in fasting plasma glucose (-0.53 ± 1.25 mmol/L and -0.72 ± 1.25 mmol/L, respectively) and the proinsulin/insulin ratio (-0.04 ± 0.15 and -0.07 ± 0.18, respectively) compared with placebo. No meaningful body weight changes from baseline were observed in three groups. Plasma dipeptidyl peptidase (DPP)-4 activity was significantly inhibited after 24 weeks of anagliptin treatment, and >75% and >90% inhibitions were observed during the meal tolerance tests with 100 mg and 200 mg anagliptin, respectively. The incidences of adverse or serious adverse events were similar among the three study groups. Twice-daily anagliptin therapy effectively inhibited DPP-4 activity and improved glycemic control and was well-tolerated in patients with type 2 diabetes.

Original languageEnglish
Pages (from-to)449-462
Number of pages14
JournalEndocrine Journal
Volume62
Issue number5
DOIs
Publication statusPublished - 2015 Jan 1

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Type 2 Diabetes Mellitus
Placebos
Safety
Pharmaceutical Preparations
Dipeptidyl Peptidase 4
Proinsulin
Body Weight Changes
anagliptin
Meals
Fasting
Body Mass Index
Therapeutics
Insulin
Glucose
Incidence

Keywords

  • DPP-4 inhibitor
  • Glycemic control
  • Type 2 diabetes

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes. / Yang, Hae Kyung; Min, Kyung Wan; Park, Sung Woo; Chung, Choon Hee; Park, Kyong Soo; Choi, Sung Hee; Song, Ki Ho; Kim, Doo Man; Lee, Moon Kyu; Sung, Yeon Ah; Baik, Sei-Hyun; Kim, In Joo; Cha, Bong Soo; Park, Jeong Hyun; Ahn, Yu Bae; Lee, In Kyu; Yoo, Soon Jib; Kim, Jaetaek; Park, Ie Byung; Park, Tae Sun; Yoon, Kun Ho.

In: Endocrine Journal, Vol. 62, No. 5, 01.01.2015, p. 449-462.

Research output: Contribution to journalArticle

Yang, HK, Min, KW, Park, SW, Chung, CH, Park, KS, Choi, SH, Song, KH, Kim, DM, Lee, MK, Sung, YA, Baik, S-H, Kim, IJ, Cha, BS, Park, JH, Ahn, YB, Lee, IK, Yoo, SJ, Kim, J, Park, IB, Park, TS & Yoon, KH 2015, 'A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes', Endocrine Journal, vol. 62, no. 5, pp. 449-462. https://doi.org/10.1507/endocrj.EJ14-0544
Yang, Hae Kyung ; Min, Kyung Wan ; Park, Sung Woo ; Chung, Choon Hee ; Park, Kyong Soo ; Choi, Sung Hee ; Song, Ki Ho ; Kim, Doo Man ; Lee, Moon Kyu ; Sung, Yeon Ah ; Baik, Sei-Hyun ; Kim, In Joo ; Cha, Bong Soo ; Park, Jeong Hyun ; Ahn, Yu Bae ; Lee, In Kyu ; Yoo, Soon Jib ; Kim, Jaetaek ; Park, Ie Byung ; Park, Tae Sun ; Yoon, Kun Ho. / A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes. In: Endocrine Journal. 2015 ; Vol. 62, No. 5. pp. 449-462.
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