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

Title
A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naive patients with type 2 diabetes
Authors
Yang, Hae KyungMin, Kyung WanPark, Sung WooChung, Choon HeeParks, Kyong SooChoi, Sung HeeSong, Ki-HoKim, Doo-ManLee, Moon-KyuSung, Yeon-AhBaik, Sei HyunKim, In JooCha, Bong-SooPark, Jeong HyunAhn, Yu BaeLee, In-KyuYoo, Soon JibKim, JaetaekPark, Ie ByungPark, Tae SunYoon, Kun-Ho
Ewha Authors
성연아
SCOPUS Author ID
성연아scopus
Issue Date
2015
Journal Title
ENDOCRINE JOURNAL
ISSN
0918-8959JCR Link1348-4540JCR Link
Citation
vol. 62, no. 5, pp. 449 - 462
Keywords
DPP-4 inhibitorGlycemic controlType 2 diabetes
Publisher
JAPAN ENDOCRINE SOC
Indexed
SCI; SCIE; SCOPUS WOS scopus
Abstract
The aim of this study was to evaluate the efficacy and safety of anagliptin in drug-nave 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/m(2), 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.
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의학전문대학원 > 의학과 > Journal papers
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