title: 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.
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/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.
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, 137-701, Korea.
authors.forename: Hae Kyung
authors.initials: HK
authors.lastname: Yang
authors.forename: Kyung Wan
authors.initials: KW
authors.lastname: Min
authors.forename: Sung Woo
authors.initials: SW
authors.lastname: Park
authors.forename: Choon Hee
authors.initials: CH
authors.lastname: Chung
authors.forename: Kyong Soo
authors.initials: KS
authors.lastname: Park
authors.forename: Sung Hee
authors.initials: SH
authors.lastname: Choi
authors.forename: Ki-Ho
authors.initials: KH
authors.lastname: Song
authors.forename: Doo-Man
authors.initials: DM
authors.lastname: Kim
authors.forename: Moon-Kyu
authors.initials: MK
authors.lastname: Lee
authors.forename: Yeon-Ah
authors.initials: YA
authors.lastname: Sung
authors.forename: Sei Hyun
authors.initials: SH
authors.lastname: Baik
authors.forename: In Joo
authors.initials: IJ
authors.lastname: Kim
authors.forename: Bong-Soo
authors.initials: BS
authors.lastname: Cha
authors.forename: Jeong Hyun
authors.initials: JH
authors.lastname: Park
authors.forename: Yu Bae
authors.initials: YB
authors.lastname: Ahn
authors.forename: In-Kyu
authors.initials: IK
authors.lastname: Lee
authors.forename: Soon Jib
authors.initials: SJ
authors.lastname: Yoo
authors.forename: Jaetaek
authors.initials: J
authors.lastname: Kim
authors.forename: Ie Byung
authors.initials: IeB
authors.lastname: Park
authors.forename: Tae Sun
authors.initials: TS
authors.lastname: Park
authors.forename: Kun-Ho
authors.initials: KH
authors.lastname: Yoon
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D018819:Dipeptidyl Peptidase 4 / Q000097:blood; D054873:Dipeptidyl-Peptidase IV Inhibitors; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007328:Insulin / Q000097:blood; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011384:Proinsulin / Q000097:blood; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D018819:Dipeptidyl Peptidase 4; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007328:Insulin; D010919:Placebos; D011384:Proinsulin; D011743:Pyrimidines; C583175:anagliptin