title: 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.
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 (100 mg twice daily, n = 92) or sitagliptin (100 mg 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.
authors.affiliation: Department of Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: S-M
authors.initials: SM
authors.lastname: Jin
authors.forename: S W
authors.initials: SW
authors.lastname: Park
authors.forename: K-H
authors.initials: KH
authors.lastname: Yoon
authors.forename: K W
authors.initials: KW
authors.lastname: Min
authors.forename: K-H
authors.initials: KH
authors.lastname: Song
authors.forename: K S
authors.initials: KS
authors.lastname: Park
authors.forename: J-Y
authors.initials: JY
authors.lastname: Park
authors.forename: I B
authors.initials: IB
authors.lastname: Park
authors.forename: C H
authors.initials: CH
authors.lastname: Chung
authors.forename: S H
authors.initials: SH
authors.lastname: Baik
authors.forename: S H
authors.initials: SH
authors.lastname: Choi
authors.forename: H W
authors.initials: HW
authors.lastname: Lee
authors.forename: I-K
authors.initials: IK
authors.lastname: Lee
authors.forename: D-M
authors.initials: DM
authors.lastname: Kim
authors.forename: M-K
authors.initials: MK
authors.lastname: Lee
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005215:Fasting / Q000097:blood; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008687:Metformin / Q000627:therapeutic use*; D011384:Proinsulin / Q000097:blood / Q000378:metabolism; D011743:Pyrimidines / Q000627:therapeutic use*; D000068900:Sitagliptin Phosphate / Q000627:therapeutic use*
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D011384:Proinsulin; D011743:Pyrimidines; D000068900:Sitagliptin Phosphate; C517652:hemoglobin A1c protein, human; C583175:anagliptin
keywords: DPP-IV inhibitor; antidiabetic drug; diabetes care; incretin therapy