title: Clinical study of repaglinide efficacy and safety in type 2 diabetes mellitus patients with blood glucose levels inadequately controlled by sitagliptin.
abstract: OBJECTIVE
  The aim of the present study was to evaluate the long-term efficacy and safety of adding repaglinide in patients with type 2 diabetes mellitus whose blood glucose levels were not sufficiently controlled by treatment with a dipeptidyl peptidase-4 inhibitor, sitagliptin, in addition to diet and exercise therapies.
  
  
  METHODS
  This was a multicenter, uncontrolled, dose-titration study with a treatment period of 52 weeks. The primary end-point was the change in glycated hemoglobin levels from baseline.
  
  
  RESULTS
  The glycated hemoglobin level was 7.43 ± 0.57% (mean ± standard deviation) at baseline, and decreased to 6.93 ± 0.91% at the end of the study. The mean changes in glycated hemoglobin levels at 4 weeks and at the end of the study were -0.44 ± 0.28% and -0.50 ± 0.82%, respectively. The glycated hemoglobin-lowering effect was maintained for 52 weeks. The rate of adverse events was 86.0% (86/100), and there were 352 adverse events. The rate of adverse drug reactions was 21.0% (21/100). Hypoglycemia was reported in 5.0% (5/100) of patients, but there was no incidence of 'major hypoglycemia'.
  
  
  CONCLUSIONS
  Combination therapy with repaglinide and sitagliptin was considered effective for a long term without clinical safety problems in patients with type 2 diabetes mellitus.
authors.affiliation: Sportology Center Juntendo University Graduate School of Medicine Tokyo Japan.
authors.forename: Ryuzo
authors.initials: R
authors.lastname: Kawamori
authors.affiliation: Department of General Internal Medicine 1 Kawasaki Medical School Kurashiki Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Kaku
authors.affiliation: Department of Internal Medicine (I) Osaka Medical College Takatsuki Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Hanafusa
authors.affiliation: Sumitomo Dainippon Pharma Co., Ltd. Tokyo Japan.
authors.forename: Katsuhisa
authors.initials: K
authors.lastname: Ioriya
authors.affiliation: Clinical Research Support Center The Jikei University School of Medicine Tokyo Japan.
authors.forename: Shigeru
authors.initials: S
authors.lastname: Kageyama
authors.affiliation: Labor, Health and Welfare Organization Chubu-Rosai Hospital Nagoya Japan.
authors.forename: Nigishi
authors.initials: N
authors.lastname: Hotta
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects*; D002219:Carbamates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068900:Sitagliptin Phosphate / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D002219:Carbamates; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D010880:Piperidines; D000068900:Sitagliptin Phosphate; C517652:hemoglobin A1c protein, human; C072379:repaglinide
keywords: Combination drug therapy; Repaglinide; Sitagliptin