title: Efficacy and safety of sitagliptin added to insulin in Japanese patients with type 2 diabetes: the EDIT randomized trial.
abstract: OBJECTIVE
  To clarify the efficacy and safety of adding sitagliptin to insulin therapy in Japanese patients with suboptimally controlled type 2 diabetes (T2DM).
  
  
  METHODS
  This was a 24-week, prospective, randomized, open-labeled, controlled trial. Patients with T2DM who were suboptimally controlled despite receiving at least twice daily injection of insulin were enrolled in the study. The patients were randomized to continuation of insulin treatment (Insulin group) or addition of sitagliptin 50 to 100 mg daily to insulin treatment (Ins+Sita group). The primary outcome was change in HbA1c at week 24.
  
  
  RESULTS
  Adding sitagliptin to insulin significantly reduced HbA1c from 7.9 ± 1.0% at baseline to 7.0 ± 0.8% at week 24 (P <0.0001), while there was no significant change in HbA1c in the Insulin group (7.8 ± 0.7% vs. 7.8 ± 1.1%, P = 0.32). The difference in HbA1c reduction between the groups was 0.9% (95% confidence interval, 0.4 to 1.5, P = 0.01). There was no significant weight gain in either group. Incidence of hypoglycemia was significantly reduced in the Ins+Sita group compared with the Insulin group. Treatment satisfaction was improved in the Ins+Sita group. Baseline HbA1c level and beta cell function were associated with the magnitude of reduction in HbA1c in the Ins+Sita group.
  
  
  CONCLUSIONS
  Adding sitagliptin to insulin reduced HbA1c without weight gain or increase in hypoglycemia, and improved treatment satisfaction in Japanese patients with T2DM who were suboptimally controlled despite at least twice daily injection of insulin.
  
  
  BACKGROUND
  The University Hospital Medical Information Network (UMIN) Clinical Trials Registry UMIN000004678.
authors: Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors: Seiji
authors: S
authors: Sato
authors: Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors: Yoshifumi
authors: Y
authors: Saisho
authors: Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors: Kinsei
authors: K
authors: Kou
authors: Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors: Shu
authors: S
authors: Meguro
authors: Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors: Masami
authors: M
authors: Tanaka
authors: Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors: Junichiro
authors: J
authors: Irie
authors: Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors: Toshihide
authors: T
authors: Kawai
authors: Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
authors: Hiroshi
authors: H
authors: Itoh
mesh_terms: D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000652:urine; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use; D007564:Japan; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D000068900:Sitagliptin Phosphate / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D000068900:Sitagliptin Phosphate; C517652:hemoglobin A1c protein, human