title: Long-term efficacy and safety of vildagliptin add-on therapy in type 2 diabetes mellitus with insulin treatment.
abstract: BACKGROUND
  The use of dipeptidyl peptidase (DPP)-4 inhibitors in patients with type 2 diabetes treated with insulin may be beneficial. However, the long-term efficacy and safety of vildagliptin add-on therapy in these patients remains unclear.
  
  
  METHODS
  A total of 73 patients with type 2 diabetes treated with insulin were randomly assigned to receive either add-on therapy of vildagliptin (n=37) or conventional therapy without DPP-4 inhibitors (n=36) for glucose control. Hemoglobin A1c (HbA1c) levels, dose and number of insulin injections, number of hypoglycemia episodes, and liver and renal function were monitored for 2years.
  
  
  RESULTS
  The baseline characteristics of subjects, including age, dose of insulin injections, or HbA1c levels, did not differ between the two groups. In the vildagliptin group, HbA1c levels significantly decreased and the significance of HbA1c reduction was maintained for 24months (from 8.0±1.2% to 7.4±1.0%, p<0.05, at the end of observational period). In addition, the dose and number of insulin injections significantly reduced (-5.6units, p<0.01, and -0.9 times, p<0.001). However, these parameters were unchanged in the control group. The number of patients who experienced three or more episodes of hypoglycemia per year was significantly lower in the vildagliptin group (n=4) than in the control group (n=11) (odds ratio, 0.28; 95% confidence interval, 0.08-0.97; p<0.05).
  
  
  CONCLUSIONS
  Vildagliptin as an add-on to insulin treatment for 24months was well tolerated and led to sustained reductions in HbA1c, the dose and number of insulin injections, and the risk of hypoglycemia.
authors.affiliation: Department of Internal Medicine 1, Shimane University, Faculty of Medicine, Japan. Electronic address: ippei.k@med.shimane-u.ac.jp.
authors.forename: Ippei
authors.initials: I
authors.lastname: Kanazawa
authors.affiliation: Department of Internal Medicine 1, Shimane University, Faculty of Medicine, Japan.
authors.forename: Ken-Ichiro
authors.initials: KI
authors.lastname: Tanaka
authors.affiliation: Department of Internal Medicine 1, Shimane University, Faculty of Medicine, Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Notsu
authors.affiliation: Department of Internal Medicine 1, Shimane University, Faculty of Medicine, Japan.
authors.forename: Sayuri
authors.initials: S
authors.lastname: Tanaka
authors.affiliation: Department of Internal Medicine 1, Shimane University, Faculty of Medicine, Japan.
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Kiyohara
authors.affiliation: Department of Internal Medicine 1, Shimane University, Faculty of Medicine, Japan.
authors.forename: Sayo
authors.initials: S
authors.lastname: Koike
authors.affiliation: Yamane Hospital, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Yamane
authors.affiliation: Department of Internal Medicine, Matsue City Hospital, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Tada
authors.affiliation: Department of Internal Medicine, Matsue City Hospital, Japan.
authors.forename: Motofumi
authors.initials: M
authors.lastname: Sasaki
authors.affiliation: Department of Internal Medicine 1, Shimane University, Faculty of Medicine, Japan.
authors.forename: Mika
authors.initials: M
authors.lastname: Yamauchi
authors.affiliation: Department of Internal Medicine 1, Shimane University, Faculty of Medicine, Japan.
authors.forename: Toshitsugu
authors.initials: T
authors.lastname: Sugimoto
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011759:Pyrrolidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin
keywords: HbA1c; Hypoglycemia; Insulin; Type 2 diabetes mellitus; Vildagliptin