title: Liraglutide is effective and well tolerated in combination with an oral antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 52-week, open-label, parallel-group trial.
abstract: BACKGROUND
  The safety and efficacy of liraglutide in combination with an oral antidiabetic drug (OAD) compared with combination of two OADs were assessed in Japanese patients with type 2 diabetes.
  
  
  METHODS
  This was a 52-week, open-label, parallel-group trial in which patients whose type 2 diabetes was inadequately controlled with a single OAD (glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) were randomized 2:1 to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group; n = 240) or pretrial OAD in combination with an additional OAD (additional OAD group; n = 120). The primary outcome measure was the incidence of adverse events (AEs).
  
  
  RESULTS
  Overall, 86.3% of patients in the liraglutide group and 85.0% of patients in the additional OAD group experienced AEs; these were similar in nature and severity. Adverse event rates were 361 and 331 per 100 patient-years of exposure, respectively. Confirmed hypoglycemia was rare (seven episodes in two patients on liraglutide, and two in two patients on additional OAD). There were no reported pancreatitis events, and no unexpected safety signals were identified. Mean reductions in glycosylated hemoglobin were significantly greater in the liraglutide group than the additional OAD group [estimated mean treatment difference -0.27% (95% confidence interval (CI) -0.44, -0.09; P = 0.0026)]; reductions in mean fasting plasma glucose levels were also greater with liraglutide [estimated mean difference -5.47 mg/dL (-0.30 mmol/L; 95% CI: -10.83, -0.10; P = 0.0458)].
  
  
  CONCLUSIONS
  Liraglutide was well tolerated and effective as combination therapy with an OAD in Japanese patients with type 2 diabetes.
authors.affiliation: Department of Internal Medicine Kawasaki Medical School Okayama Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Kaku
authors.affiliation: Tokyo-Eki Center-building Clinic Tokyo Japan.
authors.forename: Arihiro
authors.initials: A
authors.lastname: Kiyosue
authors.affiliation: Yuri Ono Clinic Hokkaido Japan.
authors.forename: Yuri
authors.initials: Y
authors.lastname: Ono
authors.affiliation: Shiraiwa Medical Clinic Osaka Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Shiraiwa
authors.affiliation: Takatsuki Red Cross Hospital Osaka Japan.
authors.forename: Shizuka
authors.initials: S
authors.lastname: Kaneko
authors.affiliation: Medical & Scientific Affairs Department Novo Nordisk Pharma Ltd Tokyo Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Nishijima
authors.affiliation: Medical and Science GLP-1 Novo Nordisk A/S Søborg Denmark.
authors.forename: Heidrun
authors.initials: H
authors.lastname: Bosch-Traberg
authors.affiliation: Kansai Electric Power Hospital Osaka Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Seino
mesh_terms: D000284:Administration, Oral; D000368:Aged; D044466:Asian People; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007564:Japan / Q000453:epidemiology; D000069450:Liraglutide / Q000008:administration & dosage*; D008297:Male; D008687:Metformin / Q000008:administration & dosage; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D000069450:Liraglutide; D008687:Metformin
keywords: Liraglutide; Oral antidiabetic drug; Type 2 diabetes mellitus
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