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The safety and efficacy of liraglutide in combination with an oral antidiabetic drug ( OAD ) compared with combination of two  OAD s were assessed in Japanese patients with type 2 diabetes.    Materials and 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 ( AE s).    Results  Overall, 86.3% of patients in the liraglutide group and 85.0% of patients in the additional  OAD  group experienced  AE s; 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.

journal of diabetes investigation

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