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Background  Gemigliptin is a new dipeptidyl peptidase‐ IV  inhibitor. We investigated the efficacy and safety of initial combination therapy with gemigliptin and metformin compared with monotherapy with either drug in patients with type 2 diabetes ( T2D ).    Methods  A total of 433  T2D  patients with a glycosylated haemoglobin ( HbA1c ) level of 7.5% to 11.0% and a fasting plasma glucose ( FPG ) concentration <270 mg/dL were randomly assigned to 3 groups: (1) gemigliptin 50 mg qd + metformin 1000 to 2000 mg qd (titrated individually), (2) gemigliptin 50 mg qd, or (3) metformin 1000 to 2000 mg qd. The primary end‐point was the change in  HbA1c  level after 24 weeks. Secondary end‐points were the changes in  FPG , insulin, proinsulin and C‐peptide levels. The percentages of responders who achieved an  HbA1c  level <7% (or <6.5%) were compared between treatment groups.    Results  Baseline  HbA1c  levels were 8.7% in all groups. The mean changes in  HbA1c  level from baseline to week 24 were −2.06%, −1.24% and −1.47% in the combination, gemigliptin monotherapy and metformin monotherapy groups, respectively. The 95% confidence intervals for between‐group differences in  HbA1c  changes were −1.02 to −0.63 in the combination group vs the gemigliptin group and −0.82 to −0.41 vs the metformin group, which confirmed the superiority of combination therapy. A significantly higher percentage of patients in the combination therapy group reached the target  HbA1c  level <7% (or <6.5%) compared with the monotherapy groups. No severe side effects were observed.    Conclusions  In  T2D  patients, the initial combination of gemigliptin and metformin had superior efficacy without safety concerns compared with monotherapy with either drug.

diabetes, obesity and metabolism

Efficacy and safety of initial combination therapy with gemigliptin and metformin compared with monotherapy with either drug in patients with type 2 diabetes: A double‐blind randomized controlled trial ( INICOM  study)