Phase 3 Trial to Evaluate Efficacy and Safety of Gemigliptin and Dapagliflozin Dual Add-on Therapy to Metformin-SOLUTION 2 Study

Background: Type 2 diabetes mellitus (T2DM) patients inadequately controlled with metformin alone require an addition of other medications with complementary mechanism of action. Gemigliptin, a dipeptidyl peptidase-4 inhibitor, and Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, can be considered as additional options. In this clinical trial, efficacy and safety of treatment of gemigliptin and dapagliflozin were evaluated in T2DM patients inadequately controlled with metformin monotherapy. Method: Total 469 T2DM patients receiving treatment with stable metformin for ≥ 8 weeks before screening were randomized to gemigliptin and dapagliflozin (n=157) or gemigliptin (n =156) or dapagliflozin (n =156), respectively. The primary endpoint was the change in HbA1c at 24 weeks from baseline. Results: At 24-week treatment, the HbA1c change from baseline in dual add-on of gemigliptin and dapagliflozin showed a significant reduction (LS Mean -1.34%) compared to gemigliptin add on (-0.90%; difference -0.44% [95% CI -0.58% to -0.31%]) and dapagliflozin add on (-0.78%; difference -0.56% [95% CI -0.69% to -0.42%]). Most of the reported adverse events were mild with no episodes of severe hypoglycemia. Conclusion: This study demonstrated that triple therapy of gemigliptin and dapagliflozin dual add-on to metformin was effective and well tolerated in T2DM patients. Disclosure K. Park: None. K. Han: None. Y. Hwang: None. S. Moon: None. H. Cho: None. H. Yoo: None. S. Choi: None. S. Chon: None. K. Kim: None. T. Kim: None. J. Kang: None. C. Park: None. J. Won: None. S. Lee: Advisory Panel; LG Chem. Speaker's Bureau; Dong-A Pharm. Advisory Panel; CKD Pharm. Speaker's Bureau; Novo Nordisk, Lilly. Advisory Panel; Daiichi Sankyo. Speaker's Bureau; Boehringer Ingelheim Inc. N. Kim: None. E. Kang: None. D. Kim: None. S. Kim: None.