1163-P: Comparison of Glycemic Variability between Gemigliptin and Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Randomized, Active-Controlled, Multicenter, 12-Week Clinical Trial (STABLE II Study)

Abstract

The aim of this study was to evaluate the effect of gemigliptin, a potent and selective dipeptidyl peptidase-4 inhibitor versus dapagliflozin, a sodium glucose co-transporter-2 inhibitor on glycemic variability in patients with type 2 diabetes mellitus (T2DM). This randomized, parallel group, blinded end-point, multicenter, 12-week clinical trial was conducted in 71 patients with T2DM inadequately controlled with metformin alone or drug naïve patients. Subjects were randomized to receive gemigliptin 50mg (N=35) or dapagliflozin 10mg (N=36) daily for 12 weeks. Glycemic variability parameters such as mean amplitude of glycemic excursions (MAGE), standard deviation (SD) and coefficient of variation (CV) were evaluated during 6-day continuous glucose monitoring at baseline and after 12 weeks of treatment. The primary efficacy endpoint was change in MAGE after 12 weeks compared to baseline. Measures of glycemic control, oxidative stress and inflammation, as well as safety profiles were assessed. Adjusted mean change ± standard error in MAGE after 12 weeks were -27.2 ± 4.4 mg/dL (P<0.001) in the gemigliptin group and -7.9 ± 4.9 mg/dL (P=0.160) in the dapagliflozin group. The between-group comparison showed that gemigliptin group had significantly larger reduction in MAGE compared to dapagliflozin group (-19.2 mg/dL, 95% CI -31.3 to -7.2, P=0.002). Other glycemic variability parameters including SD and CV also showed significantly larger reduction in the gemigliptin group. Glycemic control estimated by HbA1c, fasting glucose and safety profiles were comparable between the two groups. In conclusion, gemigliptin significantly improved glycemic variability than dapagliflozin with similar glycemic efficacy and safety profiles in patients with T2DM inadequately controlled with metformin alone or drug naïve patients. ClinicalTrials.gov Identifier: NCT03202563. Disclosure Y. Hwang: None. J. Kim: None. S. Kwak: None. S. Kim: None. J. Won: None. J. Bae: None. H. Kim: None. S. Suh: None. E. Lee: None. S. Lee: Employee; Self; LG Chem. Funding LG Chem, Ltd.