Abstract
AIMS: Our purpose was to clarify the predictive clinical characteristics of add-on therapy using dapagliflozin in patients with type 2 diabetes mellitus. METHODS: This single-center, open-label, pilot study was conducted in 50 patients with type 2 diabetes mellitus. They were treated with 50 mg dapagliflozin, once daily. A total of 46 patients were successfully followed over 12 weeks of treatment with dapagliflozin. They were assessed for several clinical parameters before the start of the study and at 12 weeks. Multiple linear regression analysis was used to search for independent predictors of reduction of hemoglobin A1c (HbA1c) levels after 12 weeks of dapagliflozin add-on treatment (ΔHbA1c). RESULTS: Dapagliflozin administration for 12 weeks resulted in significant reductions in baseline body mass index, systolic blood pressure, fasting plasma glucose, HbA1c, alanine aminotransferase, and uric acid. We were also able to show that HbA1c levels and low-density lipoprotein cholesterol (LDL-C) significantly correlated with ΔHbA1c. Furthermore, multiple linear regression analysis showed that baseline HbA1c and LDL-C significantly correlated with ΔHbA1c. CONCLUSION: Our prospective 12-week study showed that baseline HbA1c and LDL-C significantly contribute to the HbA1c-lowering effect of dapagliflozin. TRIAL REGISTRATION: UMIN Clinical Trials Registry (UMIN000014922).