The investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus whose HbA1c levels are less than 7.0% (from 20 to 65 years of age). The investigators will examine changes of fasting lipoprotein profile including TG, TC, HDL-C, apoB-48 and RemL-C before and after the 8 weeks administration of dapagliflozin.
In this study, the investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus. Primary Objective is to examine changes of fasting lipoprotein profile by the administration of dapagliflozin; Concentrations of apoB-48 and RemL-C. Secondary Objectives are; to examine changes of fasting glucose and HbA1c (NGSP) level by the administration of dapagliflozin, to examine changes of fasting lipid profile by the administration of dapagliflozin; Concentrations of TG, TC, HDL-C and LDL-C, to examine changes of fractions of free fatty acids, protein mass of LPL, and lipoprotein profile assessed by the HPLC by the administration of dapagliflozin, to examine changes of biomarkers for renal and hepatic function by the administration of dapagliflozin, and to examine the frequency of adverse effects by the administration of dapagliflozin. This study is open-label study and contains patients who are diabetes mellitus of from 20 to 65 years of age and their Patients who have not achieve the clinical target of the glycemic control (less than 7.0% in HbA1c).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Dapagliflozin is orally administered for 8 weeks in the dose of 5mg per day by adding the conventional treatment if there is no serious event included in termination criteria. If the effect for improving diabetes is insufficient, it is allowed to raise its dose up to 10mg/day.
Sousei Hospital
Kadoma, Osaka, Japan
Osaka Central Hospital
Osaka, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Changes in fasting lipoprotein profiles
Changes in fasting lipoprotein profiles including concentrations of apoA-1, apoA-2, apoB, apoB-48, apoC-2, apoC-3, apoE, RemL-C, free-fatty acids profile, LPL protein mass and lipoprotein profile assessed by the HPLC at four and eight weeks after the administration of dapagliflozin
Time frame: at four and eight weeks after the administration of dapagliflozin
Changes in fasting lipid profiles
Changes in fasting lipid profiles including concentrations of triglyceride(TG), total cholesterol(TC), HDL-cholesterol (HDL-C) and LDL-C at four and eight weeks after the administration of dapagliflozin
Time frame: at four and eight weeks after the administration of dapagliflozin
Changes in fasting blood glucose and HbA1c
Changes in fasting blood glucose and HbA1c at four and eight weeks after the administration of dapagliflozin
Time frame: at four and eight weeks after the administration of dapagliflozin
Changes in insulin and adiponectin
Changes in other clinical profiles including concentrations of insulin and adiponectin
Time frame: at four and eight weeks after the administration of dapagliflozin
Frequency of adverse side effects
Frequency of adverse side effects at four and eight weeks after the administration of dapagliflozin
Time frame: at four and eight weeks after the administration of dapagliflozin
Changes in biomarkers for renal and hepatic function
Changes in biomarkers for renal and hepatic function at four and eight weeks after the administration of dapagliflozin.
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Time frame: four and eight weeks after the administration of dapagliflozin.