Type 2 diabetes
Conditions
Interventions
Orally administration of 5mg dapagliflozin(usual dose) once a day for 24 weeks
Dapagliflozin non-administration group (continuation of conventional therapy group)
Sponsors
Saitama Medical University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Aged from 20 less than 65 years at providing consent which is obtained in writing by voluntary 2)Patients with type 2 diabetes with BMI 24 kg/m2 or more 3)HbA1c(NGSP value) was from 7% to less than 10% for 3 months or more under convetional treatment (HbA1c>=7.5% in the case of SU agent or glinides drug users)
Exclusion criteria
Exclusion criteria: Patients 1)with receiving SGLT2 inhibitor, insulin, either GLP-1 receptor agonists 2)with obvious ischemic heart disease (angina pectoris, myocardial infarction), a history of ischemic cerebrovascular disease 3)male:serum Cr>=1.2 mg/dL woman:serum Cr>=1.0 mg/dL 4)fasting serum triglyceride is greater than or equal to 400 mg/dL 5)HbA1c was changed more than 2% within 3 months 6)with unconscious thirst (impossible self-judgement enough water intake) 7)with contraindication for dapagliflozin a)with a history of hypersensitivity to dapagliflozin b)Severe ketosis, diabetic coma or precoma c)Severe infection, before and after surgery, patients with severe trauma 8)Cosidered as inadequated by the investigator and doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Improvement effect of sd-LDL and IDL and LDL, HDL using by Lipopho AS 2) Improvement effect of lipid general profile(TC, TG, HDL-C, LDL-C, LDL/HDL-C ratio, non HDL-C) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Lowering effect of body weight, blood pressure 2) Improvement effect of hs-CRP, HOMA-beta, and HOMA-IR 3) Lowering effect of HbA1c | — |
Countries
Japan
Contacts
Public ContactIkuo Inoue
Saitama Medical University Hospital Department of Endocrinology and Diabetes
Outcome results
None listed