type 2 diabetes mellitus
Conditions
Interventions
The group which Empagliflozin 10mg every day for 12 weeks or 24 weeks.
The group which takes Empagliflozin 10mg only when a patient thinks it to be necessary at the maximum 14 times a month for 12 wee
Sponsors
Toho University School of Medicine, Division of diabetes, metabolism and endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Type 2 diabetes patients controlled inadequately with 7.0 to 9.9%. (2)Patient taking equal or less than three kinds of oral anti-diabete drugs in addition to diet and exercise therapy for 12 weeks or more. (3)Patients who does not use human GLP-1 analog or insulin. (4)Adalts who are 20 years or older and 75 years or younger. (5)Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in examination.
Exclusion criteria
Exclusion criteria: (1) Type 1 diabetes mellitus patients or secondary diabetic mellitus. (2) Patients who had myocardial infarction within 3 months, or obvious heart failure case. (3) Patients who had the past hypersensitivity for the used drug. (4) Patients with diabetic ketoacidosis or diabetic coma or risk of diabetic coma. (5) Patients with severe liver disease. (6) Patients with severe renal disease. (7) Patients with severe pancreas disease. (8) Patients with hemoglobin (Hb) less than 11 g/dL. (9) Patient during cancer treatment (10) Patients that the number of the platelets is less than 100,000 /mm3. (11) Patients with severe diabetic neuropathy. (12) Patients having a proliferative retinopathy. (13) Patients with a serious infectious disease or a serious injury. (14) Excessive common custom drinker (15) A pregnant woman or the woman who may be pregnant. (16) In addition, the patients who will be judged inappropriate by an attendant physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.a reduction degree of the HbA1c and fasting plasma glucose 12 or 24 weeks later | — |
Secondary
| Measure | Time frame |
|---|---|
| 2.changes of dietary intake 12 or 24 weeks later 3.changes of quality of life(QOL) 12 or 24 weeks later 4.a reduction degree of lipid parameters(HDL cholesterol?LDL cholesterol?triglyceride) and albumin in urine 12 or 24 weeks later 5.changes of body weight,blood pressure, and abdominal circumscription 12 or 24 weeks later | — |
Countries
Japan
Outcome results
None listed