Type 2 Diabetes Mellitus
Conditions
Interventions
Group A- Ipraglifrojin group (n=100)
50mg/day of ipraglifrojin would be administered, and the blood sample was prepared at the start, 1, 3 and 6 months after the treatment. The dose up to 100mg/day would be permitted as the doctors'
judgement after 3 months treatment. In the case with hypoglycemia, the drug dose should be decreased as the Doctors'
judgement. The other drug would be added by the doctors'
judgement.
Group B-As control sitagliptiin group (n=100)
Sponsors
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The type 2 diabetic patients under the not-well dlycemic control even if the diet/excise therapy was addressed more than 1 month. The HbA1c levels (7-10.5%) would be stable within 1% during the observation term, 2 months. The eGFR would be maintainedover than 45mL/min. BMI over than 20. The signature of each patient should be obtained after the written informed consent.
Exclusion criteria
Exclusion criteria: Type 1 diabetes. The treatment with insulin, GLP-1, DPP4 inhibitors, SGLT2 inhibitors, hypolipidemic agents, diuretics, steroids, or immunosuppressants. The past history of severe ketosis, diabetic pre-coma and coma. The cases complicated with proliferative retinopathy, dysuria, infectious diseases of urinary tract or genitals, severe infectious diseases, perioperative period, severe trauma, pregnant or the chance of pregnancy, lactational phase, severe liver disorder (Child-Pugh Grade Score 10-15), cerebral vascular diseases/unstable angina/myocardial infarction/angioplasty within 6 months, or the past history of severe heart diseases (NYHA Class III-IV). The patients were judged as the inappropriate cases for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes of lipids metabolism marker (apolipoproteins including apo B48, AI, AII, B, CII, CIII, E), serum lipids, and the markers of cholesterol synthesis (lathosterol) and aborption (campesterol, sitosterol, and cholestanol) would be compared between SGLT2 inhibitor and DPP4 inhibitor treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of body weight and BMI. The changes of glucose control; HbA1c, fasting blood glucose, glycoalbumin (GA), serum insulin). Miscellaneous; serum ketones, liver function (AST, ALT, ganmma GTP, LDH), electrolytes (Na, K, CL), urate, creatini kinase, sistatin C, fatty acids (EPA and arachidonic acid), complement, and urinary albumn-to-creatinin ratio, leptin, and the peripheral blood cell counts. The comparison in the frequensy of the cases controled under the target level os HbA1c (<7.0%), and of the cases added with the other agents to get a good control, and of the cases with body weight reduction. | — |
Countries
Japan
Contacts
Public ContactShinichi Oikawa
Fukujuji Hospital, Japan Anti-Tuberculosis Association Diabetes-Lifestyle Disease Center
Outcome results
None listed