diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Department of Endocrinology and Diabetes Saitama Medical Center, Saitama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects should be type 2 diabetic patients who have stable glycemic control for more than 2 months, and their HbA1c should be less than 8.0 %. Subjects who are taking pioglitazone or metformin or DPP-4 inhibitors will be also enrolled.
Exclusion criteria
Exclusion criteria: 1) Under the treatment with insulin 2) Type 1 diabetic subjects or diabetic subjects who have HbA1c more than or equal to 8.0 % or who need admission because of diabetic ketoacidosis or extreme hyperglycemia. 3) Subjects who are treated with sulfonylureas (i.e. glibenclamide, glimepiride, or gliclazide). 4) Subjects with nephrotic syndrome (urine protein more than or equal to 3.5g/day and serum protein less than or equal to 6.0 g/dl [or serum albumin less than or equal to 3.0 g/dl]. 5) Subjects who are taking steroids, immune suppression medication, antifungal medication of azoles. HIV protease inhibitors 6) Subjects who had brain stroke or acute coronary syndrome within 6 months before enrollment. 7) Subjects with severe heart failure (NYHA class 3 or higher), severe arrhythmia (frequent atrial or ventral arrhythmia, continuous ventricular tachycardia, severe atrial tachycardia, atrial fibrillation or flutter with severe tachycardia, sick sinus syndrome or atrial-ventral block with severe bradycardia). 8) Subjects who have AST or ALT more than 5 times of upper normal limit of their institute 9) Subjects with malignancy 10) Subjects who are pregnant or who have intention to be pregnant 11) Subjects with other situations under which a doctor in charge decides that subjects are not eligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of muscle insulin sensitivity and liver insulin resistance (should be consistant to the effect of SGLT-2 inhibitors, when compared with previous studies) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Exsitence of difference between the new indices and HOMA-IR or Matsuda index without considering urine glucose excretion 2)Consistence of beta cell function measured by HOMA-beta or insulinogenic inex 3)Any changes in the disposition index 4)Existance of urinary glucose excretion after terminatio of SGLT-2 inhibitors | — |
Countries
Japan
Contacts
Public ContactMasafumi Matsuda
Saitama Medical Center, Saitama Medical University Department of Endocrinology and Diabetes
Outcome results
None listed