Type 2 Diabetes Mellitus
Conditions
Interventions
None listed
Sponsors
Naka Kinen Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants in the study must have insufficient glycemic control under diet and exercise and/or treatment with hypoglycemic drugs other than SGLT2 inhibitors. Patients will be considered eligible for the study if they fulfil all the inclusion criteria and none of the exclusion criteria as defined below. 1.Patients providing written informed consent to participate in the study 2.Aged >=60 years (irrespective of sex) 3.HbA1c level >6.5, <10.0 mg/dL within 8 weeks before consent (patient receiving insulin, sulfonylureas or glinides: >=7.0%) 4.eGFR level >30, <60 mL/min/1.73m2 before consent 5.anemia of chronic kidney disease defined as hemoglobin < 12.0 g/dL without iron deficiency defined as serum ferritin levels > 50 ng/mL before consent 6.patients who have not change dosage and administration of drugs for hypoglycemic drugs, ESA, and iron from at least 8 weeks before the date of consent
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes 2.Patients with severe ketosis, diabetic coma or pre-coma, severe infection, perioperative, or severe trauma 3.Patients with severe renal dysfunction or treated with hemodialysis for end-stage renal disease 4.History of acute coronary syndrome, cerebrovascular disease, myocarditis, contractile pericarditis, or severe valvular disease within 12 weeks before consent 5.NYHA cardiac function classification of IV 6.BMI <18.5 kg/m2 7.Pregnant, breast-feeding, or possibly pregnant women 8.Diagnosed or suspected malignant tumors (patients who do not have a treatment history of anticancer therapy within 1 year before consent, and have no plan to do so will not be excluded) 9.Patients in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of parameters of the erythropoiesis (RBCs, Hb, Hct, CHr, EPO, MCV) and iron homeostasis (ferritin, TSAT, hepcidin) at 12 weeks after dapagliflozin administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of several parameters at 12 weeks after dapagliflozin administration 1.BIA and body composition analysis 2.HbA1c and BMI 3.Uric acid, Cre, eGFR, UACR, and urine sodium 4.AST, ALT, and gamma-GTP 5.Total, HDL, and LDL cholesterol, and TG 6.Severe adverse events | — |
Countries
Japan
Contacts
Public ContactKensuke Ofuchi
Naka Kinen Clinic Clinical Labratory
Outcome results
None listed