Type 2 diabetes mellitus
Conditions
Sponsors
Dokkyo Medical University Nikko Medical Center Department of Clinical Study Support Center
Department of Cardiovascular Medicine,Nephrology and Neurology,University of the Ryukyus. Yokokawa Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (a) 20 to 75 years of age at informed consent (b) Type 2 diabetes mellitus patient, with HbA1c>7.0% (c) Diabetic nephropathy stage <=3 (d) Patients visiting the hospital on an outpatient basis for diabetic therapy, who provide written informed consent
Exclusion criteria
Exclusion criteria: (a) Patients with type 1 diabetes mellitus (b) Patients with a medical history of hypersensitivity to any of the ingredients of dapagliflozin (c) Patients with severe ketosis or diabetic coma or pre-coma (d) Patients who have severe infection, are pre- or postoperative, or have sustained serious trauma (e) Patients with severe impaired liver function (f) Patients who are susceptible to dehydration (g) Patients with urinary tract infection or genital infection (h) Patients with a history of cerebrovascular disease within the last 3 months (i) Women who are pregnant or breastfeeding or who may be pregnant (j) Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 mL (k) Patients on warfarin or a novel oral anticoagulant (NOAC) (dabigatran, rivaroxaban, edoxaban, or apixaban) (l) Current smokers (m) Patients otherwise deemed to be unsuitable for the clinical study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whole blood transit time (0.1 mL) and the difference from baseline at 16 weeks after enrollment, as assessed using the microchannel array flow analyzer (MC-FAN) equipped with BK 7-7-7D chip | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood samples at 8 and 16 weeks after enrollment (whole blood transit time (0.1 mL) and difference from baseline as determined using the MC-FAN with DKAMCM1-60-7-4.5D, leukocyte activation (adhesive leukocyte count as determined using the MC-FAN with DKAMCM1-60-7-4.5D , difference between whole blood transit time in heparin (5% vol) blood samples and whole blood transit time in EDTA-2Na + heparin blood samples as determined using the DKAMCM1-60-7-4.5D), CBC, lipid system, hsCRP, serum creatinine, hydroperoxide levels as serum levels of reactive oxygen metabolite (d-ROM) and antioxidant potencial as determined by BAP test using F.R.E.E. carpe diem (Diacron srl, Grosseto, Italy) and urine samples (albuminuria assay); whole blood transit time (0.1 mL) and difference from baseline as determined using the MC-FAN 7-7-7D chip at 8 weeks after enrollment; and percentage in which whole blood transit time (0.1 mL) did not increase =>6.0sec(15%), as determined using MC-FAN at 8 and 16 weeks after enrollment | — |
Countries
Japan
Contacts
Public ContactAkiko Niijima
Dokkyo Medical University Nikko Medical Center Clinical Study Support Center
Outcome results
None listed