Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress

JRCT ID: jRCTs071180044

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 26/04/2017
• Target sample size: 90
• Study type: Interventional

Intervention(s)

Dapagliflozin treatment group: Oral dapagliflozin 5 mg/day in combination with standard therapy (the dapagliflozin dose can be increased to 10 mg in subjects with inadequate response to 5 mg)
Non-dapagliflozin treatment group: Optimal diabetes treatment other than an SGLT2 inhibitor in combination with standard therapy

Outcome(s)

Primary Outcome

Whole blood transit time (0.1 mL) and the difference from baseline at 16 weeks after enrollment, as assessed using microchannel array flow analyzer (MC-FAN) equipped with BK 7-7-7D chip
Assessment method of primary outcome: Six sec (15%) noninferiority margin (clinically significant cut-off value) will be used. The 95% confidence interval of the difference from baseline will be calculated using the t-distribution to test noninferiority.

• Secondary Outcome: 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), 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 (0.1mL) did not increase 6.0sec(15%) as determined using MC-FAN at 8 and 16 weeks after enrolment.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both
• Include criteria: Type 2 diabetes mellitus patient, with HbA1c>7.0%, Diabetic nephropathy stage <=3

Exclude criteria

Patients with type 1 diabetes mellitus
Patients with a medical history of hypersensitivity to any of the ingredients of dapagliflozin

Related Information

• Primary Sponsor: Yasu Takanori
• Source(s) of Monetary Support: AstraZeneca K.K.(AstraZeneca/MedImmune Externally Sponsored Scientific Research Operations System ),Ono Pharmaceutical CO.LTD.