FAGOTTO study

JRCT ID: jRCTs041200069

Registered date:27/11/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diabetes Mellitus, Type 2
• Date of first enrollment: 23/12/2020
• Target sample size: 110
• Study type: Interventional

Intervention(s)

am A ; CANAGLU tablet 100mg /day
am B ; control

Outcome(s)

• Primary Outcome: Rate of change in FF (filtration fraction) after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group

Secondary Outcome

-Change in FF after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group
-Rate of change and change in Cin (glomerular filtration rate by inulin) after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group
-Rate of change and change in RPR (renal plasma flow) after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group
-Rate of change and change in RBR (renal blood flow) after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group
-Rate of change and change in RVR (renal vascular resistance) after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group
-Change in eGFR, HbA1c and albuminuria (proteinuria) after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group
-Change in blood pressure and body weight after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group
-Change in urinary angiotensinogen after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group
-Change in urinary MCP-1, NAG, beta2MG, L-FABP after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group
-Change in serum erythropoietin and hematocrit after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group
-Change in serum vasopressin (instead of copeptin), renin, aldosterone, and sodium after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-patients with stable type 2 diabetes
-eGFR(Crteatinine)<= 60mL/min/1.73m2
-patients who are taking renin angiotensin system inhibitors (exclude intolerable or non-adaptive)
-older than 18 years
-written consent

Exclude criteria

-SGLT2 inhibitors users within 8 weeks
-30<eGFR(Crteatinine) mL/min/1.73m2
-under maintenance dialysis therapy or history of kidney plantation
-diuretics users
-patients who are taking both ACEi and ARB (renin inhibitor)
-active nephritis or kidney disease
-obvious steroid diabetes
-patients whose ALT and AST levels exceed 2.0 times the facility standard value
-heart failure NYHA class 4
-pregnant, or desiring to bear children
-inapporopriate for this study as judged by attending investigateor

Related Information

• Primary Sponsor: Maruyama Shoichi
• Source(s) of Monetary Support: Mitsubishi Tanabe Pharma Corporation