Type 2 diabetes mellitus with Heart failure Type 2 diabetes mellitus,Heart failure
Conditions
Interventions
Tofogliflozin at a dose of 20 mg orally once daily before or after breakfast for 24 weeks.
Sponsors
Murohara Toyoaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Aged >=20 years 2.Diagnosis of type 2 diabetes mellitus and HbA1c of >= 6.5% and == 125 pg/mL or patients with atrial fibrillation and NT-proBNP >= 365 pg/mL within 12 weeks prior to informed consent 6.eGFR >= 30mL/min/1.73m^2 within 12 weeks prior to informedconsent 7.Signed and dated informed consent
Exclusion criteria
Exclusion criteria: 1.Receiving therapy with a SGLT2 inhibitor within 8 weeks prior to informed consent 2.Receiving therapy with an insulin within 8 weeks prior to informed consent 3.Change in drugs or dosage within 4 weeks prior to informed consent 4.Sympomatic hypotension or systolic blood pressure < 95mmHg 5.History of hospitalization for acute heart failure or heart failure within 4 weeks prior to informed consent 6.History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to informed consent 7.History of PCI, CABG, valvular repair/replacement within 12 weeks prior to informed consent or with plans 8.History of Pacemaker implantation within 12 weeks prior to informed consent or plans 9.Previous cardiac transplantation or with plans 10.Restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic cardiomyopathy or valvular disease 11.Symptomatic bradycardia 12.Known hypersensitivity to iodine hypersensitivity 13.Receiving therapy with Reserpine,Tricyclic Antidepressants,labetalol 14.Parkinsons disease 15.Malignant tumor in need of treatment 16.Indication of liver disease, defined by serum levels of either ALT, AST above 3 times upper limit of normal, or total bilirubin above 2 times upper limit of normal 17.Severe impaired renal function, defined as eGFR < 30 mL/min/1.73m^2 18.BMI < 18.5 kg/m^2 19.Breastfeeding, pregnant or intent to be pregnant 20.Severe ketosis, diabetic coma or precoma 21.Severe infection, preioperative or serious trauma 22.Known hypersensitivity to tofogliflozin 23.Inappropriate condition for this clinical trial based on the investigators clinical judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the following indicators of I-123 MIBG scintigraphy at 24 weeks after administration of tofogliflozin from baseline (comparison before and after administration) Late H / M ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| Important secondary evaluation items Change in the following indicators of I-123 MIBG scintigraphy at 24 weeks after administration of tofogliflozin from baseline (comparison before and after administration)Change of following parameters (Time frame:0 to 24 weeks, before and after) WR (washout rate) Early H / M ratio Secondary evaluation item Amount of change in various indicators from baseline to 24 weeks after administration of tofogliflozin (comparison before and after administration, rate of change for lipid system) Correlation between the amount of change in various indicators (rate of change for lipid system) at 24 weeks after administration of tofogliflozin frombaseline Vital:height, weight, BMI, body composition (body fat mass, body fat percentage, lean body mass,muscle mass, body water content, basal metabolicrate), blood pressure (SBP / DBP), heart rate electrocardiogram parameters, chest radiographic finding Echocardiography:GLS, LV end-diastolic diameter, LV end-systolic diameter,LA volume, LV volume, LV mass, DcT, LVEF, E / A, e, E / e, E wave, A wave, TRPG, IVC diameter, right atrial pressure (estimated) Carbohydrate system:HbA1c, fasting blood glucose, fasting insulin, HOMA-IR, pancreatic glucagon, active GLP-1, active GIP Lipid system:TC, LDL-C (calculation formula), LDLC(direct method), TG, HDL-C, Lp (a), sdLDL, ApoB, ApoA1, ApoA2 Blood system:WBC,RBC,Platelets,Ht,Hb,MCV (calculation formula), MCH (calculation formula), MCHC (calculation formula),EPO,troponinT Kidney system:eGFR,serum creatinine,Urine albumin / creatinine ratio,UA,BUN,urinary NGAL Liver system:AST,ALT,ALP,gamma-GTP Others:total ketone body, ketone body fraction,hsCRP,8-OHdG, aldosterone / renin activity ratio, dopamine, noradrenaline, adrenaline, NT-proBNP, adiponectin, stem cells (CD34 positive cells) safety:number and rate of adverse events, number and rate of diseases | — |
Contacts
Public ContactToyoaki Murohara
Nagoya University Hospital
Outcome results
None listed