Table 1.

Trial schedule of data collection

	Screening		Treatment (TD, treatment day)				Follow-up
	Visit 1	Visit 2	Visit 3	Visit 4	Visit 5	Visit 6	Visit 7
	(Max −12 weeks to TD1)	(1–2 weeks prior to TD1)	(Week 12)	(Week 24)	(Week 36)	(1–7 days + week 48/EOT)	(12 weeks after EOT)
Informed consent	X
Clinical assessmenta	X	X	X	X	X	X	X
Vital signsb	X	X	X	X	X	X	X
Screening blood testc	X		X	X	X	X	X
Liver biopsy	X					X
Genes of the liver and blood cells	X					X
Transient elastography	X		X			X
Study medicationd	X	X	X	X	X	X	X
Adverse/clinical events			X	X	X	X	X
Bioelectrical impedance		X	X	X	X	X	X
Standard blood and urine teste		X	X	X	X	X	X
Oxidative stress markers, cytokine		X				X
Hepatokines		X				X
Micro RNAs and exosome contents		X				X
Arginine stimulation test		X				X
Euglycemic hyperinsulinemic clamp study with stable isotopes		X				X
Respiratory quotient and basal energy expenditure		X				X
Proton magnetic resonance spectroscopy		X				X
Cardiac autonomic nerve activity		X				X
EndoPAT		X				X
Treatment satisfaction questionnaire		X				X
Feces		X				X

TD1 treatment day 1, EOT end of treatment, EndoPAT peripheral arterial tone test

^aClinical assessment: complete history/examination, physical and mental conditions

^bVital signs: blood pressure, heart rate, weight, height, waist and hip circumferences

^cScreening blood test: fasting plasma glucose, HbA1c

^dStudy medication: If the study patient meets the eligibility criteria, he/she will be randomized at TD1 to receive tofogliflozin or sulfonylurea

^eStandard blood and urine test: fill blood count, renal function, electrolytes, lipid profile