Table 6.

Changes in safety and research blood parameters after 12 months dapagliflozin treatment

Variable	Intention-to-treat analysis
	Dapagliflozin	Placebo	Differencea	P-value
	(n = 32)	(n = 34)	(95%CI)
Haemoglobin (g/L)	7.00 ± 11.75	−2.00 ± 5.00	9.51 (5.85 to 13.18)	<0.001
Haematocrit (%)	2.60 ± 0.02	0.30 ± 0.02	2.90 (1.84 to 3.96)	<0.001
Creatinine (umol/L)	1.34 ± 5.89	−0.91 ± 5.83	2.26 (−0.63 to 5.14)	0.123
cGFR (mL/min/1.732)	−1.16 ± 10.48	1.59 ± 7.19	−2.74 (−7.14 to 1.65)	0.217
Sodium (mmol/lL)	−0.75 ± 2.05	0.38 ± 1.83	−1.13 (−2.09 to 0.18)	0.121
Potassium (mmol/L)	−0.03 ± 0.26	−0.04 ± 0.30	−0.01 (−0.12 to 0.15)	0.852
Fasting glucose (mmol/L)	−1.06 ± 2.08	0.62 ± 2.11	−1.68 (−2.71 to −0.65)	0.002
HbA1c (mmol/mol)	−6.28 ± 8.25	−0.79 ± 10.89	−5.49 (−10.26 to −0.71)	0.025
NT-proBNP (pg/mL)b	7.14 ± 138.69	40.19 ± 219.47	−103.68 (−326.90 to 119.54)	0.551
Leptin (pg/mL)b	−447.55 ± 5299.58	477.6 ± 6314.88	−2931.7 (−6901.46 to 1038.07)	0.256
Myeloperoxidase (ng/mL)b	0.00 ± 107.04	−36.49 ± 85.63	23.02 (−31.05 to 77.08)	0.172
NT-pro collagen III (ng/mL)	−0.44 ± 5.06	−0.1 ± 4.24	−0.46 (−2.20 to 1.29)	0.653
hsCRP (ng/L)b	−163.73 ± 1040.76	66.73 ± 1258.37	−1296.04 (−2650.59 to −31.50)	0.049
Fasting insulin (uU/mL) (n = 48)b,c	−2.34 ± 5.59	−0.58 ± 7.14	−3.61 (−6.97 to −0.26)	0.098
	(n = 22)	(n = 26)
HOMA-IR (n = 48)b,c	−2.1 ± 2.37 (n = 22)	0.46 ± 3.23 (n = 26)	−2.56 (−4.47 to −0.65)	0.017

P-values in bold indicate <0.05.

eGFR, estimated glomerular filtration rate; HDL, high-density lipoprotein; HOMA-IR, homeostatic model assessment of insulin resistance; hsCRP, high sensitive C-reactive protein; LDL, low-density lipoprotein; NT-proBNP, N-terminal pro natriuretic B-type natriuretic peptide.

^aAbsolute mean difference between groups. All other values expressed in mean ± SD unless stated.

^bMedian ± IQR.

^cOnly performed on the participants not on insulin.