Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study

Table 4 Changes in fasting serum lipids and ketone bodies at day 29

	Placebo (n = 20)	Empagliflozin 10 mg (n = 20)	Empagliflozin 25 mg (n = 19)
Total cholesterol, mg/dl
Baseline	212.8 (7.7)	200.1 (8.4)	208.7 (9.1)
Change from baseline at day 29	−0.8 (3.6)	3.2 (3.7)	1.1 (3.7)
Difference vs placebo (95% CI)		4.0 (−6.6, 14.6)	1.9 (−8.6, 12.3)
p-value		0.455	0.722
HDL-cholesterol, mg/dl
Baseline	46.8 (2.2)	47.6 (2.8)	46.8 (2.8)
Change from baseline at day 29	0.1 (1.2)	4.7 (1.3)	7.4 (1.3)
Difference vs placebo (95% CI)		4.5 (1.0, 8.1)	7.2 (3.7, 10.8)
p-value		0.014	<0.001
LDL-cholesterol, mg/dl
Baseline	128.7 (6.3)	124.9 (8.4)	130.5 (8.5)
Change from baseline at day 29	−1.3 (3.2)	3.4 (3.3)	4.3 (3.3)
Difference vs placebo (95% CI)		4.7 (−4.6, 14.0)	5.7 (−3.5, 14.8)
p-value		0.314	0.221
Triglycerides, mg/dl*
Baseline	159.6 (51.0)	131.5 (34.9)	142.2 (48.0)
Relative change from baseline at day 29	1.0 (0.9, 1.1)	0.8 (0.7, 0.9)	0.7 (0.6, 0.8)
Difference vs placebo (95% CI)		0.8 (0.7, 1.0)	0.7 (0.6, 0.8)
p-value		0.037	<0.001
Free fatty acids, mg/dl
Baseline	10.8 (0.8)	9.6 (0.7)	9.3 (0.6)
Change from baseline at day 29	3.1 (0.8)	4.8 (0.8)	7.4 (0.8)
Difference vs placebo (95% CI)		1.7 (−0.6, 4.1)	4.3 (2.0, 6.7)
p-value		0.149	<0.001
Ketone bodies, μmol/l
Baseline	86.8 (10.2)	78.1 (12.0)	69.4 (10.8)
Change from baseline at day 29	−12.2 (44.0)	139.5 (44.7)	408.0 (45.5)
Difference vs placebo (95% CI)		151.7 (24.4, 279.0)	420.2 (293.3, 547.2)
p-value		0.021	<0.001

Unless otherwise indicated, baseline data are mean (standard error [SE]), change from baseline data are adjusted mean (SE) based on analysis of covariance (ANCOVA) in the treated set. Fasting measurements. *Log-transformed data; baseline data are gMean (%CV) and change from baseline data are adjusted gMean ratio (95% CI).

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