Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naïve patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial

Roden, Michael; Merker, Ludwig; Christiansen, Anita Vedel; Roux, Flavien; Salsali, Afshin; Kim, Gabriel; Stella, Peter; Woerle, Hans J.; Broedl, Uli C.

doi:10.1186/s12933-015-0314-0

Table 4 Lipid parameters

From: Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naïve patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial

	Placebo		Empagliflozin 10 mg		Empagliflozin 25 mg		Sitagliptin 100 mg
	Baseline	Change from baseline at week 76	Baseline	Change from baseline at week 76	Baseline	Change from baseline at week 76	Baseline	Change from baseline at week 76
Total cholesterol (mmol/l)	5.03 ± 0.08	−0.03 ± 0.05	5.00 ± 0.08	0.10 ± 0.05	5.00 ± 0.08	0.24 ± 0.05	4.95 ± 0.07	0.05 ± 0.05
Difference vs. placebo				0.12 ± 0.07		0.27 ± 0.07		0.08 ± 0.07
p value				0.091		<0.001		0.272
Difference vs. sitagliptin				0.04 ± 0.07		0.19 ± 0.07
p value				0.558		0.012
HDL cholesterol (mmol/l)	1.26 ± 0.02	0.03 ± 0.01	1.24 ± 0.02	0.11 ± 0.01	1.25 ± 0.02	0.12 ± 0.01	1.26 ± 0.02	0.02 ± 0.01
Difference vs. placebo				0.08 ± 0.02		0.09 ± 0.02		−0.01 ± 0.02
p value				<0.001		<0.001		0.647
Difference vs. sitagliptin				0.09 ± 0.02		0.09 ± 0.02
p value				<0.001		<0.001
LDL cholesterol (mmol/l)	2.90 ± 0.06	−0.04 ± 0.04	2.86 ± 0.07	0.03 ± 0.05	2.75 ± 0.07	0.15 ± 0.04	2.74 ± 0.05	0.07 ± 0.04
Difference vs. placebo				0.07 ± 0.06		0.19 ± 0.06		0.11 ± 0.06
p value				0.248		0.002		0.088
Difference vs. sitagliptin				−0.04 ± 0.06		0.09 ± 0.06
p value				0.581		0.174
LDL/HDL cholesterol ratio	2.43 ± 0.07	−0.11 ± 0.04	2.40 ± 0.06	−0.12 ± 0.04	2.32 ± 0.06	−0.05 ± 0.04	2.30 ± 0.05	0.00 ± 0.04
Difference vs. placebo				−0.01 ± 0.06		0.06 ± 0.06		0.12 ± 0.06
p value				0.921		0.256		0.040
Difference vs. sitagliptin				−0.12 ± 0.06		−0.05 ± 0.06
p value				0.033		0.358
Triglycerides (mmol/l)	2.01 ± 0.09	−0.03 ± 0.11	2.08 ± 0.12	−0.13 ± 0.11	2.37 ± 0.20	−0.02 ± 0.11	2.20 ± 0.13	−0.07 ± 0.11
Difference vs. placebo				−0.10 ± 0.16		0.01 ± 0.16		−0.04 ± 0.16
p value				0.532		0.931		0.795
Difference vs. sitagliptin				−0.06 ± 0.16		0.06 ± 0.16
p value				0.717		0.730

Baseline data are mean ± standard error, change from baseline data are adjusted mean ± standard error, based on ANCOVA in the full analysis set (last observation carried forward)
HDL high density lipoprotein, LDL low density lipoprotein

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