Table 2.

Secondary outcomes.

A. HbA1c [%] change from baseline at Week 26 – mITT set
Treatment	N analysed	Baseline		Change from baseline			Comparison versus placebo
		Mean	SD	Adjusted mean	95% CI		Adjusted mean	95% CI
Primary hypotheses (empagliflozin pooled vs. placebo and linagliptin vs. placebo)
Placebo	53	8·05	1·23	0·68	0·23	1·13
Empagliflozin pooled	52	8·00	1·29	−0·17	−0·64	0·31	−0·84	−1·50	−0·19*
Linagliptin 5 mg	52	8·05	1·11	0·33	−0·13	0·79	−0·34	−0·99	0·30†
Secondary hypothesis (empagliflozin responders on 10 mg plus empagliflozin non-responders titrated to 25 mg vs. placebo)
Placebo	53	8·05	1·23	0·66	0·12	1·21
Empagliflozin 10 mg +titr 25 mg	41	7·80	1·26	0·14	−0·42	0·71	−0·52	−1·31	0·27‡
Secondary hypothesis (empagliflozin responders on 10 mg plus empagliflozin non-responders on 10 mg vs. placebo)
Placebo	53	8·05	1·23	0·68	0·19	1·17
Empagliflozin 10 mg +titr 10 mg	39	7·92	1·36	−0·49	−1·03	0·04	−1·18	−1·90	−0·45§
B. Secondary endpoints based on FPG, body weight, SBP and DBP: change from baseline at Week 26 – mITT set
Treatment	N analysed	Baseline		Change from baseline			Comparison versus placebo
		Mean	SD	Adjusted mean	95% CI		Adjusted mean	95% CI
Fasting plasma glucose (mg/dL)
Placebo	52	158·62	53·80	15·70	−0·53	31·93
Empagliflozin pooled	48	154·43	57·78	−19·48	−36·39	−2·57	−35·18	−58·61	−11·74
Linagliptin 5 mg	51	162·81	56·01	10·29	−6·12	26·69	−5·41	−28·49	17·67
Body weight (kg)
Placebo	52	98·87	29·62	−0·04	−1·40	1·32
Empagliflozin pooled	52	98·66	24·35	−0·79	−2·17	0·59	−0·75	−2·68	1·19
Linagliptin 5 mg	50	102·73	26·81	1·42	0·04	2·81	1·46	−0·48	3·41
Systolic blood pressure (mmHg)
Placebo	52	118·34	11·87	1·30	−1·01	3·61
Empagliflozin pooled	52	120·23	9·97	−0·12	−2·47	2·24	−1·42	−4·72	1·88
Linagliptin 5 mg	50	122·39	11·13	2·21	−0·14	4·56	0·91	−2·40	4·22
Diastolic blood pressure (mmHg)
Placebo	52	72·60	8·94	0·76	−1·01	2·53
Empagliflozin pooled	52	72·03	8·38	0·78	−1·04	2·60	0·02	−2·52	2·56
Linagliptin 5 mg	50	74·01	8·13	2·26	0·46	4·05	1·50	−1·03	4·02

Analyses including all available HbA1c data on treatment, after start of rescue medication and after premature treatment discontinuation

Missing data multiply imputed with ‘wash-out’ approach, using ANCOVA with baseline HbA1c as linear, treatment and age as categorical covariates and applying Rubin’s rules to combine multiple imputations

Mean change from baseline was adjusted for baseline HbA1c and age category for all hypotheses and additionally weighted for secondary hypotheses

Baseline means were not weighted

^*p-value=0·012,

^†p-value=0·29,

^‡p-value=0·19,

^§p-value=0·0015.

To convert the values for % HbA1c to millimoles per mol, subtract 2·15 and multiply the result by 10·929. HbA1c, glycated haemoglobin; mITT, modified intention-to-treat; SD, standard deviation; titr, empagliflozin non-responders titrated to.

Analyses including all available data on treatment, after start of rescue medication and after premature treatment discontinuation

Mean change from baseline was adjusted for baseline value and age category

FPG analysed by ANCOVA with baseline value as linear, treatment and age as categorical covariates, baseline carried forward for missing FPG at week 26

All other endpoints analysed by MMRM including additionally visit as fixed, categorical covariate, interactions of treatment and baseline with visit and patient as random effect with unstructured covariance structure

DBP, diastolic blood pressure; FPG, fasting plasma glucose, mITT, modified intention-to-treat; SBP, systolic blood pressure; SD, standard deviation.