. Author manuscript; available in PMC: 2018 Feb 1.

Published in final edited form as: Lancet Diabetes Endocrinol. 2017 Jun 11;5(8):597–609. doi: 10.1016/S2213-8587(17)30194-8

Table 3.

Secondary outcomes

	Baseline		36 months		Change (ANCOVA)^*or OR^†(95% CI)	Main effect p value	Interaction p value^‡
	Metformin	Placebo	Metformin	Placebo
HbA_1c (%)	8·1 (0·9)	8·0 (0·8)	8·1 (0·9)	8·1 (0·8)	−0·13 (−0·22 to −0·04)^*	0·0060	0·0163
LDL cholesterol (mmol/L)	2·23 (0·70)	2·25 (0·72)	2·07 (0·83)	2·21 (0·71)	−0·13 (−0·24 to −0·03)^*	0·0117	0·3101
eGFR (mL/min/1·73m²)	92·9 (20·9)	91·1 (21·6)	92·1 (20·8)	87·2 (19·6)	4·00 (2·19 to 5·81)^*	<0·0001	0·6624
Retinopathy (%; ≥ two-step progression)	..^§	..^§	8 (6)	10 (8)	0·76 (0·29 to 1·98)^†	0·5683	..^¶
Bodyweight (kg)	83·9 (15·4)	83·5 (13·7)	82·0 (15·4)	83·2 (13·8)	−1·17 (−1·66 to −0·69)^*	<0·0001	0·2736
Insulin dose (units per kg)	0·63 (0·26)	0·68 (0·30)	0·62 (0·26)	0·67 (0·30)	−0·005 (−0·022 to 0·012)^*	0·5450	0·0018
Endothelial function (RHI; arbitrary units)	2·28 (0·74)	2·24 (0·75)	2·17 (0·69)	2·24 (0·73)	−0·06 (−0·19 to 0·06)^*	0·3016	0·5662

Data are mean (SD) for continuous data or n (%) for categorical data. Treatment effect and corresponding 95% CIs are provided for metformin compared with placebo. eGFR=estimated glomerular filtration rate. RHI=reactive hyperaemia index.

ANCOVA for the change from baseline, adjusted for the baseline value, for continuous data.

^†

Odds ratio (OR) and 95% CI for binary data obtained by logistic regression models.

^‡

Visit-by-treatment interaction.

^§

Refer to table 1 for baseline retinopathy data.

^¶

No visit-by-treatment interaction term is available for retinopathy as it was assessed at only two visits (randomisation and close-out).