Table 3.

Adjusted mean change from baseline in fasting biomarkers and derived indices at week 24 (full analysis set, last observation carried forward)

	Linagliptin	Placebo
HOMA-%B [(mU/l)/(mmol/l)]
Patients with baseline and on-treatment results, n	138	69
Baseline, gMean (gCV)	43.75 (110.63)	44.58 (87.67)
Relative change from baseline
Adjusted* gMean ratio, % 95% CI	1.41 1.14–1.74	1.11 0.88–1.39
Comparison vs. placebo
Adjusted* gMean ratio, %	1.27
95% CI	1.07–1.50
P-value	0.0055
HOMA-IR [(mU/l) × (mmol/l)]
Patients with baseline and on-treatment results, n	139	69
Baseline, gMean (gCV)	2.91 (83.50)	2.97 (75.01)
Relative change from baseline
Adjusted† gMean ratio, % 95% CI	1.05 0.95–1.16	1.10 0.95–1.27
Comparison vs. placebo
Adjusted† gMean ratio, %	0.96
95% CI	0.80–1.14
P-value	0.6023
Disposition index [1/((mmol/l) × (mmol/l))]
Patients, n	148	71
Baseline, mean (se)	24.67 (4.53)	22.56 (3.75)
Change from baseline
Adjusted‡ mean (se)	14.53 (18.39)	10.13 (18.50)
Comparison vs. placebo
Adjusted‡ mean (se)	4.41 (3.62)
95% CI	–2.74 to 11.55
P-value	0.2255

^*Adjusted model includes treatment, continuous baseline HbA_1c, continuous HOMA-%B at baseline and centre as random.

^†Adjusted model includes treatment, continuous baseline HbA_1c, continuous HOMA-IR at baseline and centre as random.

^‡Adjusted model includes treatment, continuous baseline HbA_1c, continuous disposition index at baseline and centre as random.

gMean, geometric mean

HOMA-%B, homeostasis model assessment of β-cell function; HOMA-IR, homeostasis model assessment of insulin resistance.