Table 3.
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 HbA1c, continuous HOMA-%B at baseline and centre as random.
Adjusted model includes treatment, continuous baseline HbA1c, continuous HOMA-IR at baseline and centre as random.
Adjusted model includes treatment, continuous baseline HbA1c, 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.