Table 2. Changes in glycemic/metabolic parameters from baseline to the completion of the 12‐week treatment period in glimepiride monotherapy, alogliptin 12.5 mg and alogliptin 25 mg groups.
| Placebo + glimepiride (n = 103) | Alogliptin 12.5 mg + glimepiride (n = 105) | Alogliptin 25 mg + glimepiride (n = 104) | |
|---|---|---|---|
| ∆HbA1c (%) | 0.35 (0.059) | −0.59 (0.058)*** | −0.65 (0.059)*** |
| Responders (%): HbA1c <6.9% | 0 (0.0) | 10 (9.6)* | 8 (7.7)* |
| Responders (%): HbA1c <7.4% | 4 (3.9) | 31 (29.8)* | 36 (34.6)* |
| ∆ Fasting plasma glucose (mg/dL) | 6.0 (32.97) | −22.3 (31.05)* | −15.9 (28.12)* |
| ∆ Fasting C peptide (ng/mL) | −0.00 (0.597) | 0.06 (0.402) | 0.02 (0.375) |
| ∆ Fasting insulin (μU/mL) | −0.12 (3.315) | 0.57 (2.580) | 0.53 (2.292) |
| ∆ Fasting glucagon (pg/mL) | −12.4 (33.21) | −12.0 (24.59) | −10.4 (22.32) |
| ∆ Glycoalbumin (%) | 0.99 (2.353) | −2.60 (2.467)* | −3.05 (2.504)* |
| ∆ 1,5‐AG (μg/mL) | −0.33 (1.418) | 2.43 (2.269)* | 2.77 (2.976)* |
| ∆ Fasting proinsulin (pmol/L) | −1.82 (5.864) | −3.19 (6.074) | −2.82 (4.415) |
| ∆ Insulinogenic index | −0.07 (0.720) | 0.11 (0.504) | 0.05 (0.363) |
| ∆ Proinsulin/insulin ratio | −0.403 (0.9485) | −0.582 (0.7921) | −0.701 (0.7084)* |
| Inhibition rate of DPP‐4 activity (%) at week 4 | 1.25 (7.930) | 74.88 (5.817)* | 81.22 (8.593)* |
| Inhibition rate of DPP‐4 activity (%) at week 8 | 2.37 (7.293) | 75.45 (6.965)* | 81.47 (11.134)* |
| Inhibition rate of DPP‐4 activity (%) at week 12 | 0.23 (9.661) | 75.09 (7.223)* | 81.15 (11.974)* |
| ∆ HOMA‐R | 0.02 (2.064) | −0.17 (1.255) | −0.01 (1.345) |
| ∆ HOMA‐β | −0.94 (9.813) | 10.73 (20.162)* | 5.70 (10.252)* |
| ∆ Bodyweight (kg) | −0.37 (1.213) | 0.27 (1.225)* | 0.56 (1.105)* |
| ∆ Abdominal circumference (cm) | −1.00 (2.749) | 0.01 (3.303)* | 0.24 (3.736)* |
| Meal tolerance test | |||
| ∆ Plasma glucose 2‐h (mg/dL) | 8.1 (42.69) | −44.4 (52.18)* | −33.3 (47.78)* |
| ∆ Plasma glucose AUC0–2 h (mg·h/dL) | 13.7 (66.33) | −77.6 (78.36)* | −61.0 (69.73)* |
| ∆ Insulin AUC0–2 h (μU.hr/mL) | 0.79 (17.366) | 3.63 (21.726) | 4.53 (12.085) |
| ∆ C‐peptide AUC0–2 h (ng.hr/mL) | −0.08 (1.300) | 0.17 (1.442) | 0.29 (1.309) |
| ∆ Glucagon AUC0–2 h (pg.hr/mL) | −24.0 (60.73) | −28.3 (43.27)* | −25.2 (41.26)* |
| ∆ Active GLP‐1 concentrations (pg.hr/mL) | 0.17 (3.61) | 12.71 (21.98)* | 11.56 (11.20)* |
| Serum lipids | |||
| ∆ Total cholesterol (mg/dL) | −0.1 (26.83) | −2.6 (24.31) | −1.7 (24.80) |
| ∆ LDL‐cholesterol (mg/dL) | −1.6 (22.59) | −3.1 (19.65) | −1.8 (20.13) |
| ∆ HDL‐cholesterol (mg/dL) | −1.6 (7.68) | −1.4 (8.64) | −2.7 (7.18) |
| ∆ Triglycerides (mg/dL) | 13.0 (214.59) | −10.0 (67.14) | 0.2 (48.43) |
| ∆ Free fatty acids (mEg/L) | 0.057 (0.2151) | −0.070 (0.2031) | −0.059 (0.2020) |
1,5‐AG, 1,5‐anhydroglucitol; AUC0–2 h, area under the blood glucagon concentration time curve from 0 to 2 hours; DDP‐4, dipeptidyl peptidase IV; FPG, fasting plasma glucose; GLP‐1, glucagon‐like peptide‐1; HbA1c, glycated hemoglobin; HDL, high‐density lipoprotein; HOMA‐R, homeostasis model assessment of insulin resistance; HOMA‐β, homeostasis model assessment of β‐cell function; LDL, low‐density lipoprotein. Values shown are mean (SD) or (95% CI); ∆, change from baseline. *P < 0.05 vs placebo. ***P < 0.0001 vs placebo.