Table 1.
Baseline patient characteristics in multiple dose trial
| Saxagliptin group
|
Placebo group (n=87) | |||
|---|---|---|---|---|
| 1 mg (n=93) | 2.5 mg (n=88) | 5 mg (n=82) | ||
| Age (year) | 57.0±10.9 | 56.3±9.7 | 57.7±10.2 | 58.7±9.0 |
| Male, n (%) | 61 (65.6) | 59 (67.0) | 55 (67.1) | 57 (65.5) |
| BMI (kg/m2) | 24.70±4.25 | 25.51±4.19 | 24.82±3.92 | 24.68±5.06 |
| Duration of T2DM (year) | 5.55±5.27 | 4.98±4.34 | 5.25±5.09 | 4.96±4.14 |
| HbA1c (NGSP) (%) | 8.69±0.76 | 8.40±0.76 | 8.47±0.77 | 8.05±0.71 |
| Fasting plasma glucose (mg/dL) | 173.6±35.7 | 166.8±32.5 | 162.4±29.8 | 168.2±35.9 |
| Fasting glycoalbumin (%) | 24.59±4.32 | 23.54±3.66 | 23.20±3.10 | 24.37±4.24 |
| Fasting IRI (μU/mL) | 6.91±4.80 | 7.01±4.28 | 6.98±6.24 | 6.78±4.79 |
| Fasting CPR (ng/mL) | 2.33±0.89 | 2.41±0.88 | 2.36±0.92 | 2.33±0.87 |
| HOMA-β (%) | 24.32±17.20 | 26.25±17.93 | 27.40±30.44 | 25.51±19.86 |
| HOMA-R | 2.99±2.30 | 2.91±1.87 | 2.80±2.31 | 2.80±2.03 |
Notes: Values are mean ± SD. Because prior to the start of the test, HbA1c data was not obtained after administration, one case of 5 mg group was excluded from the analysis of target efficacy.
Abbreviations: BMI, body mass index; T2DM, type 2 diabetes mellitus; IRI, immunoreactive insulin; CPR, plasma C-peptide; HbA1c, glycated hemoglobin; HOMA-IR, homeostatic model insulin resistance; HOMA-β, homeostatic model assessment of β-cells; SD, standard deviation; NGSP, National Glycohemoglobin Standardization Program.