Table 2. Primary and secondary outcomes, according to treatment group at 26 weeks.
| Variable | Pioglitazone | Glimepiride | Inter-group difference, P value |
|---|---|---|---|
| Primary outcome | |||
| HbA1c (%) in ITT population | |||
| Number | 69 | 66 | |
| Baseline | 8.25±0.58 | 8.16±0.61 | 0.386 |
| Week 26 | 7.44±1.13 | 7.11±0.76 | |
| Change from baseline | −0.81±1.10 | −1.05±0.87 | 0.165 |
| P value | <0.001 | <0.001 | |
| HbA1c (%) in PP population | |||
| Number | 58 | 58 | |
| Baseline | 8.21±0.56 | 8.20±0.63 | 0.938 |
| Week 26 | 7.16±0.82 | 7.07±0.76 | |
| Change from baseline | −1.04±0.94 | −1.12±0.87 | 0.630 |
| P value | <0.001 | <0.001 | |
| Secondary outcomes in PP population | |||
| Total cholesterol, mg/dL | |||
| Baseline | 153.34±32.51 | 151.40±33.66 | |
| Week 26 | 160.31±35.65 | 152.33±34.45 | |
| Change from baseline | 6.97±27.08 | 0.92±19.91 | 0.174 |
| P value | 0.055 | 0.725 | |
| Triglyceride, mg/dL | |||
| Baseline | 132.84±72.15 | 146.17±71.58 | |
| Week 26 | 113.02±51.47 | 130.72±67.03 | |
| Change from baseline | −19.83±69.69 | −15.45±56.76 | 0.711 |
| P value | 0.034 | 0.043 | |
| LDL-C, mg/dL | |||
| Baseline | 88.26±32.51 | 87.62±27.62 | |
| Week 26 | 90.14±34.56 | 88.01±29.93 | |
| Change from baseline | 1.88±27.02 | 0.39±17.99 | 0.727 |
| P value | 0.598 | 0.870 | |
| HDL-C, mg/dL | |||
| Baseline | 49.19±14.20 | 47.22±9.91 | |
| Week 26 | 54.76±18.18 | 48.16±11.29 | |
| Change from baseline | 5.57±9.58 | 0.94±8.47 | 0.007 |
| P value | <0.001 | 0.403 | |
| HOMA-IR | |||
| Baseline | 4.10±3.03 | 3.98±3.01 | |
| Week 26 | 2.58±1.56 | 3.43±2.69 | |
| Change from baseline | −1.53±2.74 | −0.54±2.72 | 0.054 |
| P value | <0.001 | 0.133 | |
| HOMA-β | |||
| Baseline | 32.57±23.24 | 40.59±59.45 | |
| Week 26 | 38.72±25.18 | 45.81±26.71 | |
| Change from baseline | 6.15±24.15 | 5.21±59.75 | 0.912 |
| P value | 0.057 | 0.509 |
Values are presented as mean±standard deviation. P<0.05 was considered significant.
HbA1c, glycosylated hemoglobin; ITT, intention-to-treat; PP, per-protocol; LDL-C, low density lipoprotein cholesterol; HDL-C, high density lipoprotein cholesterol; HOMA-IR, homeostasis model assessment as an index of insulin resistance; HOMA-β, homeostatic model assessment β-cell function.