Table 3.
Summary of effectiveness endpoints at 3, 6, and 12 months.
| Parameters | Time period |
|||
|---|---|---|---|---|
| Baseline | 3 months | 6 months | 12 months | |
| HbA1c (%) | ||||
| Overall efficacy population | 9.6 ± 1.92 | 8.3 ± 1.61 | 8.1 ± 1.39 | 7.8 ± 1.18 |
| Change from BL in overall efficacy population | −0.8 ± 1.23 | −1.4 ± 1.50 | −1.8 ± 1.68 | |
| Previous medication OAD subgroup | 9.5 ± 1.83 | 8.2 ± 1.52 | 7.9 ± 1.26 | 7.5 ± 0.99 |
| Change from BL in OAD subgroup | −0.9 ± 1.16 | −1.4 ± 1.43 | −1.9 ± 1.59 | |
| Previous medication insulin subgroup | 9.8 ± 2.08 | 8.8 ± 1.73 | 8.5 ± 1.60 | 8.2 ± 1.39 |
| Change from BL in insulin subgroup | −0.5 ± 1.32 | −1.3 ± 1.66 | −1.6 ± 1.87 | |
| FPG (mg/dL) | ||||
| Overall efficacy population | 190.7 ± 69.02 | 145.0 ± 49.77 | 132.5 ± 37.58 | 125.4 ± 31.86 |
| Change from BL in overall efficacy population | −45.1 ± 62.97 | −57.2 ± 69.84 | −64.7 ± 72.84 | |
| Previous medication OAD subgroup | 185.3 ± 62.21 | 143.0 ± 45.64 | 131.7 ± 36.17 | 123.0 ± 27.16 |
| Change from BL in OAD subgroup | −43.3 ± 51.85 | −52.2 ± 59.83 | −62.3 ± 63.96 | |
| Previous medication insulin subgroup | 202.9 ± 81.17 | 149.8 ± 58.36 | 134.4 ± 40.63 | 130.2 ± 39.26 |
| Change from BL in insulin subgroup | −49.6 ± 85.09 | −69.6 ± 89.27 | −70.4 ± 90.41 | |
| PPG, post-breakfast (mg/dL) | ||||
| Overall efficacy population | 277.4 ± 81.69 | 212.0 ± 60.14 | 199.8 ± 52.33 | 187.1 ± 48.33 |
| Change from BL in overall efficacy population | −60.3 ± 79.30 | −72.1 ± 87.10 | −86.1 ± 94.80 | |
| Previous medication OAD subgroup | 276.5 ± 75.70 | 212.0 ± 58.91 | 198.1 ± 49.63 | 181.2 ± 39.66 |
| Change from BL in OAD subgroup | −62.7 ± 70.76 | −77.9 ± 82.76 | −94.1 ± 83.65 | |
| Previous medication insulin subgroup | 279.1 ± 93.23 | 211.9 ± 62.73 | 202.9 ± 56.84 | 196.8 ± 58.78 |
| Change from BL in insulin subgroup | −55.0 ± 95.57 | −60.6 ± 94.43 | −70.2 ± 112.4 | |
| PPG, post-lunch (mg/dL) | ||||
| Overall efficacy population | 273.3 ± 109.40 | 201.6 ± 58.33 | 191.2 ± 49.19 | 174.3 ± 34.63 |
| Change from BL in overall efficacy population | −55.0 ± 74.46 | −69.3 ± 86.70 | −87.8 ± 100.2 | |
| Previous medication OAD subgroup | 267.8 ± 95.70 | 192.9 ± 51.33 | 186.1 ± 41.42 | 171.6 ± 33.91 |
| Change from BL in OAD subgroup | −58.5 ± 72.90 | −70.4 ± 84.62 | −85.7 ± 97.62 | |
| Previous medication insulin subgroup | 286.0 ± 135.6 | 220.3 ± 67.78 | 203.7 ± 63.15 | 179.2 ± 35.59 |
| Change from BL in insulin subgroup | −45.9 ± 78.32 | −66.5 ± 93.15 | −94.8 ± 109.1 | |
| Confirmed hypoglycemic eventsa | ||||
| Overall (N = 1024) | 50 (122) | 13 (24) | 18 (23) | 27 (37) |
| Patients receiving previous insulin (N = 681) | – | 7 (9) | 6 (9) | 11 (17) |
| Patients receiving previous OAD (N = 343) | – | 6 (15) | 12 (14) | 16 (20) |
Abbreviations: BL, baseline; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; N: number of patients; OAD, oral antidiabetic drugs; PPG, postprandial plasma glucose.
Change from baseline significant at all-time points for all values (p < 0.0001).
Values expressed at mean ± standard deviation.
Values calculated at last observation carried forward for missing patients.
a
Confirmed hypoglycemic events presented as number of patients (number of events).