Table 3A.
Glycemic efficacy at 24 weeks in older and younger patients with type 2 diabetes mellitus from five pooled studies of saxagliptin vs placebo as monotherapy and as add-on therapy18–21,24
| Age ≥ 65 years
|
Age < 65 years
|
|||||
|---|---|---|---|---|---|---|
| SAXA 2.5 mg | SAXA 5 mg | PBO | SAXA 2.5 mg | SAXA 5 mg | PBO | |
| Primary endpoint | ||||||
| Change in HbA1c (%) | n = 135 | n = 138 | n = 136 | n = 656 | n = 723 | n = 643 |
| Mean HbA1c at baseline | 8.13 | 8.06 | 7.91 | 8.19 | 8.24 | 8.23 |
| Mean HbA1c at week 24 | 7.44 | 7.29 | 7.91 | 7.63 | 7.55 | 8.22 |
| Δ | −0.78 | −0.73 | −0.17 | −0.57 | −0.68 | −0.01 |
| 95% 2-sided CI for Δ | (−1.05, −0.50) | (−1.04, −0.42) | (−0.45, 0.10) | (−0.65, −0.50) | (−0.75, −0.61) | (−0.09, 0.07) |
| Difference in Δ vs PBOa | −0.60 | −0.55 | −0.56 | −0.67 | ||
| 95% 2-sided CI for difference in Δ vs PBO | (−0.99, −0.21) | (−0.97, −0.14) | (−0.67, −0.46) | (−0.77, −0.56) | ||
| Secondary endpoints | ||||||
| FPG (mg/dL) | n = 137 | n = 140 | n = 135 | n = 662 | n = 731 | n = 650 |
| Δ | −11.7 | −15.7 | −4.1 | −10.6 | −13.3 | 2.4 |
| Difference in Δ vs PBOa | −7.6 | −11.6 | −13.1 | −15.7 | ||
| 95% 2-sided CI for difference in Δ vs PBO | (−17.4, 2.2) | (−21.4, −1.9) | (−17.5, −8.6) | (−20.1, −11.3) | ||
| PPG-AUC0–180 (mg ⋅ min/dL) | n = 109 | n = 100 | n = 93 | n = 504 | n = 542 | n = 478 |
| Δ | −8332 | −8493 | −3522 | −6659 | −7760 | −1387 |
| Difference in Δ vs PBOa | −4810 | −4970 | −5272 | −6373 | ||
| 95% 2-sided CI for difference in Δ vs PBO | (−7697, −1923) | (−7916, −2024) | (−6577, −3967) | (−7659, −5088) | ||
| PPG-120 (mg/dL) | n = 112 | n = 105 | n = 97 | n = 520 | n = 561 | n = 489 |
| Δ | −56.0 | −54.0 | −20.98 | −45.6 | −50.7 | −7.7 |
| Difference in Δ vs PBOa | −35.0 | −33.0 | −37.9 | −43.1 | ||
| 95% 2-sided CI for difference in Δ vs PBO | (−55.3, −14.8) | (−53.5, −12.4) | (−47.1, −28.7) | (−52.1, −34.0) | ||
| Glycemic response | n = 135 | n = 138 | n = 136 | n = 656 | n = 724 | n = 643 |
| % achieving HbA1c < 7.0% | 37.8% | 44.9% | 16.9% | 32.5% | 34.5% | 19.0% |
| Difference vs PBOa | 21.4% | 25.9% | 13.3% | 14.7% | ||
| 95% 2-sided CI for difference vs PBO | (9.8, 32.9) | (14.5, 37.3) | (8.6, 18.0) | (9.8, 19.6) | ||
Note:
a
Baseline-adjusted mean change with saxagliptin – baseline-adjusted mean change with control.
Abbreviations: Δ, baseline-adjusted mean change from baseline to week 24; CI, confidence interval; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; PBO, placebo; PPG, postprandial glucose; PPG-120, PPG change from baseline at 120 minutes in oral glucose tolerance test (OGTT); PPG-AUC0–180, postprandial glucose-area under the curve for the period 0–180 minutes on OGTT; SAXA, saxagliptin.