Table 3B.
Glycemic efficacy at 24 weeks in older and younger patients with type 2 diabetes mellitus from a study of saxagliptin 5 mg as initial combination therapy with metformin vs metformin monotherapy22
| Age ≥ 65 years
|
Age < 65 years
|
|||
|---|---|---|---|---|
| SAXA 5 mg + MET | MET | SAXA 5 mg + MET | MET | |
| Primary endpoint | ||||
| Change in HbA1c (%) | n = 33 | n = 36 | n = 273 | n = 277 |
| Mean HbA1c at baseline | 9.18 | 8.87 | 9.44 | 9.51 |
| Mean HbA1c at week 24 | 7.00 | 7.43 | 6.93 | 7.49 |
| Δ | −2.48 | −1.26 | −2.55 | −2.01 |
| 95% 2-sided CI for Δ | (−3.35, −1.60) | (−1.83, −0.68) | (−2.69, −2.40) | (−2.16, −1.87) |
| Difference in Δ vs MET monotherapya | −1.22 | −0.53 | ||
| 95% 2-sided CI for difference in Δ vs MET monotherapy | (−2.27, −0.17) | (−0.74, −0.33) | ||
| Secondary endpoints | ||||
| FPG (mg/dL) | n = 33 | n = 36 | n = 282 | n = 284 |
| Δ | −65.7 | −44.9 | −58.0 | −46.5 |
| Difference in Δ vs MET monotherapya | −20.7 | −11.5 | ||
| 95% 2-sided CI for difference in Δ vs MET monotherapy | (−39.7, −1.8) | (−18.1, −4.9) | ||
| PPG-AUC0–180 (mg ⋅ min/dL) | n = 10 | n = 9 | n = 132 | n = 126 |
| Δ | −22504 | −6841 | −20736 | −15393 |
| Difference in Δ vs MET monotherapya | −15663 | −5343 | ||
| 95% 2-sided CI for difference in Δ vs MET monotherapy | (−24413, −6913) | (−7720, −2965) | ||
| PPG-120 (mg/dL) | n = 10 | n = 9 | n = 136 | n = 132 |
| Δ | −136.8 | −34.63 | −136.2 | −99.67 |
| Difference in Δ vs MET monotherapya | −102.2 | −36.5 | ||
| 95% 2-sided CI for difference in Δ vs MET monotherapy | (−161.7, −42.7) | (−52.4, −20.7) | ||
| Glycemic response | n = 33 | n = 36 | n = 274 | n = 278 |
| % achieving HbA1c < 7.0% | 57.6% | 38.9% | 60.6% | 41.4% |
| Difference vs MET monotherapy | 18.7% | 19.2% | ||
| 95% 2-sided CI for difference vs | (−5.7, 40.6) | (10.9, 27.3) | ||
| MET monotherapy | ||||
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.