Table 5.
Patients with T2DM and HbA1c ≥7.0% at baseline who reached HbA1c <7.0% at end of treatment period: data from 24-week placebo-controlled empagliflozin trials
| Study | Study duration (wk) | EMPA regimen and background therapy | N | Treatment and dose (mg/d) | Mean baseline HbA1c (%) | Patients with HbA1c <7.0%, n (%)a |
|---|---|---|---|---|---|---|
| Roden et al15 | 24 | Monotherapy in treatment naïve patients | 228 | Pbo | 7.91 | 25/208 (12) |
| 224 | EMPA 10 | 7.87 | 72/204 (35) | |||
| 224 | EMPA 25 | 7.86 | 88/202 (44) | |||
| 223 | SITA 100 | 7.85 | 75/200 (38) | |||
| 87 | O/L EMPA 25 (HbA1c >10.0%) | 11.50 | 24/87 (28) | |||
| Häring et al19 | 24 | Add-on to stable metformin (≥1,500 mg/d or MTD or MDLL) | 207 | Pbo | 7.90 | 23 (12.5) |
| 217 | EMPA 10 | 7.94 | 75 (37.7) | |||
| 213 | EMPA 25 | 7.86 | 74 (38.7) | |||
| 69 | O/L EMPA 25 (HbA1c >10.0%) | 11.07 | 6 (8.7) | |||
| Kovacs et al21 | 24 | Add-on to stable pioglitazone (≥30 mg/d) ± metformin (≥1,500 mg/d or MTD) | 165 | Pbo | 8.2 | 12 (7.7) |
| 165 | EMPA 10 | 8.1 | 36 (23.8) | |||
| 168 | EMPA 25 | 8.1 | 48 (30.0) | |||
| Häring et al22 | 24 | Add-on to stable metformin (≥1,500 mg/d or MTD) plus sulfonylurea (≥half-max labeled dose or MTD) | 225 | Pbo | 8.15 | 20 (9.3) |
| 225 | EMPA 10 | 8.07 | 55 (26.3) | |||
| 216 | EMPA 25 | 8.10 | 65 (32.2) | |||
| 101 | O/L EMPA 25 (HbA1c >10.0%) | 11.18 | 9 (8.9) |
Note:
a
Patients with HbA1c ≥7.0% at baseline who reached HbA1c <7.0% at end of treatment period.
Abbreviations: EMPA, empagliflozin; HbA1c, glycated hemoglobin; MDLL, maximum dose per local label; MTD, maximum tolerated dose; O/L, open label; Pbo, placebo; SITA, sitagliptin; T2DM, type 2 diabetes mellitus.