Table 1.
Efficay of oral dapagliflozin 10 mg once daily as add-on therapy in randomized, double-blind, multicentre, phase 3–4 trials and extensions in patients with T2D
| Study (mean diabetes duration) | Duration (weeks) | Treatment (no. of pts) | Adjusted meana change from BL [BL] | HbA1c < 7% (% of pts) | |||
|---|---|---|---|---|---|---|---|
| HbA1cb (%) | FPG (mmol/L) | BW (kg) | SBPc (mmHg) | ||||
| Matthaei et al. [57, 62] (≈ 9 years) | 24 | DAPA + MET + SU (108) | − 0.86*** [8.1] | − 1.9*** [9.3] | − 2.7*** [89] | − 4.0*c [135] | 32*** |
| PL + MET + SU (108) | − 0.17 [8.2] | − 0.04 [10.2] | − 0.6 [90] | − 0.3c [136] | 11 | ||
| 52 [57] | DAPA + MET + SU | − 0.8 | − 1.5 | − 2.9 | − 1.0 | 27 | |
| PL + MET + SU | − 0.2 | + 0.6 | − 1.0 | + 1.1 | 11 | ||
| Matheiu et al. [63] (≈ 8 years) | 24 | DAPA + SAX + MET (160) | − 0.82*** [8.2] | − 1.8*** [9.9] | − 1.9*** [86] | − 1.9* [NA] | 38*** |
| PL + SAX + MET (160) | − 0.10 [8.2] | − 0.3 [9.8] | − 0.4 [88] | + 2.0 [NA] | 12 | ||
| 52 [58] | DAPA + SAX + MET | − 0.74 | − 1.5 | − 2.1 | NA | 29 | |
| PL + SAX + MET | + 0.07 | + 0.6 | − 0.4 | NA | 13 | ||
| Müller-Wieland et al. [64] (≈ 7 years) | 52 | DAPA + SAX + MET (312) | − 1.2††d [8.3] | − 2.1†† [10.4] | − 3.2†† [95] | − 6.4†† [139] | 40 |
| DAPA + MET (311) | − 0.82d [8.3] | − 1.6 [10.6] | − 3.5†† [98] | − 5.6†† [138] | 20†† | ||
| GLIM + MET (309) | − 0.99d [8.3] | − 1.5 [10.4] | + 1.8 [98] | − 1.6 [139] | 34 | ||
| Handelsman et al. [65] (≈ 8 years) | 26 | DAPA + SAX + MET (232) | − 1.41†† [8.8] | − 1.8††† [9.5] | − 1.9††† | NA | 37† |
| SIT + MET (229) | − 1.07 [8.9] | − 0.6 [9.7] | − 0.5 | NA | 25 | ||
| 52 | DAPA + SAX + MET | − 1.29 | − 1.4 | − 2.3 | − 2.6 [130] | 33 | |
| SIT + MET | − 0.81 | − 0.2 | − 0.8 | + 2.5 [129] | 20 | ||
|
Frias et al. [61] (DURATION-8) (≈ 7 years) |
28 | DAPA + EXN + MET (228) | − 2.0§† [9.3] | − 3.66§†† [10.8] | − 3.6§†† [92] | − 4.3† [131] | 45§†† |
| DAPA + PL + MET (227) | − 1.4 [9.3] | − 2.73 [10.5] | − 2.2 [91] | − 1.8† [130] | 19 | ||
| PL + EXN + MET (230) | − 1.6 [9.3] | − 2.54 [10.5] | − 1.6 [89] | − 1.2 [129] | 27 | ||
| 104 [60]e | DAPA + EXN + MET | − 1.70§† | − 2.70§†† | − 2.5† | − 3.1† | NA | |
| DAPA + PL + MET | − 1.06 | − 1.20 | − 3.0 | − 1.1 | NA | ||
| PL + EXN + MET | − 1.29 | − 1.70 | − 0.8 | − 0.1 | NA | ||
| Vilsbøll et al. [66]e (NA) | 24 | DAPA + SAX + MET ± SU (324) | − 1.7d [9.0] | − 1.5†† | NA | 21†f | |
| INS + MET ± SU (319) | − 1.5d [9.0] | + 2.1 | NA | 13f | |||
| 52 [59]e | DAPA + SAX + MET ± SU | − 1.51† | − 1.83†† | NA | 15††f | ||
| INS + ME ± SU | − 1.26 | + 2.75 | NA | 7f | |||
No statistical comparisons available for two extension studies [57, 58] and nominal p values reported for two others [59, 60]
BL baseline, BW bodyweight, DAPA oral dapagliflozin 10 mg/day, EXN subcutaneous exenatide-extended release 2 mg once weekly, FPG fasting plasma glucose, GLIM oral glimepiride 4 mg/day, INS titrated insulin glargine (FPG goal ≤ 5.5 mmol/L), HbA1c glycated haemoglobin, MET oral metformin ≥ 1500 mg/day, NA not available, PL placebo, pts patients, SIT oral sitagliptin 100 mg/day, SAX oral saxagliptin 5 mg/day, SBP systolic blood pressure, SU oral sulfonylurea ≥ 50% of maximum dose
*p < 0.05, **p ≤ 0.001, ***p < 0.0001 vs. PL; †p < 0.05, ††p ≤ 0.001, †††p < 0.0001 vs. active comparator; §p < 0.001 vs. DAPA
aValues are least-squares mean in two studies [60, 61]
bPrimary endpoint for the main study
cSBP assessed at week 8 in one study [62]
dNoninferiority between treatment groups was demonstrated
eAbstract presentation
fProportion of patients achieving target HbA1c < 7% without hypoglycaemia