Table 2.
Efficacy data summary from the main phase 3 clinical trials of dapagliflozin, canagliflozin and empagliflozin*
| Study details (N §) | Treatment, dose (mg/day) | Change from baseline† , ‡ | |||
|---|---|---|---|---|---|
| HbA1c (%) | FPG (mg/dl) | Body weight (kg) | SBP (mmHg) | ||
| Dapagliflozin | |||||
| Monotherapy, 24 weeks (N = 485) 51 | Pbo | −0.23 | −4.1 | −2.2 | −0.9 |
| Dapa 5/10 | −0.77 to −0.89 | −24.1 to −29.6 | −2.8 to −3.6 | −2.3 to −5.2 | |
| Monotherapy (A1c ≥10.1), 24 weeks (N = 73) 51 | Dapa 5/10 | −2.88/−2.66 | −77.1/−84.3 | −2.1/−1.9 | −5.7/−2.5 |
| Add‐on to MET, 24 weeks (N = 546) 52 | Pbo | −0.30 | −5.95 | −0.9 | −0.2 |
| Dapa 5/10 | −0.70/−0.84 | −21.44/−23.42 | −3.0/−2.9 | −4.3/−5.1 | |
| Initial combination with MET XR, 24 weeks (N = 1244) 53 | Pbo + MET XR | −1.35 to −1.44 | −33.51 to −34.78 | −1.29 to −1.36 | −1.2 to −1.8 |
| Dapa 5/10 + MET XR | −1.98 to −2.05 | −60.36 to −61.09 | −2.66 to −3.33 | −2.9 to −3.30 | |
| Add‐on to SU (GLIM), 24 weeks (N = 597) 54 | Pbo | −0.13 | −1.98 | −0.72 | −1.2 |
| Dapa 5/10 | −0.63 to −0.82 | −21.26 to −28.47 | −1.56 to −2.26 | −4.0 to −5.0 | |
| Add‐on to DPP4i (SITA) ± MET, 24 weeks (N = 432) 55 | Pbo + SITA | 0.1 | 4.6 | −0.1 | −4.2 |
| Dapa 10 + SITA | −0.5 | −22.0 | −1.9 | −6.6 | |
| Pbo + SITA + MET | −0.0 | 3.0 | −0.5 | −5.5 | |
| Dapa 10 + SITA + MET | −0.4 | −26.2 | −2.4 | −5.3 | |
| Add‐on to MET, 52 weeks (N = 814) 56 | Dapa 2.5–10 | −0.52 | −22.34 | −3.22 | −4.3 |
| GLIP 5–20 | −0.52 | −18.74 | 1.44 | 0.8 | |
| Add‐on to TZD, 48 weeks (N = 420) 57 | Pbo | −0.54 | −13.1 | 2.99 | 2.0 |
| Dapa 5/10 | −0.95 to −1.21 | −22.8 to −33.1 | 0.69 to 1.35 | −1.0 to −2.2 | |
| Add‐on to INS (≥ 30 units/day) ± OAD, 48 weeks (N = 800) 58 | Pbo | −0.47 | N/r | 0.82 | −1.49 |
| Dapa 5/10 | −0.96 to −1.01 | N/r | −1.00 to −1.61 | −4.09 to −4.33 | |
| Canagliflozin | |||||
| Monotherapy, 26 weeks (N = 584) 59 | Pbo | 0.14 | 9.00 | −0.5 | 0.4 |
| Cana 100/300 | −0.77 to −1.03 | −27.03 to −34.23 | −2.5 to −3.4 | −3.3 to −5.0 | |
| Monotherapy (A1c>10.0 ≤ 12.0) (N = 94) 59 | Cana 100/300 | −2.1 to −2.6 | −81.1 to −86.5 | −3.0 to −3.8 | −4.5 to −5.0 |
| Add‐on to MET, 52 weeks (N = 1450) 60 | GLIM 1–8 | −0.81 | −18.0 | 0.7 | 0.2 |
| Cana 100/300 | −0.82 to −0.93 | −25.2 to −27.0 | −3.7 to −4.0 | −3.3 to −4.6 | |
|
Add‐on to MET, 52 weeks (N = 1284) 61
(26 weeks Pbo + comparator; 26 weeks comparator) |
SITA 100 | −0.73 | −17.7 | −1.3% | −0.7 |
| Cana 100/300 | −0.73 to −0.88 | −26.2 to −35.2 | −3.8 to −4.2% | −3.5 to −4.7 | |
| Add‐on to MET + SU, 52 weeks (N = 755) 62 | SITA 100 | −0.66 | −2.2 | 0.1 | 0.9 |
| Dapa 300 | −1.03 | −28.7 | −2.3 | −5.1 | |
| Add‐on to MET + SU, 26 weeks (N = 469) 63 | Pbo | −0.13 | 3.60 | −0.8 | −2.7 |
| Cana 100/300 | −0.85 to −1.06 | −18.02 to −30.63 | −1.9 to −2.5 | −4.3 to −4.9 | |
| Add‐on to MET + TZD (PIO), 26 weeks (+26‐week extension) (N = 342) 64 | Pbo | −0.26 | 2.5 | −0.2 | −1.2 |
| Cana 100/300 | −0.89 to −1.03 | −26.8 to −33.2 | −2.6 to −3.8 | −4.7 to −5.3 | |
|
Add‐on to INS (≥ 30 units/day) ± OADs Substudy efficacy duration 18 weeks (N = 1708) 65 |
Cana 100/300¶ | −0.65 to −0.73¶ | −22.52 to −29.01¶ | −1.9 to −2.4%¶ | −2.6 to −4.4¶ |
| Empagliflozin | |||||
| Monotherapy, 24 weeks (N = 899) 66 | Pbo | 0.08 | 11.7 | −0.33 | −0.3 |
| SITA 100 | −0.66 | −6.85 | 0.18 | 0.5 | |
| Empa 10/25 | −0.66 to −0.78 | −19.5 to −24.5 | −2.26 to −2.48 | −2.9 to −3.7 | |
| Monotherapy (A1c > 10.0), 24 weeks (N = 87) 66 | Empa 25 | −3.70 | −84.3 | −2.43 | −4.0 |
| Add‐on to MET, 24 weeks (N = 637) 67 | Pbo | −0.13 | 6.38 | −0.45 | −0.4 |
| Empa 10/25 | −0.70 to −0.77 | −20.04 to −22.28 | −2.08 to −2.46 | −4.5 to −5.2 | |
| Add‐on to MET + SU, 24 weeks (N = 666) 68 | Pbo | −0.17 | 5.52 | −0.39 | −1.4 |
| Empa 10/25 | −0.77 to −0.82 | −23.27 to −23.30 | −2.16 to −2.39 | −3.5 to −4.1 | |
| Add‐on to TZD (PIO) ± MET, 24 weeks (N = 498) 69 | Pbo | −0.11 | 6.47 | 0.34 | 0.7 |
| Empa 10/25 | −0.59 to 0.72 | −17.0 to −22.0 | −1.47 to −1.62 | −3.1 to −4.0 | |
| Add‐on to MET, 104 weeks (N = 1549) 79 | GLIM 1–4 | −0.55 | −3.06 | 1.3 | 2.5 |
| Empa 25 | −0.66 | −15.32 | −3.1 | −3.1 | |
*All included studies were conducted in adults (≥ 18 years old). †Data for high glycaemic subgroups are presented for monotherapy studies only. ‡Data are presented as reported in each publication; the range of changes shown is for approved doses of the drug only. §Number of patients randomized. ¶Adjusted mean difference from placebo. HbA1c, glycated haemoglobin; FPG, fasting plasma glucose; SBP, systolic blood pressure; Pbo, placebo; Dapa, dapagliflozin; A1c, glycated haemoglobin; MET, metformin; GLIP, glipizide; XR, extended‐release formulation; SU, sulfonylurea; GLIM, glimepiride; DPP4i, dipeptidyl peptidase‐4 inhibitor; SITA, sitagliptin; TZD, thiazolidinedione; INS, insulin; OAD, oral antidiabetes drug; N/r, not reported (in original publication); Cana, canagliflozin; PIO, pioglitazone; Empa, empagliflozin.