Table 2.
Glycemic efficacy of dapagliflozin when used in combination therapy in patients with type 2 diabetes mellitus
| Study | Intervention | Mean change from baseline HbA1c, % | Mean change from baseline bodyweight (kg) | ||
|---|---|---|---|---|---|
| To end of main study | To end of extension | To end of main study | To end of extension | ||
| Metformin studiesa | |||||
| Bailey et al. [50] | Placebo (n = 137; 73) | −0.30 | 0.02 | −0.9 | 1.4 |
| Bailey et al. [51] (24 weeks; 102 weeks) | |||||
| Dapagliflozin 2.5 mg (n = 137; 82) | −0.67† | −0.48† | −2.2‡ | −1.1‡ | |
| Dapagliflozin 5 mg (n = 137; 89) | −0.70‡ | −0.58‡ | −3.0‡ | −1.7‡ | |
| Dapagliflozin 10 mg (n = 135; 95) | −0.84‡ | −0.78‡ | −2.9‡ | −1.7‡ | |
| Nauck et al. [53] | Dapagliflozin ≤10 mg (n = 400; 161) | −0.52 | −0.10 | −3.2‡ | −4.0 |
| Del Prato et al. [56] (52 weeks; 4 years) | |||||
| Glipizide ≤20 mg (n = 401; 141) | −0.52 | 0.2 | 1.4 | 1.1 | |
| Bolinder et al. [28] | Placebo (n = 91; 49) | −0.10 | −0.12 | −0.88‡ | −2.12 |
| Bolinder et al. [52] (24 weeks; 2 years) | |||||
| Dapagliflozin 10 mg (n = 89; 60) | −0.39‡ | −0.30 | −2.96 | −4.54 | |
| Matthaei et al. [57] | Placebo (n = 108) | −0.17 | – | −0.6 | – |
| Dapagliflozin 10 mg (n = 108) | −0.86‡ | – | −2.7‡ | – | |
| Schumm-Draeger et al. [55] | Placebo (n = 101) | −0.30 | – | −1.04 | – |
| Dapagliflozin 2.5 mg bd (n = 100) | −0.52* | – | −2.84‡ | – | |
| Dapagliflozin 10 mg bd (n = 99) | −0.65‡ | – | −3.2‡ | – | |
| Dapagliflozin 10 mg od (n = 99) | −0.59† | – | −2.76‡ | – | |
| Insulin studiesb | |||||
| Zhang et al. [60] | Placebo (n = 49) | −0.20 | – | −0.95 | – |
| Intensive insulin therapy ± insulin sensitizers at baseline | (patients with early-stage disease) | ||||
| Dapagliflozin 10 or 20 mg (n = 102) | −0.70† (10 mg) | – | −2.00 (10 mg) | – | |
| (patients with early-stage disease) | −0.50† (20 mg) | −2.50 (20 mg) | |||
| Placebo (n = 14) | 0 | – | −1.55 | – | |
| (patients with late-stage disease) | |||||
| Dapagliflozin 10 or 20 mg (n = 44) | −0.60† (10 mg) | – | −4.30 (10 mg) | – | |
| (patients with late stage disease) | −0.80† (20 mg) | −5.05 (20 mg) | |||
| Wilding et al. [58, 61] | Placebo (n = 193; 108) | −0.39 | −0.43 | 0.4 | 1.8 |
| Insulin therapy ± oral antihyperglycemic drugs at baseline (24 weeks; 2 years) | |||||
| Dapagliflozin 2.5 mg (n = 202; 134) | −0.79† | −0.64* | −0.9† | −1.0‡ | |
| Dapagliflozin 5 or 10 mg (n = 211; 129) | −0.89† | −0.82† | −1.0† | −1.0‡ | |
| Dapagliflozin 10 mg (n = 194; 142) | −0.96† | −0.78† | −1.6† | −1.5‡ | |
Key studies and their extensions
bd twice daily, HbA 1c glycosylated hemoglobin, od once daily
* P < 0.05 vs. placebo, ** P < 0.01 vs. placebo, † P < 0.001 vs. placebo, ‡ P < 0.0001 vs. placebo. Not all studies reported P values
aAll patients were receiving metformin therapy
bAll patients were receiving insulin therapy