Table 1

Study characteristics and outcomes (results reported for the end of the main study duration)

Study designParticipantsInterventionsOutcomes
DapagliflozinDifference 10 mg dapagliflozin versus control (95% CI)
Bailey et al8N: 534Intervention: 2.5, 5 or 10 mg dapagliflozin once dailyHbA1c (%): −0.54 (−0.74 to −0.34)
 Design: multicentre (n=80), 4-arm, double-blind, placebo-controlled RCTAge (years): 54–55 SD 9–10Comparator: placeboWeight (kg): −2.00 (−2.67 to −1.33)
 Duration: 24 weeksHbA1c (%): 7.9–8.2 SD 0.8–1.00Background antidiabetic therapy: metformin (≥1500 mg/day)FPG (mmol/l): −0.97 (95% CI NR)
 Follow-up: 102 weeksBMI (kg/m2): 31.2–31.8 SD 5.4–6.2SBP (mm  Hg): −4.9 (95% CI NR)
 Quality: high
Bolinder et al9 10N: 180Intervention: 10 mg dapagliflozin once dailyHbA1c (%):−0.29 (−0.42 to −0.16)
Design: multicentre (n=40), 2-arm, double-blind, placebo-controlled RCTAge (years): 61 SD 7–8Comparator: placeboWeight (kg): −2.08 (−2.84 to −1.32)
Duration: 24 weeksHbA1c (%): 7.2 SD 0.4–0.5Background antidiabetic therapy: metformin (≥1500 mg/day)FPG (mmol/L): −0.95 (−1.33 to −0.57)
Follow-up: 78 week extensionBMI (kg/m2): 31.7–32.1 SD 3.9SBP (mm Hg): −2.8 (−5.9 to 0.2)
Quality: high
Nauck et al11N: 801Intervention: dapagliflozin once daily (mean dose 9.2 mg)HbA1c (%): 0.0 (−0.11 to +0.11)
Design: multicentre (n=95), 2-arm, double-blind, active-controlled RCTAge (years): 58–59 SD 9–10Comparator: glipizide (mean dose 16.4 mg)Weight (kg): −4.66 (−5.15 to −4.17)
Duration: 52 weeksHbA1c (%): 7.7 SD 0.9Background antidiabetic therapy: metformin (≥1500 mg/day)FPG (mmol/l): −0.20 (95% CI NR)
Follow-up: 156 week extensionBMI (kg/m2): 31.2–31.7 SD 5.1SBP (mm  Hg): −5.1 (95% CI NR)
Quality: high
Rosenstock et al12N: 420Intervention: 5 or 10 mg dapagliflozin once dailyHbA1c (%):−0.55 (−0.71 to −0.39)
Design: multicentre (n=105), 3-arm, double-blind, placebo-controlled RCTAge (years): 53–54 SD 10–11Comparator: placeboWeight (kg): −1.78 (−2.32 to −1.24)
Duration: 24 weeksHbA1c (%): 8.3–8.4 SD 1.0Background antidiabetic therapy: pioglitazone (30 or 45 mg/day)FPG (mmol/l): −1.33 (95% CI NR)
Follow-up: 24 week extensionBMI (kg/m2): 51–62% ≥30; 87–93% ≥25SBP (mm  Hg): −4.7 (95% CI NR)
Quality: low
Strojek et al13N: 592Intervention: 2.5, 5 or 10 mg dapagliflozin once dailyHbA1c (%):−0.69 (−0.87 to −0.51)
Design: multicentre (n=84), 4-arm, double-blind, placebo-controlled RCTAge (years): 59–60 SD 8–10Comparator: placeboWeight (kg): −1.54 (−1.88 to −1.20)
Duration: 24 weeksHbA1c (%): 8.1 SD 0.7–0.8Background antidiabetic therapy: glimepiride (4 mg)FPG (mmol/l): −1.47 (−1.86 to −1.08)
Follow-up: 24 week extensionBMI (kg/m2): 45–51% ≥30; 80–86% ≥25SBP (mm Hg): −3.8 (−6.4 to −1.2)
Quality: high
Wilding et al14N: 71Intervention: 10 or 20 mg dapagliflozin once dailyHbA1c (%):−0.70 (−1.07 to −0.33)
Design: multicentre (n=26), 3-arm, double-blind, placebo-controlled RCTAge (years): 56–58 SD 7–11Comparator: placeboWeight (kg): −2.60 (−3.94 to −1.26)
Duration: 12 weeksHbA1c (%): 8.4–8.5 SD 0.7–0.9Background antidiabetic therapy: insulin (51–56 U)+OAD (≤79% metformin only, ≤25% metformin plus TZD, ≤12.5% TZD only)FPG (mmol/l): −0.86 (−2.13 to +0.42)
Follow-up: 4 weeksBMI (kg/m2): 34.8–36.2 SD 3.6–4.6SBP (mm Hg): NR
Quality: medium
Wilding et al15N: 800Intervention: 2.5, 5 or 10 mg dapagliflozin once dailyHbA1c (%):−0.57 (−0.67 to −0.40)
Design: multicentre (n=126), 4-arm, double-blind, placebo-controlled RCTAge (years): 59–60 SD 8–9Comparator: placeboWeight (kg): −2.04 (−2.57 to −1.51)
Duration: 24 weeksHbA1c (%): 8.5–8.6 SD 0.8–0.9Background antidiabetic therapy: insulin (77.1 U) ± OAD (∼50% none, ∼40% metformin only, rest combination)FPG (mmol/l): NR
Follow-up: 24+56 week extensionBMI (kg/m2): 33.0–33.4 SD 5.0–5.9SBP (mm  Hg): −3.11 (−5.79 to −0.43)
Quality: high
CanagliflozinDifference versus active/placebo (95% CI)
Rosenstock et al16N: 451Intervention: 50, 100, 200 or 300 mg once daily or 300 mg twice daily canagliflozinHbA1c (%): −0.48–−0.73 vs placebo; +0.04–−0.21 vs sitagliptin (95% CI NR)
Design: multicentre (n=85), 7-arm, double-blind, placebo-controlled and active-controlled RCTAge (years): 52.9 SD 8.1Comparator 1: placeboWeight (kg): −1.2–−2.3 vs placebo; −1.7–−2.8 vs sitagliptin (95% CI NR)
Duration: 12 weeksHbA1c (%): 7.75 SD 0.93Comparator 2: 100 mg once daily sitagliptinFPG (mmol/l): −1.1–−1.7 vs placebo; −0.2–−0.8 vs sitagliptin (95% CI NR)
Follow-up: 2 weeksBMI (kg/m2): 31.5 SD 4.9Background antidiabetic therapy: metformin (≥1500 mg)SBP (mm Hg): +2.3–−3.6 vs placebo; +1.8–−4.1 vs sitagliptin (95% CI NR) (roughly proportional to dose, but no advantage of 300 mg twice daily vs once daily)
Quality: medium
  • BMI, body mass index; FPG, fasting plasma glucose; OAD, oral anti-diabetes drugs; RCT, randomised controlled trial; SBP, systolic blood pressure; TZD, thiazolidinedione.