Table 1

Basic characteristics of the included RCTs

StudyTreatmentsNParticipants’ characteristics*Weeks (max)Findings
AgeHbA1c (%)BMI or weight (kg/m2 or kg†)FPG (mmol/L or mg/dL‡)
Bailey et al20PLA13753.7 (10.3)8.11 (0.96)31.8 (5.3)9.19 (2.57)24Dapagliflozin+metformin enhanced glycaemic
control and lowered body weight
2.5 mg DAPA13755 (9.3)7.99 (0.90)31.6 (4.8)8.96 (2.39)
5 mg DAPA13754.3 (9.4)8.17 (0.96)31.4 (5.0)9.39 (2.72)
10 mg DAPA13552.7 (9.9)7.92 (0.82)31.2 (5.1)8.66 (2.15)
Bailey et al21PLA+MET137NA8.12 (0.96)87.74 (19.24)†9.19 (2.58)102Dapagliflozin+metformin for 102 weeks
enhanced glycaemic control and lowered body weight
2.5 mg DAPA+MET137NA7.99 (0.90)84.90 (17.77)†8.96 (2.39)
5 mg DAPA+MET137NA8.17 (0.96)84.73 (16.26)†9.39 (2.72)
10 mg DAPA+MET135NA7.92 (0.82)86.28 (17.53)†8.66 (2.15)
Bolinder et al 22PLA+MET9160.8 (6.9)8.11 (0.96)31.7 (3.9)8.3 (1.4)24Dapagliflozin+metformin reduced total body weight
10 mg DAPA+MET8960.6 (8.2)7.99 (0.90)32.1 (3.9)8.2 (1.4)
Bolinder et al23PLA+MET91NA7.1690.9†8.21102Dapagliflozin+metformin enhanced
glycaemic control and reduced body weight
10 mg DAPA+MET91NA7.1992.1†8.3
Henry et al24Study 124Dapagliflozin+metformin was effective in
reducing HbA1c, FPG and weight
5 mg DAPA+PLA20352.3 (10.2)9.1 (1.4)86.2 (21.1)†10.59 (3.14)
MET+PLA20151.8 (9.8)9.2 (1.3)85.6 (20.0)†10.94 (3.53)
5 mg DAPA+MET19451.7 (9.3)9.2 (1.3)84.1 (19.5)†10.76 (3.12)
Study 2
10 mg DAPA+PLA21951.1 (11. 5)9.1 (1.3)88.5 (19.3)†10.99 (3.43)
MET+PLA20852.7 (10.4)9.1 (1.3)87.2 (19.4)†10.57 (3.00)
10 mg DAPA+MET21151.0 (10.1)9.1 (1.3)88.4 (19.7)†10.52 (3.22)
Ljunggren et al25PLA+MET9160.8 (6.9)7.16 (0.53)31.7 (3.9)8.3 (1.4)50Dapagliflozin+metformin did not affect markers of
bone formation and resorption
10 mg DAPA+MET8960.6 (8.2)7.19 (0.44)32.1 (3.9)8.2 (1.4)
Rosenstock et al26≥30 mg PIO+PLA13953.5 (11.4)8.34 (1.00)NA8.92 (2.61)48Dapagliflozin+pioglitaz one further enhanced glycaemic control without pioglitazone-related body weight gain
≥30 mg PIO+5 mg DAPA14153.2 (10.9)8.40 (1.03)NA9.36 (2.98)
≥30 mg PIO+10 mg DAPA14053.8 (10.4)8.37 (0.96)NA9.15 (2.57)
Strojek et al27PLA+GLI14560.3(10.16)8.15 (0.74)NA9.58 (2.07)24Dapagliflozin+glimepiride significantly enhanced glycaemic control and reduced body weight
2.5 mg DAPA+GLI15459.9 (10.14)8.11 (0.75)NA9.56 (2.13)
5 mg DAPA+GLI14260.2 (9.73)8.12 (0.78)NA9.68 (2.12)
10 mg DAPA+GLI15158.9 (8.32)8.07 (0.79)NA9.55 (2.04)
Wilding, et al28PLA+INS2358.4 (6.5)8.4 (0.9)34.8 (4.6)165.9 (51.5)‡12Dapagliflozin+insulin improved glycaemic control and lowered body weight
10 mg DAPA+INS2455.7 (9.2)8.4 (0.7)35.5 (3.6)156.0 (39.0)‡
20 mg DAPA+INS2456.1 (10.6)8.5 (0.9)36.2 (4.6)161.6 (55.0)‡
Wilding, et al29PLA+INS19358.8 (8.6)8.47 (0.77)33.1 (5.9)9.5 (3.2)48Dapagliflozin+insulin enhanced glycaemic control, stabilised insulin dosing and lowered body weight
2.5 mg DAPA+INS202 59.8 (7.6)8.46 (0.78)33.0 (5.0)10.0 (3.3)
5 mg DAPA+INS21159.3 (7.9)8.62 (0.89)33.0 (5.3)10.3 (3.3)
10 mg DAPA+INS194 59.3 (8.8)8.57 (0.82)33.4 (5.1)9.6 (3.0)
Wilding et al30PLA+INS19358.8 (8.6)8.47 (0.77)33.1 (5.9)9.5 (3.2)104Dapagliflozin+insulin enhanced glycaemic control, stabilised insulin dosing and lowered body weight, but elevated rates of genital infection and of UTI
2.5 mg DAPA+INS20259.8 (7.6)8.46 (0.78)33.0 (5.0)10.0 (3.3)
5/10 mg DAPA+INS21159.3 (7.9)8.62 (0.89)33.0 (5.3)10.3 (3.3)
10 mg DAPA+INS19459.3 (8.8)8.57 (0.82)33.4 (5.1)9.6 (3.0)
Jabbour et al31§PLA+MET/SIT22455.0 (10.20)7.97 (0.79)89.23 (20.89)†162.97 (34.45) ‡24 
10 mg DAPA+MET/SIT22354.8 (10.42)7.90 (0.81)91.02 (21.64)†162.19 (36.83) ‡
  • *Measured by mean (SD).

  • †Meansured by weight (kg) .

  • ‡Meansured by mg/dL.

  • §The data were extracted from ClinicalTrial.gov due to unavailability of final report.

  • BMI, body mass index; DAPA, dapagliflozin; FPG, fasting plasma glucose; GLI, glimepiride; HbA1c, glycosylated haemoglobin; INS, insulin; MET, metformin; NA, not applicable; PIO, pioglitazone; PLA, placebo; RCT, randomised controlled trial; SIT, sitagliptin.