Table 1.
Characteristics of the randomized controlled studies (RCTs) included in the meta-analysis.
| Author | Trial identifier | Study |
Intervention | Control | Patients (n) |
Age (years) |
Duration of T2DM (years) |
HbA1c (%) |
Case of OH |
|||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Duration | Intervention | Controls | Intervention | Controls | Intervention | Controls | Intervention | Controls | Intervention | Controls | ||||
| Bailey et al.24 | NCT00528879 | 24 weeks | DAPA 2.5 mg,5 mg, | PLA | 137,137,135 | 137 | 55 ± 9.3, 54.3 ± 9.4, | 53.7 ± 10.3 | 6 ± 6.2, 6.4 ± 5.8, | 5.8 ± 5.1 | 7.99 ± 0.9, 8.17 ± 0.96, | 8.11 ± 0.96 | 0,2,0 | 1 |
| 10 mg | 52.7 ± 9.9 | 6.1 ± 5.4 | 7.92 ± 0.82 | |||||||||||
| Cefalu et al.16 | NCT00968812 | 52 weeks | CANA 100 mg,300 mg | GLIM 8 mg | 483,485 | 482 | 56.4 ± 9.5, 55.8 ± 9.2 | 56.3 ± 9.0 | 6.5 ± 5.5, 6.7 ± 5.5 | 6.6 ± 5.0 | 7.8 ± 0.8, 7.8 ± 0.8 | 7.8 ± 0.8 | 0,1 | 0 |
| Lavalle-Gonzalez et al.17 | NCT01106677 | 52 weeks | CANA 100 mg,300 mg | SITA | 368,367 | 366 | 55.5 ± 9.4, 55.3 ± 9.2 | 55.5 ± 9.6 | 6.7 ± 5.4, 7.1 ± 5.4 | 6.8 ± 5.2 | 7.9 ± 0.9, 7.9 ± 0.9 | 7.9 ± 0.9 | 0,0 | 1 |
| 100 mg | ||||||||||||||
| Schernthaner et al.25 | NCT01137812 | 52 weeks | CANA 300 mg | SITA | 377 | 378 | 56.6 ± 9.6 | 56.7 ± 9.3 | 9.4 ± 6.1 | 9.7 ± 6.3 | 8.1 ± 0.9 | 8.1 ± 0.9 | 0 | 1 |
| 100 mg | ||||||||||||||
| Stenlof et al.26 | NCT01081834 | 26 weeks | CANA 100 mg,300mg | PLA | 195,197 | 192 | 55.1 ± 10.8, 55.3 ± 10.2 | 55.7 ± 10.9 | 4.5 ± 4.4, 4.3 ± 4.7 | 4.2 ± 4.1 | 8.1 ± 1.0, 8.0 ± 1.0 | 8.0 ± 1.0 | 0,2 | 0 |
| Bode et al.27 | NCT01106651 | 26 weeks | CANA 100 mg,300 mg | PLA | 241,236 | 237 | 64.3 ± 6.5, 63.4 ± 6.0 | 63.2 ± 6.2 | 12.3 ± 7.8, 11.3 ± 7.2 | 11.4 ± 7.3 | 7.8 ± 0.8, 7.7 ± 0.8 | 7.8 ± 0.8 | 2,1 | 0 |
| Inagaki et al.28 | NCT01413204 | 24 weeks | CANA 100 mg,200 mg | PLA | 90,88 | 93 | 58.4 ± 10.4, 57.4 ± 11.1 | 58.2 ± 11.0 | 4.72 ± 4.59, 5.88 ± 5.93 | 5.63 ± 5.76 | 7.98 ± 0.73, 8.04 ± 0.77 | 8.04 ± 0.70 | 0,2 | 0 |
| Kaku et al.29 | JapicCTI-101349 | 24 weeks | TOFO 10 mg, 20 mg, | PLA | 57,58,58 | 56 | 58.6 ± 9.8, 56.6 ± 10.2, | 56.8 ± 9.9 | 6.3 ± 7.1, 6.4 ± 5.1, | 6.0 ± 6.1 | 8.45 ± 0.75, 8.34 ± 0.81, | 8.41 ± 0.78 | 0,0,1 | 0 |
| 40 mg | 57.0 ± 9.1 | 6.7 ± 5.5 | 8.37 ± 0.77 | |||||||||||
| Yale et al.30 | NCT01064414 | 26 weeks | CANA 100 mg,300 mg | PLA | 90,89 | 90 | 69.5 ± 8.2, 67.9 ± 8.2 | 68.2 ± 8.4 | 15.6 ± 7.4, 17.0 ± 7.8 | 16.4 ± 10.1 | 7.9 ± 0.9, 8.0 ± 0.8 | 8.0 ± 0.9 | 0,1 | 0 |
| Matthaei et al.31 | NCT01392677 | 24 weeks | DAPA 10 mg | PLA | 109 | 109 | 61.1 ± 9.7 | 60.9 ± 9.2 | 9.3 ± 6.5 | 9.6 ± 6.2 | 8.08 ± 0.91 | 8.24 ± 0.87 | 1 | 0 |
| Tikkanen et al.18 | NCT01370005 | 12 weeks | EMPA 10 mg, 25 mg | PLA | 276,276 | 271 | 60.6 ± 8.5, 59.9 ± 9.7 | 60.3 ± 8.8 | NR | NR | 7.87 ± 0.77, 7.92 ± 0.72 | 7.90 ± 0.72 | 0,0 | 1 |
| Bailey et al.32 | NCT00528372 | 102 weeks | DAPA 2.5 mg, 5 mg | PLA | 65,64,70 | 75 | 53.0 ± 11.7, 52.6 ± 10.9, | 52.7 ± 10.3 | 2.1 ± 3.2, 1.0 ± 1.6, | 2.1 ± 3.1 | 7.92 ± 0.9, 7.86 ± 0.94, | 7.84 ± 0.87 | 0,0,1 | 1 |
| 10 mg | 50.6 ± 10.0 | 2.3 ± 3.7 | 8.01 ± 0.96 | |||||||||||
| Wan Seman et al.15 | NR | 12 weeks | DAPA 10 mg | SU | 58 | 52 | 53 ± 9.1 | 56 ± 9.1 | 5.0 (3.0, 9.0)* | 6.0 (3.0, 10.3)* | 7.7 (7.08, 8.43)* | 7.6 (6.9, 8.1)* | 11 | 5 |
| Weber et al.19 | NCT01137474 | 12 weeks | DAPA 10 mg | PLA | 302 | 311 | 55.6 ± 8.4 | 56.2 ± 8.9 | 8.2 ± 6.4 | 7.6 ± 6.2 | 8.1 ± 1.0 | 8.0 ± 0.9 | 1 | 0 |
| Inoue et al.33 | UMIN000018839 | 24 weeks | IPRA 50 mg | PLA | 24 | 24 | 60.5 ± 9.8 | 60.8 ± 12.1 | 15.9 ± 7.7 | 19.1 ± 10.7 | 8.12 ± 0.93 | 8.30 ± 0.65 | 1 | 0 |
| McMurray et al.34 | NCT03036124 | 72.8 weeks | DAPA 10 mg | PLA | 2373 | 2371 | 66.2 ± 11.0 | 66.5 ± 10.8 | NR | NR | NR | NR | 2 | 5 |
BMI: body mass index; HbA1c: glycated hemoglobin; IQR: interquartile range; s.d.: standard deviation; DAPA: dapagliflozin; CANA: canagliflozin; IPRA: ipragliflozin; TOFO: tofogliflozin; EMPA: empagliflozin; PLA: placebo; GLIM: glimepiride; SITA: sitagliptin; SU: sulphonylurea; NR: not report.
Data are number of patients (n) or mean (sd) unless stated otherwise.
*
Median (IQR).