Table 1 Characteristics of included RCTs
Study (trial name) | Study design (NCT number) | Mean age (SD) | Health conditions | Number of patients | Interventions | Background hypoglycaemic therapy | Mean follow-up (weeks) | |||
|---|---|---|---|---|---|---|---|---|---|---|
Treatment | Control | Treatment (Female/male) | Control (Female/male) | Female (%) | ||||||
Dapagliflozin | ||||||||||
Wilding et al. [22] | RCT (NCT00673231) | 59.5 ± 8.1 | 58.8 ± 8.6 | Type 2 diabetes mellitus | 607 (320/287) | 193 (98/95) | 52.2 | Dapagliflozin (2.5/5/10 mg) Matching placebo | Insulin | 48 |
Bailey et al. [28] | RCT (NCT00528879) | 53.7 (NA) | 54.0 (NA) | Type 2 diabetes mellitus | 409 (194/215) | 137 (62/75) | 46.9 | Dapagliflozin (2.5/5/10 mg) Matching placebo | Metformin | 102 |
Leiter et al. [21] | RCT (NCT01042977) | 63.9 ± 7.6 | 63.6 ± 7.0 | Type 2 diabetes mellitus Cardiovascular disease | 480 (159/321) | 482 (159/323) | 33.1 | Dapagliflozin (10 mg) Matching placebo | Insulin | 24 |
Mathieu et al. [29] | RCT (NCT016 6320) | 55.2 ± 8.6 | 55.0 ± 9.6 | Type 2 diabetes mellitus | 160 (90/70) | 160 (84/76) | 54.4 | Dapagliflozin (10 mg) Matching placebo | Metformin saxagliptin | 24 |
NCT00528372 (2015) | RCT (NCT00528372) | NA | NA | Type 2 diabetes mellitus | 410 (212/198) | 75 (44/31) | 52.7 | Dapagliflozin (2.5/5/10 mg) Matching placebo | Metformin | 102 |
NCT01730534 (2019) DARELARE-TIMI58 | RCT (NCT01730534) | 63.9 ± 6.8 | 64.0 ± 6.8 | Type 2 diabetes mellitus Cardiovascular disease | 8582 (3171/5411) | 8578 (3251/5327) | 37.4 | Dapagliflozin (10 mg) Matching placebo | Metformin Insulin Sulfonylurea DPP-4i GLP-1 receptor agonist | 202 |
Canagliflozin | ||||||||||
Wilding et al. [23] CANTATA-MSU Trial | RCT (NCT01106625) | 56.8 ± 9.7 | 56.7 ± 8.3 | Type 2 diabetes mellitus | 313 (150/163) | 156 (80/76) | 49 | Canagliflozin (100/300 mg) matching placebo | Metformin Suiphonylurea | 52 |
Yale et al. [24] | RCT (NCT01064414) | 68.7 ± 8.2 | 68.2 ± 8.4 | Type 2 diabetes mellitus Chronic kidney disease | 179 (73/106) | 90 (33/57) | 36.1 | Canagliflozin (100/300 mg) Matching placebo | Insulin Sulphonylurea | 52 |
Bode et al. [30] | RCT (NCT01106651) | 63.9 ± 6.2 | 63.2 ± 6.2 | Type 2 diabetes mellitus | 477 (224/253) | 237 (94/143) | 44.5 | Canagliflozin (100/300 mg) Matching placebo | Insulin Sulphonylurea | 104 |
NCT01989754 (2018) CANVAS-R Trial | RCT (NCT01989754) | 63.9 ± 8.42 | 64 ± 8.28 | Type 2 diabetes mellitus Chronic kidney disease | 2904 (1111/1794) | 2903 (1053/1854) | 37.3 | Canagliflozin (100/300 mg) Matching placebo | Metformin Insulin Sulfonylurea DPP-4i GLP-1 receptor agonist | 187 |
NCT01032629 (2018) CANVAS Trial | RCT (NCT01032629) | 62.5 ± 8.1 | 62.3 ± 7.9 | Type 2 diabetes mellitus Cardiovascular Diseases | 2888(983/1905) | 1442(486/956) | 33.9 | Canagliflozin (100/300 mg) Matching placebo | Metformin Insulin Sulfonylurea DPP-4i GLP-1 receptor agonist | 202 |
Perkovic et al. [7] CREDENCE Trial | RCT (NCT02065791) | 62.9 ± 9.2 | 63.2 ± 9.2 | Type 2 diabetes mellitus Chronic kidney disease | 2202(762/1440) | 2199(732/1467) | 33.9 | Canagliflozin (100 mg) Matching placebo | Metformin Insulin Sulfonylurea DPP-4i GLP-1 receptor agonist | 125 |
Empagliflozin | ||||||||||
Kovacs et al. [27] | RCT (NCT01210001) | 54.5 ± 9.4 | 54.6 ± 10.5 | Type 2 diabetes mellitus | 333 (165/168) | 165(92/73) | 51.6 | Empagliflozin (10/25 mg) Matching placebo | Metformin Pioglitazone | 24 |
Barnett et al. [31] | RCT (NCT01164501) | 63.7 ± 8.9 | 64.1 ± 8.7 | Type 2 diabetes mellitus Chronic kidney disease | 419 (170/249) | 319 (138/181) | 41.7 | Empagliflozin (10/25 mg) Matching placebo | Metformin Pioglitazone Insulin | 52 |
Rosenstock et al. [25] | RCT (NCT01011868) | 59.2 (NA) | 58.1(NA) | Type 2 diabetes mellitus | 324 (138/186) | 170 (80/90) | 42.4 | Empagliflozin (10/25 mg) Matching placebo | Insulin | 78 |
NCT01734785 (2016) | RCT (NCT01734785) | 54.9 ± 9.7 | 55.9 ± 9.6 | Type 2 diabetes mellitus | 222 (85/137) | 110 (49/61) | 40.4 | Empagliflozin (10/25 mg) Matching placebo | Metformin | 24 |