Table 1

Summary of studies included. Data are number (%) of participants unless stated otherwise

Trial NoPublicationNo of participantsPlaceboCanagliflozinMean (SD) age
(years)
Female sexDuration of placebo comparison (months)Primary outcomeSpecific criteriaGlycaemic controlPrevious treatment
NCT00642278*Rosenstock et al 20122638665 (16.8)321 (83.2)53 (8)188 (48.7)12Change in HbA1c from baselineInadequate glycaemic controlMetformin monotherapy
NCT01340664Qiu et al 20142727993 (33.3)186 (66.7)56 (9.5)149 (53.4)18Change in HbA1c from baselineInadequate glycaemic controlMetformin monotherapy
NCT01106625Wilding et al 201328469156 (33.3)313 (66.7)57 (9.3)230 (49)52Change in HbA1c from baselineInadequate glycaemic controlMetformin plus sulphonylurea
NCT01064414Yale et al 20132926990 (33.5)179 (66.5)68 (8.2)106 (39.4)52Change in HbA1c from baselineStage 3 chronic kidney diseaseInadequate glycaemic controlNo treament or stable American Heart Association regimen
NCT01081834Stenlöf et al 201330678194 (28.6)484 (71.4)54 (10.8)376 (55.5)26Change in HbA1c from baselineInadequate glycaemic controlDiet and exercise
NCT01106677†Lavalle-González et al 201312918183 (19.9)735 (80.1)55 (9.4)485 (52.8)26Change in HbA1c from baselineInadequate glycaemic controlMetformin monotherapy
NCT01032629Neal et al 20171543301442 (33.3)2888 (66.7)61 (8.1)1469 (33.9)> 52Onset of MACEsHigh cardiovascular riskHBA1c≥7.0% and ≤10.5%
NCT01106651Bode et al 201313716239 (33.4)477 (66.6)64 (6.3)320 (44.7)26Change in HbA1c from baselineOlder patients (aged 55-80 years)Inadequate glycaemic controlMetformin, sulfonylurea, dipeptidyl peptidase 4 inhibitor, α-glucosidase inhibitor, glucagon-like peptide 1 agonist, or insulin or pioglitazone
NCT01106690Forst et al 201431342115 (33.6)227 (66.4)57 (10)126 (36.8)26Change in HbA1c from baselineInadequate glycaemic controlMetformin and pioglitazone
NCT01381900Ji et al 201514676226 (33.4)450 (66.6)49 (10.1)314 (46.4)18Change in HbA1c from baselineAsian patients‡Inadequate glycaemic controlMetformin or metformin+sulphonylurea
NCT01989754Neal et al 20171558132906 (50)2907 (50)62 (8.4)2164 (37.2)>52Onset of MACEHigh cardiovascular riskHbA1c≥7.0% and ≤10.5%
NCT02025907Rodbard et al 201632218109 (50)109 (50)57 (9.7)92 (42.2)26Change in HbA1c from baselineInadequate glycaemic controlMetformin and sitagliptin
Total15 0945818 (38.5)9276 (61.5)60 (9.4)6019 (39.9)
  • SD=standard deviation; HbA1c=serum glycated haemoglobin; MACE=major adverse cardiovascular events.

  • *In this study, 65 additional patients were randomised in an active comparator arm (sitaglipin) but were not included in our analyses.

  • †In this study, 366 additional patients were randomised in an active comparator arm (sitaglipin) but were not included in our analyses.

  • ‡Study group includes Chinese and other Asian patients; the study was conducted in China, Malaysia, and Vietnam.