Table 1.
Study | NCT number | Year | Sponsor | Active treatment | Comparator | Centres (n) | Patients (n) | Treatment duration (weeks) | |
---|---|---|---|---|---|---|---|---|---|
Core period | Extension period | ||||||||
Bailey [22] | NCT00528879 | 2010 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 80 | 546 | 24 | n.a. |
Bailey [23] | n.a. | 2012 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 63 | 282 | 24 | n.a. |
Barnett [24] | NCT01164501 | 2014 | Boehringer Ingelheim, Eli Lilly | Empagliflozin | Placebo | 127 | 738 | 52 | n.a. |
Bode [25] | NCT01106651 | 2013 | Janssen Research & Development, LLC | Canagliflozin | Placebo | 90 | 716 | 26 | n.a. |
Bolinder [26, 27] | NCT00855166 | 2012, 2014 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 40 | 182 | 24 | 78 |
Cefalu [28] | NCT00968812 | 2013 | Janssen Research & Development, LLC | Canagliflozin | Glimepiride | 157 | 1450 | 52 | n.a. |
Cefalu [29] | NCT01031680 | 2015 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 141 | 922 | 24 | 28 |
Dagogo-Jack [30] | NCT02036515 | 2018 | Merck & Co., Inc. | Ertugliflozin | Placebo | 104 | 462 | 26 | 26 |
DeFronzo [31] | NCT01422876 | 2015 | Boehringer Ingelheim, Eli Lilly | Empagliflozin | Linagliptin | 197 | 686 [413] | 24 | 28 |
Ferdinand [32] | NCT02182830 | 2019 | Boehringer Ingelheim, Eli Lilly | Empagliflozin | Placebo | 92 | 157 | 24 | n.a. |
Ferrannini [33] | NCT00528372 | 2010 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 85 | 559 | 24 | n.a. |
Fioretto [34] | NCT02413398 | 2018 | AstraZeneca, National Institutes of Health | Dapagliflozin | Placebo | 88 | 321 | 24 | n.a. |
Forst [35] | NCT01106690 | 2014 | Janssen Research & Development, LLC | Canagliflozin | Placebo | 74 | 342 | 26 | n.a.a |
Frias [36], Jabbour [37] | NCT02229396 | 2016, 2018 | AstraZeneca | Dapagliflozin | Exenatide | 134 | 694 [463] | 28 | 25 |
Grunberger [38] | NCT01986855 | 2018 | Merck Sharp & Dohme Corp., Pfizer Inc. | Ertugliflozin | Placebo | 121 | 467 | 52 | n.a. |
Hadjadj [39] | NCT01719003 | 2016 | Boehringer Ingelheim, Eli Lilly | Empagliflozin | Metformin | 190 | 1364 [702] | 24 | n.a. |
Haring [40] | NCT01159600 | 2013 | Boehringer Ingelheim | Empagliflozin | Placebo | 148 | 669 | 24 | n.a. |
Haring [41] | NCT01159600 | 2014 | Boehringer Ingelheim | Empagliflozin | Placebo | 148 | 637 | 24 | n.a. |
Henry [42] | NCT00643851 | 2012 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Metformin | 105 | 598 [404] | 24 | n.a. |
Henry [42] | NCT00859898 | 2012 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Metformin | 131 | 638 [427] | 24 | n.a. |
Hollander [43, 44] | NCT01999218 | 2018 | Merck & Co., Inc. | Ertugliflozin | Glimepiride | 232 | 1325 | 52 | 52 |
Inagaki [45] | NCT01413204 | 2014 | Mitsubishi Tanabe Pharma Corporation | Canagliflozin | Placebo | 5 | 272 | 24 | n.a. |
Jabbour [46] | NCT00984867 | 2014 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 88 | 451 | 24 | 24 |
Ji [47] | NCT01095653 | 2014 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 40 | 393 | 24 | n.a. |
Kadowaki [48] | NCT02354235 | 2017 | Mitsubishi Tanabe Pharma Corporation | Canagliflozin | Placebo | 3 | 138 | 24 | n.a. |
Kaku [49] | NCT01294423 | 2014 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 27 | 261 | 24 | n.a. |
Kohan [50] | NCT00663260 | 2014 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 111 | 252 | 24 | 70 |
Kovacs [51, 52] | NCT01210001 | 2014, 2015 | Boehringer Ingelheim | Empagliflozin | Placebo | 69 | 498 | 24 | 52 |
Lavalle-Gonzalez [53] | NCT01106677 | 2013 | Janssen Research & Development, LLC | Canagliflozin | Placebo | 169 | 1284 | 26 | n.a. |
Leiter [54] | NCT01042977 | 2014 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 173 | 965 | 24 | 28 |
Lewin [55] | NCT01422876 | 2015 | Boehringer Ingelheim, Eli Lilly | Empagliflozin | Linagliptin | 197 | 677 [405] | 52 | n.a. |
Mathieu [56, 57] | NCT01646320 | 2015, 2016 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 67 | 320 | 24 | 26 |
Matthaei [58] | NCT01392677 | 2015 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 46 | 218 | 24 | n.a. |
Müller-Wieland [59] | NCT02471404 | 2018 | AstraZeneca | Dapagliflozin | Glimepiride | 194 | 939 [627] | 52 | n.a. |
Nauck [60] | NCT00660907 | 2011 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Glipizide | 95 | 814 | 52 | n.a. |
Neal [4] | NCT01032629, NCT01989754 | 2017 | Janssen Research & Development, LLC | Canagliflozin | Placebo | 667 | 10,142 | 188 | n.a. |
Perkovic [61] | NCT02065791 | 2019 | Janssen Research & Development, LLC | Canagliflozin | Placebo | 690 | 4397 | 136 | n.a. |
Phrommintikul [62] | NCT03178591 | 2019 | Thailand Research Fund, National Science and Technology Development Agency NSTDA | Dapagliflozin | Vildagliptin | 1 | 49 | 24 | n.a. |
Pollock [63] | NCT02547935 | 2019 | AstraZeneca | Dapagliflozin | Placebo | 116 | 448 [296] | 24 | n.a. |
Pratley [64] | NCT02099110 | 2018 | Merck & Co., Inc., Pfizer Inc. | Ertugliflozin | Sitagliptin | 21 | 1232 [745] | 52 | n.a. |
Ridderstrale [65, 66] | NCT01167881 | 2014, 2018 | Boehringer Ingelheim, Eli Lilly | Empagliflozin | Glimepiride | 173 | 1545 | 104 | 104 |
Rodbard [67] | NCT02025907 | 2013 | Janssen Research & Development, LLC | Canagliflozin | Placebo | 47 | 216 | 26 | n.a. |
Roden [68, 69] | NCT01177813, NCT01289990 | 2013, 2015 | Boehringer Ingelheim, Eli Lilly | Empagliflozin | Sitagliptin, placebo | 124 | 899 | 24 | 52 |
Rosenstock [70] | NCT00683878 | 2012 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 105 | 420 | 48 | n.a. |
Rosenstock [71] | NCT01606007 | 2015 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Saxagliptin | 139 | 534 [355] | 24 | n.a. |
Rosenstock [72] | NCT01011868 | 2015 | Boehringer Ingelheim, Eli Lilly | Empagliflozin | Placebo | 97 | 494 | 78 | n.a. |
Rosenstock [73] | NCT01809327 | 2016 | Janssen Research & Development, LLC | Canagliflozin | Metformin | 158 | 1186 [712] | 26 | n.a. |
Rosenstock [74] | NCT02033889 | 2018 | Merck Sharp & Dohme Corp., Pfizer | Ertugliflozin | Placebo | ? | 621 | 26 | n.a.a |
Schernthaner [75] | NCT01137812 | 2013 | Janssen Research & Development, LLC | Canagliflozin | Sitagliptin | 140 | 755 | 52 | n.a. |
Scott [76] | NCT02532855 | 2018 | Merck & Co., Inc. | Dapagliflozin | Sitagliptin | 185 | 614 | 24 | n.a. |
Softeland [77] | NCT01734785 | 2017 | Boehringer Ingelheim, Eli Lilly | Empagliflozin | Placebo | 90 | 332 | 24 | n.a. |
Stenlof [78] | NCT01081834 | 2013 | Janssen Research & Development, LLC | Canagliflozin | Placebo | 79 | 584 | 26 | n.a.a |
Strojek [79, 80] | NCT00680745 | 2011, 2014 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 84 | 596 | 24 | 24 |
Terra [81] | NCT01958671 | 2017 | Pfizer, Inc., Merck & Co., Inc. | Ertugliflozin | Placebo | 67 | 461 | 26 | n.a. a |
Wilding [82, 83] | NCT00673231 | 2012, 2014 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 126 | 807 | 24 | 80 |
Wilding [84] | NCT01106625 | 2013 | Janssen Research & Development, LLC | Canagliflozin | Placebo | 85 | 469 | 26 | 26 |
Wiviott [5] | NCT01730534 | 2019 | AstraZeneca | Dapagliflozin | Placebo | 882 | 17,160 | 218 | n.a. |
Yale [85] | NCT01064414 | 2013 | Janssen Research & Development, LLC | Canagliflozin | Placebo | 89 | 269 | 26 | n.a. |
Yang [86] | NCT01095666 | 2016 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 32 | 444 | 24 | n.a. |
Yang [87] | NCT02096705 | 2018 | AstraZeneca | Dapagliflozin | Placebo | 28 | 272 | 24 | n.a. |
Zinman [6] | NCT01131676 | 2015 | Boehringer Ingelheim, Eli Lilly | Empagliflozin | Placebo | 590 | 7020 | 164 | n.a. |
AstraZeneca | NCT00736879 | Bristol-Myers Squibb, AstraZeneca | Dapagliflozin | Placebo | 62 | 282 | 24 | n.a. | |
AstraZeneca | NCT02681094 | AstraZeneca | Dapagliflozin | Saxagliptin | 119 | 883 [590] | 24 | n.a. | |
Merck Sharp & Dohme Corp. | NCT02630706 | Merck Sharp & Dohme Corp., Pfizer | Ertugliflozin | Placebo | 50 | 506 | 26 | n.a. |
aDuring the extension period of the trial, patients on placebo or active control changed their treatment. Therefore, only the core period of the respective trial was considered for analyses. n.a., not available. Numbers in brackets show the number of patients available for endpoint analyses (if different to the total number of patients included in the respective trial)