Table 1 Characteristics of included studies.
Study | ClinicalTrials.gov Identifier | Location | Blind | Phase | Follow up (years) | Mean age (years) | Male (%) | Total subject | Treatment | Control |
|---|---|---|---|---|---|---|---|---|---|---|
AWARD-2 45 | NCT01075282 | Multicenter | Open label | phase III | 1.5 | 56.66 | 51.3 | 807 | Dulaglutide 0.75–1.5 mg QW for 78 weeks (n = 545) | Insulin SC once daily for 78 weeks; dose titration based on blood glucose measures (n = 262) |
AWARD-4 46 | NCT01191268 | Multicenter | Open label | phase III | 1 | 59.36 | 53.5 | 884 | Dulaglutide 0.75–1.5 mg QW for 52 weeks (n = 588) | Insulin SC once daily for 52 weeks; dose titration based on blood glucose measures (n = 296) |
LEAD-3 47 | NCT00294723 | Multicenter | Double blind | phase III | 2 | 53 | 49.7 | 745 | Liraglutide 1.8 mg QD for 104 weeks (n = 497) | Glimepiride 8 mg QD for 104 weeks (n = 248) |
Nauck, 2007 48 | NCT00082407 | Multicenter | Open-label | phase III | 1 | 58.7 | 48.7 | 501 | Exenatide 5 mcg SQ BID for 4 weeks and followed by 10 mcg for 48 weeks (n = 253) | Insulin SC twice daily; titration to target blood glucose level (n = 248) |
LEAD-2 49 | NCT00318461 | Multicenter | Double blind | phase III | 2 | 56.7 | 58.2 | 1087 | Liraglutide 0.6–1.8 mg/day for 104 weeks (n = 724) | Glimepiride 4 mg/day for 104 weeks (n = 242)/ Metformin 1.5–2.0 g/day for 140 weeks (n = 121) |
HARMONY-1 50 | NCT00849056 | Multicenter | Double blind | phase III | 1 | 55 | 59.8 | 301 | Albiglutide 30 mg QW (n = 150) | Placebo (n = 151) |
Seino, 2010 51 | NCT00393718 | Japan | Double blind | phase III | 1 | 58.3 | 67.3 | 400 | Liraglutide 0.9 mg/day for 52 weeks (n = 268) | Glibenclamide 2.5 mg/day for 52 weeks (n = 132) |
AWARD-1 2014 52 | NCT01064687 | Multicenter | Double blind | phase III | 1 | 56.5 | 58.4 | 979 | Dulaglutide 0.75–1.5 mg QW or Exenatide 5 mcg BID for 4 weeks, followed by 10 mcg BID for 48 weeks (n = 837) | Placebo (n = 142) |
HARMONY-4 2014 53 | NCT00838916 | Multicenter | Open-label | phase III | 1 | 55.5 | 56.1 | 745 | Albiglutide 30 mg QW, n = 504 | Insulin, n = 241 |
Seck 2010 54 | NCT00094770 | NR | Double blind | phase III | 2 | 57.3 | 60.1 | 1172 | Sitagliptin 100 mg QD (n = 588) | Glipizide 5 mg QD (n = 584) |
Rosenstock 2013 55 | NCT00121641 | Multicenter | Double blind | phase III | 2 | 53.5 | 50.1 | 401 | Saxagliptin 2.5–10 mg QD (n = 301) | Placebo (n = 95) |
DeFronzo 2009 56 | NCT00121667 | Multicenter | Double blind | phase III | 4 | 54.6 | 50.7 | 743 | Saxagliptin 2.5–10 mg QD (n = 564) | Placebo (n = 179) |
Dobs 2013 57 | NCT00350779 | Multicenter | Double blind | phase III | 1 | 54.6 | 58 | 262 | Sitagliptin 100 mg QD (n = 170) | Placebo (n = 92) |
EUREXA 2012 58 | NCT00359762 | Multicenter | Open-label | phase III | 1 | 56.4 | 53.6 | 1019 | Exenatide 10 mcg BID, n = 511 | Glimepiride 1 mg QD, n = 508 |
Bosi 2011 59 | NCT00432276 | Multicenter | Double blind | phase III | 1 | 55.1 | 51.5 | 803 | Alogliptin 25 mg QD (n = 404) | Placebo (n = 399) |
Corry 2013 60 | NCT00509236 | Multicenter | Double blind | phase III | 1 | 59.5 | 59.7 | 129 | Sitagliptin 25 mg QD (n = 64) | Glipizide 2.5–20 mg QD (n = 65) |
Arjona 2013 61 | NCT00509262 | Multicenter | Double blind | phase III | 1 | 64.6 | 57.1 | 422 | Sitagliptin 25–50 mg QD (n = 210) | Glipizide 2.5–20 mg QD (n = 212) |
Gallwitz 2012 62 | NCT00622284 | Multicenter | Double blind | phase III | 2 | 59.8 | 61 | 1551 | Linagliptin 5 mg QD (n = 776) | Glimepiride 1 mg QD (n = 775) |
Göke 2013 63 | NCT00575588 | Multicenter | Double blind | phase III | 2 | 57.6 | 51.7 | 858 | Saxagliptin 5 mg QD (n = 428) | Glipizide 5–20 mg QD (n = 430) |
Wilson 2013 64 | NCT00707993 | Multicenter | Double blind | phase III | 1 | 69.9 | 44.9 | 441 | Alogliptin 25 mg QD (n = 222) | Glipizide 5–10 mg QD (n = 219) |
AWARD-5 2015 65 | NCT00734474 | Multicenter | Double blind | phase III | 2 | 54 | 46.7 | 921 | Sitagliptin 100 mg QD (n = 315) | Dulaglutide 0.75–1.5 mg QW (n = 606) |
Barnett 2012 66 | NCT00740051 | Multicenter | Double blind | phase III | 1 | 56.6 | 39.9 | 227 | Linagliptin 5 mg QD (n = 151) | Placebo (n = 76) |
Barnett 2013 67 | NCT00757588 | Multicenter | Double blind | phase IIIb | 1 | 57.3 | 57.8 | 455 | Saxagliptin 5 mg QD (n = 304) | Placebo (n = 151) |
TECOS 2015 68 | NCT00790205 | Multicenter | Double blind | phase III | 3 | 65.5 | 70.3 | 14523 | Sitagliptin 100 mg QD (n = 7332) | Placebo (n = 7339) |
HARMONY-3 2014 69 | NCT00838903 | Multicenter | Double blind | phase III | 2 | 54.5 | 47.6 | 1012 | Sitagliptin 100 mg QD (n = 302) | Glimepiride 2 mg QD (n = 307) /Albiglutide 30 mg QW (n = 302) /Placebo (n = 101) |
Del 2014 70 | NCT00856284 | Multicenter | Double blind | phase III | 2 | 55.4 | 49.7 | 2639 | Alogliptin 12.5 mg QD (n = 1765) | Glipizide 5–20 mg QD (n = 874) |
Ferrannini 2013 71 | NCT00881530 | Multicenter | Open- Label | phase II | 1.5 | 58.9 | 44.3 | 388 | Sitagliptin 100 mg QD (n = 56) | Empagliflozin 10–25 mg QD (n = 332) |
Yki-Järvinen 2013 72 | NCT00954447 | Multicenter | Double blind | phase III | 1 | 60 | 52.2 | 1261 | Linagliptin 5 mg (n = 631) | Placebo (n = 630) |
EXAMINE 2013 73 | NCT00968708 | Multicenter | Double blind | phase III | 1.5 | 61 | 67.9 | 5380 | Alogliptin 25 mg QD (n = 2701) | Placebo (n = 2679) |
GENERATION 2015 74 | NCT01006603 | Europe,Mexico | Double blind | phase IIIb/IV | 1 | 72.6 | 61.8 | 720 | Saxagliptin 5 mg QD (n = 360) | Glimepiride 1 mg QD (n = 360) |
Lavalle-González 2013 75 | NCT01106677 | Multicenter | Double blind | phase III | 1 | 55.4 | 46.4 | 1101 | Sitagliptin 100 mg QD (n = 366) | Canagliflozin 100–300 mg QD (n = 735) |
SAVOR-TIMI 53 2013 76 | NCT01107886 | Multicenter | Double blind | phase IV | 2.1 | 65 | 67 | 16492 | Saxagliptin 5 mg QD (n = 8280) | Placebo (n = 8212) |
CANTATA-D2 2013 72 | NCT01137812 | Multicenter | Double blind | phase III | 1 | 56.5 | 55.9 | 755 | Sitagliptin 100 mg QD (n = 378) | Canagliflozin 300 mg QD (n = 378) |
ELIXA 2016 77 | NCT01147250 | Multicenter | Open-label | phase III | 2.1 | 60.3 | 69.4 | 6068 | Lixisenatide 10–20 μg QD, n = 3034 | Non-medication, n = 3034 |
Roden 2015 45 | NCT01289990 | Multicenter | Open-Label | phase III | 1.5 | 55 | 61.3 | 899 | Sitagliptin 100 mg QD (n = 223) | Empagliflozin 10 mg/25 mg QD (n = 448) |
NCT01098539 (139) | Multicenter | Double blind | phase III | 1 | 63.3 | 53.7 | 495 | Albiglutide 30 mg QW (n = 249) | Sitagliptin 100 mg QD (n = 246) | |
NCT01075282(75) | Multicenter | Open-label | phase III | 1.5 | 56.7 | 51.3 | 807 | Dulaglutide 1.5 mg SC QW for 78 weeks, n = 545 | Insulin, n = 262 | |
NCT01648582(49) | Multicenter | Open-label | phase III | 1 | 54.5 | 54.5 | 783 | Dulaglutide 0.75–1.5 mg QW for 52 weeks, n = 526 | Insulin, n = 257 | |
NCT01087502(36) | Multicenter | Double blind | phase III | 1 | 66.6 | 63.4 | 235 | Linagliptin 5 mg (n = 118) | Placebo for 12 weeks and then switch to Glimepiride for further 40 weeks (n = 123) | |
NCT01682759 (108) | Multicenter | Double blind | phase III | 1 | 57.7 | 55.1 | 751 | Omarigliptin 25 mg QW (n = 375) | Glimepiride 1–6 mg QD (n = 376) |