| EXAMINE | SAVOR-TIMI53 | TECOS | ELIXA | LEADER | SUSTAIN-6 | Overall |
---|---|---|---|---|---|---|---|
Study characteristics | |||||||
 Number of participants | 5380 | 16,492 | 14,671 | 6068 | 9340 | 3297 | 55,248 |
 Location | 898 centers in 49 countries | 788 centers in 26 countries | 673 centers in 38 countries | 782 investigators in 49 countries | 410 sites in 32 countries | 230 sites in 20 countries | – |
 Year of publication (years) | 2013/2015 | 2013 | 2015 | 2015 | 2016 | 2016 | – |
 Length of follow-up (years) | 1.5 | 2.1 | 3.0 | 2.1 | 3.8 | 2.1 | 2.6 |
Study design | Randomized, placebo-controlled | ||||||
 Randomization ratio (incretin: placebo) | 2701:2679 | 8280:8212 | 7332:7339 | 3034:3034 | 4688:4672 | 1648:1649 | 27,683:27,585 |
 Interventions | Alogliptin 6.25/12.5/25 mg versus placebo | Saxagliptin 2.5/5 mg versus placebo | Sitagliptin 50/100 mg versus placebo | Lixisenatide 10–20 μg versus placebo | Liraglutide 0.6–1.8 mg versus placebo | Semaglutide 0.5/1.0 mg versus placebo | – |
Baseline demographic characteristics | |||||||
 Age (years) | 60.9 | 65.0 ± 8.5 | 66.0 ± 8.0 | 60.3 ± 9.7 | 64.3 ± 7.2 | 64.6 ± 7.4 | – |
 Male (%) | 67.9 | 66.9 | 71.0 | 69.3 | 64.3 | 60.7 | 67.6 |
 Race (%) |  |  |  |  |  |  |  |
  White | 72.7 | 75.2 | 67.9 | 75.2 | 77.5 | 83.0 | 73.9 |
  Black | 4.0 | 3.4 | 3.0 | 3.6 | 9.9 | 6.7 | 4.7 |
  Asian | 20.2 | 10.8 | 22.3 | 12.7 | 8.3 | 8.7 | 14.4 |
  Others | 3.0 | 10.6 | 6.8 | 8.5 | 4.3 | 2.2 | 7.0 |
 BMI (kg/m2) | 28.7 ± 11.6 | 31.1 ± 5.6 | 30.2 ± 5.7 | 30.2 ± 5.7 | 32.5 ± 6.3 | 32.8 ± 6.2 | 31.0 ± 5.7 |
 Body weight (kg) | 80.1 ± 25.9 | 87.9 ± 19.1 | NA | 84.9 ± 19.4 | 91.8 ± 21.0 | 92.1 ± 20.6 | NA |
 Duration of diabetes (years) | 7.2 ± 2.8 | 10.3 ± 2.8 | 9.4 ± 2.6 | 9.3 ± 8.3 | 12.7 ± 8.0 | 13.9 ± 8.1 | 9.7 ± 2.7 |
 HbA1c (%) | 8.0 ± 1.1 | 8.0 ± 1.4 | 7.3 ± 0.7 | 7.7 ± 1.3 | 8.7 ± 1.5 | 8.7 ± 1.5 | 7.9 ± 0.3 |
Other medications administrated at baseline (%) | |||||||
 Insulin | 29.8 | 41.4 | 23.2 | 37.8 | 41.8 | 58.0 | 36.1 |
 Metformin | 66.3 | 69.6 | 81.6 | 63.2 | 76.4 | 73.2 | 73.2 |
 Sulfonylureas | 46.5 | 40.2 | 45.3 | 30.7 | 50.5 | 42.8 | 43.0 |
 TZDs | 2.4 | 5.9 | 2.7 | 1.4 | 6.1 | 2.3 | 4.0 |
 ACEI/ARB | 82.0 | 78.5 | 78.8 | 84.9 | NA | 49.8 | NA |
 β-Blocker | 82.0 | 61.4 | 63.5 | 84.4 | 55.4 | 57.4 | 65.3 |
 Aspirin | 90.7 | 75.2 | 71.0 | 94.4 | 69.8 | NA | NA |
 Statin | 90.4 | 78.3 | 79.9 | 92.6 | 72.0 | 72.5 | 80.1 |
Other major risk factors | |||||||
 Hypertension (%) | 83.1 | 81.4 | 86.0 | 76.4 | 90.0 | 92.8 | 84.4 |
 Total cholesterol (mg/dl) | 154.3 ± 43.9 | NA | 165.8 ± 45.3 | 153.0 ± 44.0 | 170.4 ± 45.3 | NA | NA |
 HDL Cholesterol (mg/dl) | 43.2 ± 10.6 | NA | 43.5 ± 12.5 | 43.0 ± 11.0 | 45.5 ± 12.3 | 43.7 ± 27.1 | NA |
 LDL cholesterol (mg/dl) | 78.6 ± 34.7 | NA | 91.0 ± 57.8 | 78.0 ± 35.0 | 89.5 ± 35.5 | 82.3 ± 45.6 | NA |
 Triglycerides (mg/dl) | 164.5 ± 104.0 | NA | 165.4 ± 99.9 | 164.0 ± 113.0 | 182.5 ± 140.0 | NA | NA |
 Current smoker (%) | 13.6 | 13.4 | 11.4 | 11.7 | 12.1 | NA | NA |
Corresponding changes after incretin-based agent intervention | |||||||
 HbA1c (%) | −0.4 | −0.1 | −0.3 | −0.3 | −0.4 | −1.0 or −0.7 for different doses | −0.3 |
 Body weight (kg) | −0.1 | NA | NA | −0.7 | −2.3 | −4.3 or −2.9 for different doses | NA |
 Systolic blood pressure (mmHg) | NA | NA | NA | NA | −1.2 | −2.6 or −1.3 for different doses | NA |
 Diastolic blood pressure (mmHg) | NA | NA | NA | NA | +0.6 | NA | NA |