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Table 1 Characteristics of participants and study design of six trials

From: Incretin-based agents in type 2 diabetic patients at cardiovascular risk: compare the effect of GLP-1 agonists and DPP-4 inhibitors on cardiovascular and pancreatic outcomes

  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
  1. Data are given as mean (standard deviation) or %, unless otherwise specified
  2. EXAMINE EXamination of cArdiovascular outcomes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome, SAVOR-TIMI53 the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus-Thrombolysis in Myocardial Infarction 53, TECOS Trial Evaluating Cardiovascular Outcomes with Sitagliptin, ELIXA Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome, LEADER Liraglutide Effect and Action in Diabetes: Evaluation of CV Outcome Results, SUSTAIN-6 Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes, BMI body mass index, HbA 1c hemoglobin A1c, TZD thiazolidinedione, ACEI/ARB angiotensin-converting enzyme inhibitors/angiotensin receptor blocker, NA not applicable, HDL high density lipoprotein, LDL low density lipoprotein