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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