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Table 2 Primary and secondary endpoints after 52 weeks (FAS)

From: Comparison of the effects of twice-daily exenatide and insulin on carotid intima-media thickness in type 2 diabetes mellitus patients: a 52-week randomized, open-label, controlled trial

 

Exenatide group (n = 27)

Insulin group (n = 32)

P1 value

Primary endpoint

 Carotid intima-media thickness, adjusted mean change (95% CI) (mm)

− 0.10 (− 0.18, − 0.02)

0.03 (− 0.03, 0.11)

0.016

Secondary endpoints

 Weight (kg)

− 2.21 ± 3.43**

1.57 ± 2.96**

< 0.01

 Systolic pressure (mmHg)

− 1.85 ± 14.35

2.25 ± 18.74

0.357

 Diastolic blood pressure (mmHg)

− 4.25 ± 11.66

− 2.12 ± 10.42

0.461

 HbA1c (%)

− 1.31 ± 1.42**

− 1.09 ± 1.42**

0.561

 Fasting blood glucose (mmol/L)

− 0.79 ± 3.49

− 2.39 ± 3.40**

0.085

 Total cholesterol (mmol/L)

− 0.29 ± 1.20

− 0.05 ± 1.04

0.433

 Triglyceride (mmol/L)

− 0.17 ± 1.49

− 0.08 ± 1.55

0.826

 Low density lipoprotein (mmol/L)

− 0.36 ± 0.83*

− 0.15 ± 0.87

0.365

 High density lipoprotein (mmol/L)

0.02 ± 0.16

− 0.00 ± 0.15

0.416

 High sensitivity C-reactive protein (mg/L)

0.39 ± 2.55

1.66 ± 4.55*

0.183

 Fibrinogen (g/L)

0.35 ± 0.44**

0.48 ± 0.48**

0.290

 8-OHdG, ng/dL (ng/mL)

− 2.45 ± 0.74**

− 2.00 ± 0.75**

0.058

Exploratory endpoints

 Irisin (pg/mL)

26.01 ± 7.86**

24.91 ± 8.65**

0.665

 Brain natriuretic peptide (pg/mL)

− 103.55 ± 39.47**

− 84.11 ± 27.95**

0.065

  1. Data are presented as mean change ± standard deviation unless otherwise noted
  2. 8-OHdG 8-hydroxydeoxyguanosine
  3. ** and * were represented as significantly different from baseline with P < 0.01 and P < 0.05, respectively
  4. 1P value is shown for mean change comparison between exenatide and insulin group