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Table 2 Clinical characteristics of randomized participants in SPIKE

From: Rationale, design, and baseline characteristics of a clinical trial for prevention of atherosclerosis in patients with insulin-treated type 2 diabetes mellitus using DPP-4 inhibitor: the Sitagliptin Preventive study of Intima-media thickness Evaluation (SPIKE)

Parameters

 

Gender (females/males) (%)

109 / 165 (39.8 / 60.2)

Age (years)

63.7 ± 9.8

Current smoking

59 (21.5)

Current alcohol

121 (44.2)

Hypertension

161 (58.8)

Dyslipidemia

174 (63.5)

Duration of diabetes (years)

17.3 ± 8.6

HbA1c (%)

8.0 ± 1.0

Fasting plasma glucose (mg/dl)

154.0 ± 48.9

C-peptide immunoreactivity (ng/ml)

1.2 ± 0.8

Glucagon (pg/ml)

80.5 ± 25.1

Body mass index (kg/m2)

25.0 ± 4.0

Systolic blood pressure (mmHg)

131.1 ± 15.0

Diastolic blood pressure (mmHg)

74.9 ± 11.5

Total-cholesterol (mg/dl)

192.5 ± 34.3

HDL-cholesterol (mg/dl)

55.1 ± 14.5

Triglyceride (mg/dl)

129.3 ± 100.7

LDL-cholesterol (mg/dl)

108.9 ± 28.7

Remnant-like particle lipoprotein (mg/dl)

5.1 ± 6.3

Serum creatinine (mg/dl)

0.7 ± 0.2

urinary albumin excretion (mg/g Cr)

19.3 [8.3-83.7]*

Serum uric acid (mg/dl)

5.3 ± 1.3

Amylase (U/l)

70.0 ± 34.5

Serum ICAM-1(ng/ml)

235.8 ± 90.9

Serum VCAM-1(ng/ml)

833.6 ± 340.3

IL-6 (pg/ml)

1.8 [1.2-2.9]*

hsCRP (mg/dl)

0.050 [0.024-0.116]*

Number of insulin injections

 

   <2/day

100

   >3/day

174

Oral glucose-lowering agents

169 (61.7)

   Metformin

97 (35.4)

   Sulfonylurea

32 (11.7)

   Glinides

21 (7.7)

   Thiazolidinedones

24 (8.8)

   α-glucosidase inhibitor

83 (30.3)

Anti-hypertensive drugs

147 (53.6)

   ACE inhibitors

12 (4.4)

   ARBs

122 (44.5)

   Thiazides

25 (9.1)

   CCB

84 (30.7)

   Others

18 (6.6)

Lipid-lowering agents

145 (52.9)

   Statins

129 (47.1)

   Fibrates

6 (2.2)

   Others

25 (9.1)

Anti-thrombotic agents

61 (22.3)

   Antiplatelets

58 (21.2)

   Anticoagulants

11 (4.0)

  1. Data are number (%) or mean ± SD, or *median [range].
  2. ICAM-1, Intercellular adhesion molecule 1; VCAM-1, Vascular cell adhesion molecule 1; IL-6, Interleukin 6; hs-CRP, High-sensitivity C-reactive protein; ACE, Angiotensin-converting enzyme; ARB, Angiotensin II receptor blocker; CCB, Calcium channel blocker.