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Table 1 Items and schedule

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)

 

Registration

Treatment period (weeks)

 

visit 1 (-4 to 0 wks)

Visit 2 (0)

Visit 3 (26)

Visit 4 (52)

Visit 5 (78)

Visit 6 (104)

At discontinuation

Patient characteristics

â—‹

      

Body weight

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

Blood pressure

 

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

Blood chemistry 1*

 

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

Blood chemistry 2¶

 

â—‹

 

â—‹

 

â—‹

â—‹

Urinary albumin excretion

 

â—‹

 

â—‹

 

â—‹

â—‹

Carotid IMT

 

â—‹

 

â—‹

 

â—‹

â—‹

baPWV and ABI†

 

â—‹

 

â—‹

 

â—‹

â—‹

Adherence

  

â—‹

â—‹

â—‹

â—‹

â—‹

Adverse events

 

â—‹

â—‹

â—‹

â—‹

â—‹

â—‹

  1. *Including aspirate aminotransferase, alanine aminotransferase, γ-glutamyl transpeptidase, creatinine, uric acid, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, fasting plasma glucose, HbA1c and amylase.
  2. ¶Including C-peptide immunoreactivity, glucagon, serum intercellular adhesion molecule 1 (ICAM-1), vascular cell adhesion molecule 1 (VCAM-1), interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), remnant-like particle lipoprotein, 8-hydroxydeoxyguanosine (8-OHDG), thiobarbituric acid reactive substances (TBARS) and adiponectin.
  3. †Including brachial-ankle pulse wave velocity (baPWV) and ankle brachial blood pressure index (ABI).
  4. â—‹Examinations were scheduled.