Table 1.
Items and schedule
| |
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 |
○ |
|
|
|
|
|
|
| Body weight |
○ |
○ |
○ |
○ |
○ |
○ |
○ |
| Blood pressure |
|
○ |
○ |
○ |
○ |
○ |
○ |
| Blood chemistry 1* |
|
○ |
○ |
○ |
○ |
○ |
○ |
| Blood chemistry 2¶ |
|
○ |
|
○ |
|
○ |
○ |
| Urinary albumin excretion |
|
○ |
|
○ |
|
○ |
○ |
| Carotid IMT |
|
○ |
|
○ |
|
○ |
○ |
| baPWV and ABI† |
|
○ |
|
○ |
|
○ |
○ |
| Adherence |
|
|
○ |
○ |
○ |
○ |
○ |
| Adverse events | ○ | ○ | ○ | ○ | ○ | ○ | |
*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.
¶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.
†Including brachial-ankle pulse wave velocity (baPWV) and ankle brachial blood pressure index (ABI).
○Examinations were scheduled.