Table 1 Enrollment Criteria

Inclusion criteria:

1) Type 2 diabetes mellitus

2) Age between 40 to 85 years

3) Clinical findings suggestive of arteriosclerosis obliterans (ASO)

Note 1: Definition of ASO: Patient who has the following lesions in either of the lower limbs

   • ABI (ankle brachial pressure index) < 1.0

   • A weakened or bilaterally different pulsation of popliteal artery or dorsal artery of foot

   • clinical signs and symptoms suggestive of ASO

Exclusion criteria:

1) Type 1 diabetes mellitus or secondary diabetes mellitus

2) Age less than 40 or greater than 85 years

3) Severe ASO rated as Fontaine IIb or over

4) Cerebrovascular disorders rated as grade 4 or greater on the Modified Rankin Scale

5) Medical history of angina or myocardial infarction

6) Severe hepatic dysfunction (liver cirrhosis) or renal dysfunction (serum creatinine ≥ 1.5 mg/dL)

7) Congestive heart failure

8) Severe hematological abnormalities

9) Diagnosis of homologous familial hypercholesterolemia

10) Drug allergies or medical history of hypersensitivity to the investigational drugs

11) Pregnant or lactating women, or women who wish to become pregnant

12) Others whom the investigator judges inappropriate as subjects for this study