Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients (Soften)

Inclusion Criteria:

• Diagnosis of type 2 diabetes based on WHO criteria
• Age 18-75 years old
• Serum creatinine ≤ 1.5 mg/dL (130umol/L)
• Albuminuria defined by a urine albumin/creatinine ratio(ACR) according to ADA criteria 2009 (microalbuminuria by 30-299 ug albumin/mg creatinine and macroalbuminuria by ≥300 ug albumin/mg creatinine on random spot urine collection )
• Continued stable seated systolic blood pressure < 180 mmHg and diastolic blood pressure < 110 mmHg
• Willing to change antihypertensive medication regimen if necessary
• Willing to provide written informed consent to participate in the study
• Willing to take contraception,or infertility for the duration of the study

Exclusion Criteria:

• Type 1 diabetes mellitus
• Present acute diabetic complication, or severe chronic diabetic complication(e.g. proliferative diabetic retinopathy)
• Complicating uncontrolled severe infection
• Hepatic insufficiency or renal insufficiency or severe disturbance of lipid metabolism
• Blood pressure ≥ 180/110mmHg
• Severe concomitant systemic disease(e.g. cardiac insufficiency, stroke), anticipated to be unable to finish the trial
• Uncooperative,unable to follow up, or anticipated unable to finish the trial
• Patients with other known specific renal diseases
• Untreated urinary tract infection that would impact urinary protein values
• Evidence of hepatic dysfunction including total bilirubin > 2.0 mg/dL (34 mmol/L) or elevated transaminases
• History of Cardiovascular disease as follows: Unstable angina pectoris, myocardial infarction, transient ischemic attack, cerebrovascular accident, New York Heart Association Functional Class III or IV heart failure, obstructive valvular heart disease or hypertrophic cardiomyopathy
• Any risk of bleeding, or platelet count < 100×109/L or anticipated surgery within research period
• Active, recurrent or metastatic cancer, or known HIV infection
• Participant in any experimental drug study in the past 90 days prior to the enrollment of the study, or plan to participate in any drug study during the study period
• Prior exposure to sulodexide, either in a clinical setting or as a participant in another clinical study
• Known allergy or intolerance to any heparin-like compounds or multiple drug allergies
• Lactation, pregnancy, or an anticipated or planned pregnancy during the study period
• Inability to give an informed consent or to cooperate with researchers (e.g. psychiatric disorder) or history of noncompliance to medical regimen