Clinical trial NCT01316068: Effect of Sulodexide on Albuminuria in Chinese Type 2 Diabetic Patients
Official title: Effect of Intravenous and Oral Therapy With Sulodexide on Albuminuria in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Nephropathy
Albuminuria
Keywords: diabetic nephropathy
albuminuria
type 2 diabetes
sulodexide
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: ALFA WASSERMANN（BJ) Market Research and Management Co., Ltd
First posted: 2011-03-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current therapies targeting albuminuria in diabetic nephropathy leave residual urinary albumin secretion, which meanwhile leave residual cardiovascular risk. Previous studies demonstrated that sulodexide could reduce albuminuria in type 2 diabetic patients. But no data concerning Chinese population is available. The investigators aim to provide evidence of effects of sulodexide on diabetic nephropathy in Chinese diabetic patients. Further the investigators also test the hypothesis that sequential administration of intravenous and oral replacement of the drug would gain an earlier and greater reduction of albuminuria, compared with oral use only.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in urine albumin/creatinine ratio
timeFrame: 52th week since the commence of therapy
Secondary outcomes:
measure: Change from Baseline in urine albumin/creatinine ratio and serum creatinine
timeFrame: before and 2nd,12th,24th,36th and 60th week since the commence of therapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: endocrinology department of the first affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Yanbing Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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