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

March 15, 2011 updated by: Sun Yat-sen University

Effect of Intravenous and Oral Therapy With Sulodexide on Albuminuria in Type 2 Diabetic Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • endocrinology department of the first affiliated hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sequencial use of sulodexide
Patients will be given sulodexide 1200 LSU per day intravenously for 2 weeks. Then patients will receive 1000 LSU per day orally for 50 weeks.
Drug: intravenous use of sulodexide followed by oral use
Patients will be given sulodexide 1200 LSU per day intravenously for 2 weeks,then receive 1000 LSU per day orally for 50 weeks.
Other Names:
  • sequential use of sulodexide
Active Comparator: oral use of sulodexide
Patients allocated to oral group will received 1000 LSU per day orally for 52 weeks
Drug: use of sulodexide orally only
Patients receive 1000 LSU per day orally for 52 weeks
Other Names:
  • oral use of sulodexide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in urine albumin/creatinine ratio
Time Frame: 52th week since the commence of therapy
conversion to normoalbuminuria and at least a 25% reduction in UACR opposed to baseline, or 50% reduction in UACR opposed to baseline
52th week since the commence of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in urine albumin/creatinine ratio and serum creatinine
Time Frame: before and 2nd,12th,24th,36th and 60th week since the commence of therapy
before and 2nd,12th,24th,36th and 60th week since the commence of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

ALFA WASSERMANN（BJ) Market Research and Management Co., Ltd

Investigators

  • Principal Investigator: Yanbing Li, PhD, First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

August 1, 2012

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (Estimate)

March 16, 2011

Study Record Updates

Last Update Posted (Estimate)

March 16, 2011

Last Update Submitted That Met QC Criteria

March 15, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sulodexide20110311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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