Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects (DGCLFT2DM)

May 2, 2018 updated by: Gil Fernando da Costa Mendes de Salles, PhD, Universidade Federal do Rio de Janeiro
This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults treatment with diacerein will improve glycemic control and will reduce liver fat within a 24 month period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Recently, knowledge about diacerhein, an anthraquinone drug with powerful anti-inflammatory properties, revealed that this drug improves insulin sensitivity, mediated by the reversal of chronic subclinical inflammation. Amongst the numerous pathogenetic factors, oxidative stress and apoptosis of hepatocytes initiate many inflammatory processes and are involved in the progression of Non alcoholic fatty liver disease.

Aims:The aim is to evaluate the effect of treatment with diacerein in improvement of glycemic parameters (mean glycated hemoglobin, fasting blood sugar) and reduction of liver fat fraction.

Methods:Two-hundred patients will be randomly allocated either to treatment with diacerein plus their usual therapeutic regimen or to placebo for 24 months. Clinic, laboratory evaluation (including glycated hemoglobin, fasting blood sugar, creatinine, ferritin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), g-glutamyl transpeptidase, alkaline phosphatase, bilirubin, albumin, prothrombin time, platelet count, total cholesterol, high-density and low-density lipoprotein cholesterol and triglycerides and urinary albumin excretion rate no 24-hour urine collection) will be performed before and every 3 months until the end of study. Pro-Inflammatory cytokines, adiponectin and cytokeratin-18 were measured before, at 12 months and at the end of study. Liver fat fraction measurement using controlled attenuation parameter (CAP) by transient elastography. (Fibroscan) will be performed before and after the 12 and 24-month treatment, with the observers blinded to the allocation group.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

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

  • Brazil
      • Rio de Janeiro, Brazil, 21941913
        • Program of Arterial Hypertension, University Hospital Clementino Fraga Filho

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

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes.
  • Presence of liver steatosis diagnosed by ultrasound or transient elastography (Fibroscan®)
  • Age 30-75 years.
  • HbA1c 7.5- 9.5 for at least 8 weeks prior to screening.
  • Stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents with or without insulin for 8 weeks prior to randomization.

Exclusion Criteria:

  • Body mass index > 40 kg/m2
  • Serum creatinine ≥180mmol/L or estimated glomerular filtration rate < 30 ml/min.
  • Presence of any serious concomitant disease, such as a pulmonary disease or malignant disorders.
  • Current daily alcohol ingestion ≥20 g.
  • Hepatotoxic drugs.
  • Presence of other chronic liver disease other than nonalcoholic fatty liver disease, including hepatitis B virus and hepatitis C virus infection, hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, autoimmune hepatitis.
  • Women seeking pregnancy.
  • Current use or previous use within 6 months of vitamin E or pioglitazone

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
All subjects will be given placebo identically matched with regard to shape, color and taste. They will be given one tablet/day for 2 weeks and then two tablets/day for the duration of sudy.
Drug: Placebo
Sugar pill manufactured to mimic Diacerein
Experimental: Diacerein
All subjects will be given diacerein with a starting dose of 50 mg in one tablet once daily for 2 weeks. After 2 weeks, they will be given diacerein 50 mg in one tablet twice daily for the duration of sudy.
Drug: Diacerein
All subjects will be given diacerein with a starting dose of 50 mg in one tablet once daily for 2 weeks. After 2 weeks, they will be given diacerein 50 mg in one tablet twice daily for the duration of sudy.
Other Names:
  • Artrodar
  • Artifit
  • Acert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of improvement in glycemic control and improvement in liver steatosis
Time Frame: Within 12 and 24 months
Reduction of mean glycated hemoglobin (≥ 1%) and reduction of liver fat fraction as measured by transient elastography (≥ 20%)
Within 12 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of microalbuminuria
Time Frame: Within 24 months
Reduction of albumin excretion rate on 24-hour urine collection
Within 24 months
Changes of adipocytokines and cytokeratin-18
Time Frame: Within 24 months
Elevation of high molecular weight adiponectin and reduction of the apoptotic by-product cytokeratin (CK)-18
Within 24 months

Collaborators and Investigators

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

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators

  • Principal Investigator: Gil F Salles, PhD, Universidade Federal do Rio de Janeiro

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 (Actual)

October 14, 2014

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

September 14, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30194914.3.0000.5257

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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