NCT02242149

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

October 14, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

September 14, 2014

Last Update Submit

May 2, 2018

Conditions

Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver Disease

Keywords

Fat liverDiabetesDiacereinTransient elastographyTreatment

Outcome Measures

Primary Outcomes (1)

  • Evidence of improvement in glycemic control and improvement in liver steatosis

    Reduction of mean glycated hemoglobin (≥ 1%) and reduction of liver fat fraction as measured by transient elastography (≥ 20%)

    Within 12 and 24 months

Secondary Outcomes (2)

  • Improvement of microalbuminuria

    Within 24 months

  • Changes of adipocytokines and cytokeratin-18

    Within 24 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Diacerein

EXPERIMENTAL

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

Interventions

DiacereinDRUG

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.

Also known as: Artrodar, Artifit, Acert
Diacerein
PlaceboDRUG

Sugar pill manufactured to mimic Diacerein

Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Program of Arterial Hypertension, University Hospital Clementino Fraga Filho

Rio de Janeiro, 21941913, Brazil

Location

Related Publications (1)

  • Cardoso CRL, Leite NC, Carlos FO, Loureiro AA, Viegas BB, Salles GF. Efficacy and Safety of Diacerein in Patients With Inadequately Controlled Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Oct;40(10):1356-1363. doi: 10.2337/dc17-0374. Epub 2017 Aug 17.

    PMID: 28818994DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver DiseaseFatty LiverDiabetes Mellitus

Interventions

diacerein

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLiver DiseasesDigestive System Diseases

Study Officials

  • Gil F Salles, PhD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, Faculty of Medicine

Study Record Dates

First Submitted

September 14, 2014

First Posted

September 16, 2014

Study Start

October 14, 2014

Primary Completion

January 31, 2017

Study Completion

January 31, 2018

Last Updated

May 3, 2018

Record last verified: 2018-05

Locations

BR(1)