Status:
COMPLETED
Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects
Lead Sponsor:
Universidade Federal do Rio de Janeiro
Collaborating Sponsors:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Conditions:
Diabetes Mellitus, Type 2
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
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.
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 ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2018
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02242149
Start Date
October 14 2014
End Date
January 31 2018
Last Update
May 3 2018
Active Locations (1)
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1
Program of Arterial Hypertension, University Hospital Clementino Fraga Filho
Rio de Janeiro, Brazil, 21941913