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

• Status: Completed
• Trial end date: 2018-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal do Rio de Janeiro
• Collaborator: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Treatments: Diacetylrhein

Criteria

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