Effect of diacerein in patients with diabetes treated with antihyperglycemic drugs

Phase 3

• Conditions: E10-E14; Diabete Melito

• Registration Number: RBR-29j956
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

35 years old and older; HbA1c > 7.5%; type 2 Diabete mellitus withou microalbuminuria and/or nephropaty; Using oral antihiperglicemic drugs(sulfonilureias and or metformin)

Exclusion Criteria

Pregnant and lactating women; Chronic inflammatory diseases such as rheumatoid arthritis, osteoarthritis; Use of anti-inflammatory drugs for more than 5 days in the last 3 months; Previous diagnosis of pancreatitis; Hypersensitivity to Reina (active metabolite of diacerein) and other antraquinonic derivatives (laxative); Diabetic Nephropathy and \ or kidney failure; Liver disease (transaminases> 2.5 times the upper limit of normality); Severe gastrointestinal disease; Persistent diarrhea (> 3 stools in 24 hours); Signs of intercurrent infection; Participation in another clinical study in past 30 days; Failure to follow the research protocol; using pioglitazone;

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The outcome is the delta of plasma concentration of glycated hemoglobin ( final value - baseline value, in %), measured by immunoturbidimetric assay in plasma samples.<br> <br>The between groups expected difference is 1.1%.<br><br><br><br><br><br><br><br><br><br><br><br><br>

Secondary Outcome Measures

Name	Time	Method
Delta of fasting glucose (mg/dL); enzymatic and colorimetric method.<br>Levels of acute phase inflammatory markers: C-reactive protein, interleukin-1, interleukin-6, TNF-alpha (Luminex® Human Ultrasensitive ). <br>Delta lipid profile: <br>plasma concentration of total cholesterol, LDL, HDL, triglycerides. <br>Adverse events rate.