Effect of Diacerein on Metabolic Control and Inflammatory Markers in Patients with Type 2 Diabetes Using Antidiabetic Agents: A Randomized Controlled Trial

Abstract

Introduction Studies have shown that T2DM is an inflammatory disease. Thus, the present study was aimed at evaluating whether diacerein could improve the metabolic and inflammatory profile among patients with T2DM under long-term treatment with glucose-lowering agents. Methods This is a double-blind, parallel, placebo-controlled trial with 72 participants randomly assigned to diacerein 50 mg or placebo for 12 weeks. The primary endpoint was the between-group difference in change in HbA1c. Secondary endpoints included the proportion of patients achieving metabolic control [HbA1c ≤ 7.0% (53 mmol/mol)] and change in inflammatory mediators. Results Participants in the diacerein group had greater reductions in mean HbA1c level in comparison to placebo (−0.98; 95% CI: −2.02 to 0.05, P = 0.06), independently of confounding factors. The difference in HbA1c level was −1.3 (95% CI: −2.3 to −0.4) in favor of diacerein (P = 0.007) in those with <14 years of diabetes duration versus 0.05 (−0.7 to 0.8; P = 0.9) in those with longer duration. The diacerein group had a 50% increase in the number of participants at the lowest TNF-α level (≤1.46 pg/mL). Conclusions In patients with long-established T2DM under long-term treatment with glucose-lowering agents, diacerein improves metabolic control as measured by HbA1c level and has a favorable impact on inflammatory profile. Clinical Trial Registry This trial is registered with Brazilian Clinical Trials Registry (ReBEC) number RBR-29j956.

The Effect of Diacerein on Type 2 Diabetic Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials with Trial Sequential Analysis

“…One was excluded because of duplication [16] while one was ruled out because of insufficient data [35] ( Figure 1). Finally, five RCTs were included [15][16][17][18]36].…”

“…A total of 278 patients were included. A 100 mg dose was used in 3 RCTs [16,18,36]. Gradient dosages (50 mg and 100 mg) were used in 2 RCTs [15,17].…”

“…Patients had received angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers for at least 3 months in one RCT [18]. Therapy regimen was not detailed in the other three RCTs [16,17,36]. Basic characteristics of the five RCTs are summarized in Table 1.…”

“…All five studies reported the improvement of fasting blood glucose [15][16][17][18]36]. Compared with patients in the control group, diacerein provided improvement of FBG (MD -0.52; 95% CI (-0.89~-0.14); P = 0:007) with insignificant heterogeneity (I 2 = 22%, P = 0:28) ( Figure 3).…”

Antidiabetic potential of anthraquinones: A review

“…Diacerein (100 mg/day) consumption for 48 weeks reduced mean glycated hemoglobin levels (0.35%) and hyperlipidemia but did not show significant FBG reduction in Type 2 diabetes subjects (Cardoso et al, ). In a randomized controlled trial, diacerein (50 mg/day) ingestion for 12 weeks was shown to reduce FGB (2.7%), ameliorate insulin resistance, and hyperlipidemia in the human subjects (Tres et al, ).…”