Table 2.
Mean values during the 12-week treatment and adjusted differences in mean changes between diacerein and placebo for the trial outcomes (mean ± SE).
| Diacerein (n = 35) | Placebo (n = 36) | Adjusted difference in mean change (diacerein-placebo)∗ | P value | |||
|---|---|---|---|---|---|---|
| End of trial | Change from baseline | End of trial | Change from baseline | |||
| Metabolic profile | ||||||
| HbA1c (%) | 8.1 ± 0.2 | −0.98 ± 0.2 | 8.1 ± 0.2 | −0.52 ± 0.2 | −0.98 (−2.02 to 0.05) | 0.06 |
| HbA1c (mmol/mol) | 65.9 ± 2.6 | −10.8 ± 2.4 | 65.5 ± 2.6 | −5.7 ± 2.3 | −10.8 (−22.0 to 0.5) | 0.06 |
| Fasting glucose (mg/dL) | 146.3 ± 13.1 | 4.3 ± 11.9 | 150.4 ± 12.9 | 11.8 ± 11.8 | −19.8 (−78.3 to 38.5) | 0.5 |
| HOMA-IR | 5.3 ± 0.8 | −0.18 ± 0.7 | 6.2 ± 0.8 | −0.27 ± 0.7 | 1.0 (−2.6 to 4.6) | 0.6 |
| Lipids | ||||||
| Total cholesterol (mg/dL) | 148.7 ± 5.5 | −0.3 ± 4.6 | 151.1 ± 5.2 | −1.6 ± 4.5 | −0.12 (−22.9 to 22.6) | 1.0 |
| HDLc (mg/dL) | 41.3 ± 1.3 | −0.8 ± 0.9 | 42.8 ± 6.9 | −0.03 ± 0.8 | −2.2 (−6.4 to 2.1) | 0.3 |
| LDLc (mg/dL) | 79.9 ± 5.1 | 6.8 ± 6.1 | 78.2 ± 5.0 | −3.2 ± 6.0 | 20.1 (−10.4 to 50.5) | 0.19 |
| Triglycerides (mg/dL) | 153.1 ± 17.7 | −47.4 ± 23.2 | 164.7 ± 17.4 | −37.7 ± 22.9 | −78.7 (−193.4 to 36.1) | 0.18 |
| Renal | ||||||
| Creatinine (mg/dL) | 1.0 ± 0.04 | 0.06 ± 0.03 | 1.0 ± 0.04 | 0.03 ± 0.03 | 0.12 (−0.03 to 0.26) | 0.11 |
| eGFR (mL/min/1.73 m2) | 73.9 ± 3.2 | −3.1 ± 1.9 | 81.7 ± 3.2 | −1.8 ± 1.9 | −7.7 (−17.3 to 1.9) | 0.12 |
| Urinary albumin/creatinine ratio (mg/24 h) | 24.0 ± 5.6 | 14.1 ± 5.2 | 27.3 ± 5.5 | 16.5 ± 5.2 | 6.0 (−19.4 to 31.4) | 0.6 |
| Hepatic | ||||||
| ALT (units/L) | 24.4 ± 2.4 | 0.9 ± 1.6 | 25.1 ± 2.4 | 2.0 ± 1.5 | 0.5 (−6.5 to 7.5) | 0.8 |
| AST (units/L) | 27.1 ± 2.3 | 2.4 ± 1.5 | 26.2 ± 2.3 | 4.3 ± 1.5 | −0.6 (−8.0 to 6.8) | 0.9 |
| Gamma-glutamyltransferase (units/L) | 44.9 ± 4.9 | 1.5 ± 2.4 | 39.3 ± 4.8 | 3.2 ± 2.3 | −7.7 (−19.3 to 4.0) | 0.19 |
| Hematologic/inflammatory | ||||||
| Hematocrit (%) | 42.7 ± 0.8 | 0.8 ± 0.8 | 43.4 ± 0.8 | 1.7 ± 0.8 | 0.5 (−3.6 to 4.5) | 0.8 |
| Platelet count (×109 cells/L) | 230 ± 10.2 | 15.03 ± 7.3 | 236 ± 10.0 | 14.6 ± 7.2 | −5.1 (−41.6 to 31.4) | 0.8 |
| C-reactive protein (mg/L) | 9.0 ± 2.5 | 2.0 ± 3.3 | 12.3 ± 2.5 | 3.3 ± 3.2 | −9.8 (−25.3 to 5.7) | 0.2 |
| Anthropometric assessment | ||||||
| Weight (kg) | 77.6 ± 2.6 | −2.7 ± 0.7 | 77.3 ± 2.6 | −1.4 ± 0.7 | −2.4 (−5.6 to 0.9) | 0.16 |
| Body mass index (kg/m2) | 29.8 ± 1.0 | −1.0 ± 0.2 | 30.8 ± 1.0 | −0.6 ± 0.2 | −0.8 (−2.0 to 0.4) | 0.19 |
∗Mean adjusted for age, gender, duration of diabetes, and addition of new antidiabetic drugs.