Table 1.
Baseline characteristics of participants randomized to diacerein and placebo.
| Characteristics | Diacerein (n = 35) | Placebo (n = 36) | P value |
|---|---|---|---|
| Age (years) | 62 ± 8.0 | 59 ± 11.3 | 0.12 |
| Male | 20 (57.1) | 27 (75.0) | 0.11 |
| Years at school | 6.4 ± 4.1 | 5.6 ± 3.0 | 0.4 |
| Chronic complications of diabetes | 18 (51.4) | 13 (36.1) | 0.19 |
| Cardiovascular disease | 14 (40.0) | 13 (36.1) | 0.7 |
| Hypertension | 29 (82.9) | 31 (86.1) | 0.7 |
| 24 h systolic blood pressure (mmHg) | 120.3 ± 11.5 | 123.1 ± 11.4 | 0.7 |
| 24 h diastolic blood pressure (mmHg) | 75.0 ± 8.4 | 72.3 ± 8.1 | 0.3 |
| Duration of diabetes (years) | 14.0 ± 6.7 | 14.8 ± 6.6 | 0.7 |
| Duration of diabetes 14–30 years | 19 (54.3) | 23 (63.9) | 0.4 |
| Use of oral hypoglycemic agents‡ | |||
| Sulfonylureas | 13 (37.1) | 12 (33.3) | 0.7 |
| Metformin | 25 (71.4) | 31 (86.1) | 0.13 |
| Use of insulin | 17 (48.6) | 22 (61.1) | 0.3 |
| Use of other antidiabetics# | 1 (2.9) | 4 (11.1) | 0.17 |
| Metabolic profile | |||
| HbA1c (%) | 9.1 ± 1.4 | 8.6 ± 1.0 | 0.11 |
| HbA1c (mmol/mol) | 76.7 ± 2.4 | 71.2 ± 2.4 | 0.11 |
| Fasting glucose (mg/dL) | 142.0 ± 69.5 | 138.7 ± 58.2 | 0.8 |
| HOMA-IR | 5.4 ± 1.0 | 6.5 ± 1.0 | 0.4 |
| Lipids | |||
| Total cholesterol (mg/dL) | 149 ± 32.7 | 152.7 ± 34.8 | 0.6 |
| HDLc (mg/dL) | 42.1 ± 7.4 | 42.8 ± 8.0 | 0.7 |
| LDLc (mg/dL) | 73.0 ± 35.6 | 78.5 ± 35.5 | 0.3 |
| Triglycerides (mg/dL) | 200.5 ± 124.4 | 202.4 ± 210.5 | 1.0 |
| Renal | |||
| Creatinine (mg/dL) | 0.93 ± 0.15 | 0.87 ± 0.17 | 0.11 |
| eGFR (mL/min/1.73 m2) | 77.0 ± 13.1 | 83.5 ± 23.5 | 0.13 |
| Urinary albumin/creatinine ratio (mg/24 h) | 9.9 ± 6.6 | 10.8 ± 6.8 | 0.6 |
| Hepatic | |||
| ALT (units/L) | 23.5 ± 11.1 | 23.1 ± 11.3 | 0.9 |
| AST (units/L) | 24.7 ± 11.8 | 21.9 ± 8.1 | 0.2 |
| Gamma-glutamyltransferase (units/L) | 43.4 ± 26.4 | 36.1 ± 20.6 | 0.2 |
| Hematologic/inflammatory | |||
| Hematocrit (%) | 42.0 ± 4.9 | 41.7 ± 4.3 | 0.8 |
| Platelet count (×109 cells/L) | 215.0 ± 55.7 | 221.8 ± 60.0 | 0.6 |
| C-reactive protein (mg/L) | 7.0 ± 6.2 | 9.0 ± 16.4 | 0.5 |
| Anthropometric assessment | |||
| Weight (kg) | 80.3 ± 19.8 | 78.7 ± 13.1 | 0.7 |
| Height (m) | 1.62 ± 0.10 | 1.59 ± 0.07 | 0.16 |
| Body mass index (kg/m2) | 30.8 ± 6.9 | 31.3 ± 5.2 | 0.7 |
Data expressed as mean ± SD and n (%). ‡Numbers exceed 100% due to use of more than one agent. #Alpha-glucosidase inhibitors, meglitinides, DPP4 inhibitors, and amylin mimetics.