Table 1.
Baseline characteristics of patients in placebo-controlled trial.
| Parameters | Placebo (n = 21) |
Amlexanox (n = 21) |
p-value | |
|---|---|---|---|---|
| Demographics | Gender (Female/Male) | 10/11 | 10/11 | STRATIFIED |
| Age | 59±8 | 56±8 | 0.21 | |
| Race: Caucasian, African, Asian American | 19, 2, 0 | 19, 1, 1 | 0.51 | |
| History of tobacco use | 8 | 12 | 0.35 | |
| Baseline Medications | Antidiabetics: Metformin, Sulfonylurea, DPP4 inhibitor, TZD, SGLT2 inhibitor, Repaglinide | 19, 9, 4, 0, 0, 0 | 17, 4, 3, 2, 1, 1 | 0.41, 0.18, 1.00, 0.49, 1.00, 1.00 |
| Anti-hypertensives: ACE inhibitor, ARB, CCB, β-blocker, Diuretic, Other | 10, 5, 2, 4, 10, 1 | 11, 3, 4, 4, 7, 1 | 1.00, 0.70, 0.66, 1.00, 0.53, 1.00 | |
| Other: Statins, Aspirin, NSAID, Antidepressants, Thyroid hormone | 12, 6, 4. 7, 3 | 18, 10, 2, 6, 4 | 0.09, 0.34, 0.66 1.00, 1.00 | |
| Medical History | Diabetes history (years) | 9±6 | 8±5 | 0.56 |
| Diabetic Retinopathy, Diabetic Neuropathy | 0, 5 | 3,9 | 0.23, 0.33 | |
| Hyperlipidemia, Hypertension, Heart disease/attack, Stroke | 16, 15, 2, 3 | 19, 14, 3, 1 | 0.41, 1.00, 1.00, 0.61 | |
| Thyroid disease, Kidney disease History of cancer, Arthritis | 3, 4, 5, 14 | 5, 1, 2, 9 | 0.70, 0.34, 0.41, 0.21 | |
| Asthma/Emphysema, Sleep Apnea | 3, 6 | 6, 9 | 0.45, 0.52 | |
| Polycystic-ovarian syndrome | 2 | 1 | 1.00 | |
| Psychiatric diagnosis (depression or anxiety) | 8 | 7 | 1.00 | |
| ROS: Muscle weakness, Loss of Sensation, Tingling hands/feet | 0, 3, 6 | 2, 6, 7 | 0.49, 0.45 1.00 | |
| Physical exam | Weight (kg) | 98±20 | 100±15 | 0.90 |
| Height (cm) | 171±12 | 172±8 | 0.71 | |
| Body mass index (kg/m2) | 33.5±4.6 | 33.9±4.3 | 0.94 | |
| Systolic blood pressure (mm, Hg) | 132±16 | 131±14 | 0.94 | |
| Diastolic blood pressure (mm,Hg) | 76±9 | 75±7 | 0.73 | |
| Pulse | 69±9 | 72±11 | 0.35 | |
| Acanthosis nigricans, Arrhythmias, Murmurs | 4, 1, 1 | 2, 2, 2 | 0.66, 1.00, 1.00 | |
| Liver enlarged, Total Liver span (cm) | 14, 10±2 | 13, 10±2 | 1.00, 0.98 | |
| Biochemical parameters | HbA1c (%) | 7.6±0.8 | 7.7±1.0 | 0.76 |
| Fructosamine (µmol/L) | 281±58 | 278±52 | 0.89 | |
| Fasting glucose (mg/dL) | 165±51 | 151±39 | 0.32 | |
| Fasting insulin (µU/mL) | 22.4±14.2 | 20.1±12.6 | 0.58 | |
| HOMA-IR | 8.48±4.82 | 7.67±6.68 | 0.65 | |
| Triglycerides (mg/dL) | 181±122 | 171±81 | 0.76 | |
| Cholesterol (mg/dL) | 159±35 | 161±32 | 0.84 | |
| HDL (mg/dL) | 42±14 | 42±7 | 1.00 | |
| LDL (mg/dL) | 83±28 | 85±29 | 0.88 | |
| WBC count (K/µl) | 7.0±1.5 | 6.9±1.5 | 0.94 | |
| Hemoglobin (d/dL) | 13.2±1.6 | 13.9±1.1 | 0.11 | |
| Platelets (K/µl) | 241±119 | 219±32 | 0.42 | |
| Creatinine kinase (IU/L) | 124±75 | 178±167 | 0.19 | |
| ALT | 38±18 | 37±17 | 0.82 | |
| CRP (µg/mL) | 2.35±1.88 | 2.90±2.04 | 0.40 | |
| 24 Hour urine protein, quantity (g/24 hr)a | 0.09±0.11 | 0.18±0.40 | 0.42 | |
| % Fat | DEXA Total | 41.13±6.38 | 39.94±7.69 | 0.59 |
| DEXA Trunk | 46.97±4.87 | 45.06±6.13 | 0.27 | |
| MRI Quantitativeb | 12.8±7.8 | 18.0±9.7 | 0.20 | |
Data represent either n per group or mean ± SD.
a
n = 16 in each group, based on patient returned samples
b
n = 9 in Placebo, and 11 in Amlexanox group
DPP4: Dipeptidyl peptidase-4, TZD: Thiazolidinediones, SGLT2: Sodium-Glucose Transporter 2, ACE: Angiotensin converting enzyme, ARB: Angiotensin receptor blocker, CCB: Calcium channel blocker, NSAID: Non-steroidal anti-inflammatory agents, ROS: Review of Systems