Table 1.
Baseline Characteristics by Random Treatment Assignment
| Insulin Sensitization | Insulin Provision | P Value | |
|---|---|---|---|
| n | 1159 | 1160 | |
| Demographics | |||
| Female, n (%) | 349 (30.1) | 346 (29.8) | .92 |
| Age (mean ± SD) | 61.8 (9.1) | 61.9 (8.6) | .82 |
| Non-US patient, n (%) | 435 (37.5) | 427 (36.8) | .75 |
| Medical Insurance (%) | .87 | ||
| Medicare | 301 (26.1) | 293 (25.3) | |
| Other public | 504 (43.6) | 503 (43.5) | |
| Private | 298 (25.8) | 313 (27.1) | |
| None/self-pay | 52 (4.5) | 47 (4.1) | |
| Medical history | |||
| Duration of diabetes in years (median [IQR]) | 8.3 [3.8–14.8] | 9.1 [3.7–15.7] | .15 |
| History of CHF, n (%) | 72 (6.3) | 72 (6.2) | 1.00 |
| History of hypercholesterolemia, n (%) | 924 (80.8) | 950 (83.0) | .19 |
| History of stroke/TIA, n (%) | 114 (9.9) | 111 (9.6) | .85 |
| History of hypertension, n (%) | 929 (81.1) | 960 (83.8) | .09 |
| History of hypoglycemia, n (%) | 229 (20.0) | 270 (23.6) | .04 |
| History of MI, n (%) | 374 (32.8) | 361 (31.6) | .55 |
| Prior coronary revascularization, n (%) | 265 (22.9) | 279 (24.1) | .53 |
| Physical exam | |||
| Serum creatinine mg/dL (mean (±SD)) | 1.0 (0.3) | 1.1 (0.3) | .47 |
| Sitting diastolic BP, mm Hg (mean (±SD)) | 74.6 (11.4) | 74.6 (11.1) | .98 |
| Sitting systolic blood pressure, mm Hg (mean (±SD)) | 131.7 (19.8) | 131.9 (20.3) | .88 |
| ABI <0.90, n (%) | 213 (20.5) | 226 (21.5) | .63 |
| Sitting 60-sec pulse (mean (±SD)) | 68.5 (10.7) | 67.9 (10.5) | .12 |
| BMI, kg/m2 (median [IQR]) | 30.9 [27.6–34.7] | 30.9 [27.6–34.8] | .94 |
| Lifestyle | |||
| Level of activity, n (%) | .55 | ||
| Sedentary | 258 (22.4) | 251 (21.8) | |
| Mild | 488 (42.3) | 468 (40.7) | |
| Moderate/strenuous | 407 (35.3) | 431 (37.5) | |
| Cigarette Smoking Category, n (%) | .12 | ||
| Never smoked | 403 (34.8) | 363 (31.4) | |
| Former smoker | 607 (52.4) | 654 (56.6) | |
| Current smoker | 148 (12.8) | 138 (11.9) | |
| Core Lab Measures from the Biochemistry Laboratories | |||
| HDL, mg/dL (mean (±SD)) | 37.9 (10.0) | 38.5 (10.6) | .22 |
| LDL mg/dL (mean (±SD)) | 95.6 (33.9) | 96.92 (33.0) | .35 |
| Total cholesterol, mg/dL (median [IQR]) | 163 [140–190] | 167 [144–193] | .08 |
| Triglycerides cholesterol, mg/dL (median [IQR]) | 147 [101–221] | 149 [108–219] | .34 |
| HbA1c % (median [IQR]) | 7.3 [6.4–8.6] | 7.3 [6.5–8.5] | .51 |
| Core lab measures from the ECG Core Laboratory | |||
| Presence of abnormal Q-waves, n (%) | 227 (20.2) | 195 (17.3) | .10 |
| Abnormal ST depression, n (%) | 179 (17.0) | 180 (17.1) | .98 |
| Abnormal T-waves, n (%) | 448 (42.5) | 446 (42.4) | 1.00 |
| Abnormal LVEF, n (%) | 203 (18.1) | 182 (16.2) | .26 |
| Medications | |||
| Insulin, n (%) | 316 (27.3) | 329 (28.4) | .58 |
| Biguanide, n (%) | 634 (54.8) | 620 (53.5) | .56 |
| Thiazolidinedione, n (%) | 224 (19.4) | 213 (18.4) | .58 |
| Sulfonylurea, n (%) | 625 (54.0) | 611 (52.7) | .56 |
| Statin, n (%) | 866 (74.9) | 861 (74.4) | .82 |
| Beta-blocker, n (%) | 860 (74.4) | 825 (71.3) | .10 |
| Calcium channel blockers, n (%) | 346 (29.9) | 383 (33.1) | .11 |
| Nonsublingual nitrate, n (%) | 369 (32.0) | 357 (30.8) | .58 |
| ACE inhibitor, n (%) | 738 (63.8) | 755 (65.3) | .49 |
| Angiotensin receptor blocker, n (%) | 172 (14.9) | 163 (14.1) | .63 |
| Aspirin, n (%) | 1022 (88.6) | 1016 (87.9) | .62 |
| Antiplatelet therapy (nonaspirin), n (%) | 232 (20.1) | 219 (18.9) | .52 |
| Diuretic, n (%) | 440 (38.0) | 450 (38.9) | .70 |
ABI = ankle-brachial index; ACE = angiotensin-converting enzyme; BMI = body mass index; CHF = congestive heart failure; ECG = electrocardiogram; HbA1c = glycohemoglobin; HDL = high-density lipoprotein; IQR = interquartile range; LDL = low-density lipoprotein; LVEF = left ventricular ejection fraction; MI = myocardial infarction; SD = standard deviation; TIA = transient ischemic attack.