Table 1 Baseline patient demographics and clinical characteristics (treated set)
Values are mean (±SD) or % of subjects | Linagliptin 5 mg (n = 366) | Placebo (n = 146) |
|---|---|---|
Age, years | 59.8 (10.2) | 58.8 (9.8) |
Male, % | 50.0 | 58.2 |
Race, % | Â | Â |
  American Indian/Alaska Native | 0.5 | 0.7 |
  Asian | 36.3 | 34.9 |
  Black/African American | 1.6 | 1.4 |
  White | 61.5 | 63.0 |
HbA1c, % | 8.3 (0.9) | 8.4 (0.9) |
FPG, mg/dl* | 176 (52) | 178 (39) |
BMI, kg/m2 | 29.9 (5.1) | 29.9 (4.9) |
eGFR, % | Â | Â |
  ≥ 90 ml/min | 50.5 | 54.8 |
  60 to < 90 ml/min | 41.5 | 38.4 |
  30 to < 60 ml/min | 7.9 | 6.8 |
Urine albumin-to-creatinine ratio, mg/g, median (range)†| 60 (30–292) | 64 (30–298) |
SBP, mm Hg | 138 (15) | 135 (16) |
DBP, mm Hg | 81 (10) | 81 (10) |
Metabolic syndrome, % | 64.8 | 60.3 |
Time since diagnosis of diabetes, % | Â | Â |
  Up to 1 year | 11.2 | 13.7 |
  > 1 to 5 years | 29.5 | 32.9 |
  > 5 years | 59.3 | 53.4 |
Number of prior antidiabetes drugs, % | Â | Â |
  0 | 13.7 | 24.0 |
  1 | 35.5 | 31.5 |
  2 | 50.3 | 44.5 |
  3 | 0.5 | 0.0 |
Antihypertensive therapy, % | 86.3 | 84.9 |
  Beta-blockers | 29.8 | 23.3 |
  ACE inhibitors | 40.4 | 41.1 |
  ARBs | 21.0 | 19.9 |
  Diuretics | 19.1 | 21.2 |
  Calcium antagonists | 27.6 | 27.4 |
  Combinations | 13.4 | 13.7 |