Table 1.
Baseline demographics and clinical characteristics
| Linagliptin | Placebo | |
|---|---|---|
| Patients (treated seta), N | 52 | 50 |
| Male | 34 (65.4) | 36 (72.0) |
| Age, years, mean (SD) | 71.1 (5.5) | 71.5 (5.6) |
| ≥ 60 to < 65 years, n (%) | 7 (13.5) | 4 (8.0) |
| ≥ 65 to < 70 years, n (%) | 10 (19.2) | 14 (28.0) |
| ≥ 70 to < 75 years, n (%) | 24 (46.2) | 19 (38.0) |
| ≥ 75 years, n (%) | 11 (21.2) | 13 (26.0) |
| BMI, kg/m−2, mean (SD) | 23.9 (3.3) | 22.9 (3.0) |
| eGFR (MDRD), ml/min/1.73 m2, mean (SD) | 59.9 (14.0) | 62.7 (11.1) |
| ≥ 90 ml/min/1.73 m2, n (%) | 1 (1.9) | 0 (0.0) |
| ≥ 60 to < 90 ml/min/1.73 m2, n (%) | 22 (42.3) | 31 (62.0) |
| ≥ 45 to < 60 ml/min/1.73 m2, n (%) | 22 (42.3) | 16 (32.0) |
| ≥ 30 to < 45 ml/min/1.73 m2, n (%) | 7 (13.5) | 3 (6.0) |
| Patients (full analysis setb), N | 51 | 50 |
| HbA1c, %, mean (SD) | 8.1 (0.8) | 8.0 (0.7) |
| < 7.0, n (%) | 2 (3.9) | 1 (2.0) |
| ≥ 7.0 to < 7.5, n (%) | 10 (19.6) | 9 (18.0) |
| ≥ 7.5 to < 8.0, n (%) | 14 (27.5) | 14 (28.0) |
| ≥ 8.0 to < 9.0, n (%) | 17 (33.3) | 22 (44.0) |
| ≥ 9.0, n (%) | 8 (15.7) | 4 (8.0) |
| FPG, mg/dl, mean (SD) | 130.8 (31.4) | 127.6 (37.6) |
| Time since diagnosis of diabetes, n (%) | ||
| ≤ 1 year | 2 (3.9) | 0 (0.0) |
| > 1 to ≤ 5 years | 4 (7.8) | 3 (6.0) |
| > 5 to ≤ 10 years | 8 (15.7) | 13 (26.0) |
| > 10 to ≤ 15 years | 13 (25.5) | 12 (24.0) |
| > 15 years | 24 (47.1) | 22 (44.0) |
BMI body mass index, eGFR estimated glomerular filtration rate, FPG fasting plasma glucose, HbA1c glycated haemoglobin, SD standard deviation
aAll patients who were treated with ≥ 1 dose of study medication
bAll patients who were treated with ≥ 1 dose of study medication and had a baseline and ≥ 1 on-treatment HbA1c measurement