Baseline demographic and clinical characteristics for pooled patients
| Linagliptin | Placebo | |
|---|---|---|
| Demographic | ||
| Number of patients (TS) | 478 | 267 |
| Sex, n (%) | ||
| Male | 213 (44.6) | 117 (43.8) |
| Female | 265 (55.4) | 150 (56.2) |
| Country, n (%) | ||
| Argentina | 271 (56.7) | 155 (58.1) |
| Brazil | 22 (4.6) | 25 (9.4) |
| Canada | 3 (0.6) | 0 (0.0) |
| Mexico | 126 (26.4) | 49 (18.4) |
| Peru | 3 (0.6) | 2 (0.7) |
| USA | 53 (11.1) | 36 (13.5) |
| Age, years, mean (SD) | 57.4 (10.0) | 56.8 (9.7) |
| Body mass index, kg/m2, mean (SD) | 30.3 (5.0) | 31.4 (4.6) |
| Waist circumference, cm, mean (SD)* | 100.9 (12.1) | 103.8 (12.0) |
| eGFR, n (%) | ||
| ≥90 mL/min/1.73 m2 | 276 (57.7) | 142 (53.2) |
| 60 to <90 mL/min/1.73 m2 | 167 (34.9) | 101 (37.8) |
| 30 to <60 mL/min/1.73 m2 | 32 (6.7) | 21 (7.9) |
| <30 mL/min/1.73 m2 | 3 (0.6) | 3 (1.1) |
| Clinical | ||
| Number of patients (FAS) | 467 | 264 |
| HbA1c, per cent, mean (SD) | 8.25 (0.85) | 8.23 (0.92) |
| FPG, mg/dL, mean (SD)† | 161.4 (46.3) | 156.1 (44.4) |
| 2 h postprandial glucose, mg/dL, mean (SD)‡ | 265.9 (65.8) | 259.9 (65.6) |
| Time since diagnosis, n (%) | ||
| ≤1 year | 24 (5.1) | 19 (7.2) |
| >1 to 5 years | 125 (26.8) | 57 (21.6) |
| >5 years | 318 (68.1) | 188 (71.2) |
| Number of previous antidiabetes treatments, n (%) | ||
| 0 | 20 (4.3) | 16 (6.1) |
| 1 | 135 (28.9) | 62 (23.5) |
| 2 | 302 (64.7) | 175 (66.3) |
| 3 | 10 (2.1) | 11 (4.2) |
| Antidiabetes treatment at enrollment, n (%) | ||
| No treatment | 20 (4.3) | 16 (6.1) |
| Metformin | 70 (15.0) | 20 (7.6) |
| Sulfonylurea | 35 (7.5) | 16 (6.1) |
| α-glucosidase inhibitor | 1 (0.2) | 0 (0.0) |
| Insulin | 29 (6.2) | 26 (9.8) |
| Metformin and sulfonylurea | 216 (46.3) | 73 (27.7) |
| Metformin and glinide | 1 (0.2) | 0 (0.0) |
| Metformin and DPP-4 inhibitor | 4 (0.9) | 1 (0.4) |
| Metformin and insulin | 79 (16.9) | 98 (37.1) |
| Glitazone and insulin | 2 (0.4) | 3 (1.1) |
| Metformin, sulfonylurea, and α-glucosidase inhibitor | 1 (0.2) | 0 (0.0) |
| Metformin, glitazone, and insulin | 9 (1.9) | 11 (4.2) |
*Linagliptin, n=477; placebo, n=266.
†Linagliptin, n=442; placebo, n=250.
‡Meal tolerance test set: linagliptin, n=28; placebo, n=9.
DPP-4, dipeptidyl peptidase-4 inhibitor; eGFR, estimated glomerular filtration rate, according to the Modification of Diet in Renal Disease study equation; FAS, full analysis set; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; TS, treated set.