Table 1.
Patient demographics and baseline characteristics
| Parameter | Linagliptin [19, 20] | Saxagliptin [17] | Sitagliptina [16] | Vildagliptin [14] | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall RI | Severe RI | Overall RI | Overall RI | Moderate RI | Severe RI | |||||||
| Active (n = 113) | PBO (n = 122) | Active (n = 68) | PBO (n = 65) | Active (n = 85) | PBO (n = 85) | Active (n = 65) | PBO (n = 26) | Active (n = 165) | PBO (n = 129) | Active (n = 124) | PBO (n = 97) | |
| Age (years) | 66.6 ± 9.3 | 64.0 ± 10.9 | 64.9 ± 9.6 | 66.8 ± 8.3 | 66.2 ± 9.1 | 68.9 ± 9.8 | 65.3 ± 9.7 | 67.7 ± 8.8 | 69.7 ± 7.3 | 64.1 ± 9.2 | 64.5 ± 10.8 | |
| Men, n (%) or % | 63.4% | 45 (66.2) | 35 (53.8) | 32 (37.6) | 41 (48.2) | 31 (48.0) | 16 (62.0) | 96 (58.2) | 80 (62.0) | 65 (52.4) | 53 (54.6) | |
| Race, n (%) or % | ||||||||||||
| Europid/White | 70.2% | 53 (77.9) | 45 (69.2) | 85 (100) | 85 (100) | 22 (34.0) | 8 (31.0) | 116 (70.3) | 94 (72.9) | 61 (49.2) | 49 (50.4) | |
| Asian (Indian subcontinent) | – | 8b (11.8) | 11b (16.9) | – | – | 20b (31.0) | 7b (27.0) | 24 (14.5) | 15 (11.6) | 22 (17.7) | 21 (21.6) | |
| Asian (non-Indian subcontinent) | – | – | – | – | – | – | – | 0 (0.0) | 0 (0.0) | 2 (1.6) | 0 (0.0) | |
| Hispanic/Latino | – | – | – | – | – | 17 (26.0) | 9 (35.0) | 21 (12.7) | 16 (12.4) | 36 (29.0) | 26 (26.8) | |
| Black | – | 6 (8.8) | 7 (10.8) | – | – | 4 (6.0) | 1 (4.0) | 2 (1.2) | 0 (0.0) | 2 (1.6) | 0 (0.0) | |
| Other | – | 2 (3.1) | 1 (1.5) | – | – | 2 (3.0) | 1 (4.0) | 2 (1.2) | 4 (3.1) | 1 (0.8) | 1 (1.0) | |
| BMI (kg/m2) | – | 32.3 ± 5.8 | 31.7 ± 5.9 | 31.2 ± 6.1 | 30.2 ± 6.8 | 26.5 ± 4.0 | 26.9 ± 4.5 | 30.2 ± 5.1 | 30.0 ± 5.0 | 30.2 ± 5.6 | 29.5 ± 5.0 | |
| HbA1c (%) | 8.1 ± 0.9 | 8.2 ± 1.1 | 8.2 ± 0.9 | 8.5 ± 1.2 | 8.1 ± 1.1 | 7.6 ± 0.9 | 7.8 ± 0.9 | 7.8 ± 1.0 | 7.8 ± 0.9 | 7.7 ± 1.0 | 7.7 ± 1.0 | |
| FPG (mmol/L) | – | 8.3 ± 4.4 | 8.9 ± 3.6 | 10.4 ± 3.9 | 9.4 ± 3.3 | 8.9 ± 2.7 | 8.6 ± 2.0 | 9.1 ± 3.3 | 8.4 ± 2.7 | 8.1 ± 2.8 | 8.6 ± 3.4 | |
| Duration of T2DM (years) | – | – | – | 15.1 ± 7.5 | 18.2 ± 8.5 | 13.6 ± 9.7 | 13.2 ± 8.9 | 15.0 ± 9.1 | 15.2 ± 10.0 | 17.3 ± 8.6 | 19.0 ± 9.6 | |
| >5 years, n (%) | – | 64 (97.0) | 59 (95.2) | – | – | – | – | – | – | – | – | |
| Current diabetes therapy, n (%) or % | ||||||||||||
| Any | – | – | – | 83 (97.6) | 84 (98.8) | 159 (96.4) | 124 (96.1) | 119 (96.0) | 96 (99.0) | |||
| Insulin | 86% | 39 (57.4) | 46 (70.8) | 71 (83.5) | 57 (67.1) | 7 (10.8) | 2 (7.7) | 95 (57.6) | 68 (52.7) | 87 (70.2) | 66 (68.0) | |
| Insulin and OAD | – | 15 (22.1) | 9 (13.8) | 11 (12.9) | 3 (3.5) | – | – | 18 (10.9) | 20 (15.5) | 13 (10.5) | 12 (12.4) | |
| Any OAD | – | 14 (20.6) | 10 (15.3) | 23 (27.1) | 30 (35.3) | 44 (68.0) | 18 (69.0) | 46 (27.8) | 36 (27.9) | 19 (15.3) | 18 (18.5) | |
| Renal disease measures | ||||||||||||
| eGFR (MDRD) (mL/min/1.73 m2) | 37.2 (SD, NA) | 22.1 ± 6.3 | 25.1 ± 6.9 | – | – | – | – | 39.3 ± 6.0 | 40.3 ± 5.8 | 21.9 ± 5.7 | 20.9 ± 6.4 | |
| Stratum 1, n (%) | – | – | – | 48 (56.5) | 42 (49.4) | 37 (57.0) | 15 (58.0) | – | – | – | – | |
| Stratum 2, n (%) | – | – | – | 37 (43.6) | 43 (50.6) | 28 (43.0) | 11 (42.0) | – | – | – | – | |
| CrCL (mL/min) | – | – | – | 31.5 ± 1.5 | 30.4 ± 1.4 | – | – | – | – | – | – | |
Data are expressed as mean ± SD, unless stated otherwise
Stratum 1: Patients with moderate renal insufficiency (CrCL ≥30 to <50 mL/min and not on dialysis)
Stratum 2: Patients with severe renal insufficiency (CrCL <30 mL/min and not on dialysis) or end-stage renal disease on dialysis
BMI body mass index, CrCL creatinine clearance, eGFR estimated glomerular filtration rate, FPG fasting plasma glucose, HbA1c glycated hemoglobin, MDRD Modification of Diet in Renal Disease, NA not available, OAD oral antidiabetes drug, PBO placebo, RI renal impairment, SD standard deviation, T2DM type 2 diabetes mellitus
aPatients in the sitagliptin study were either not on OAD or were subjected to washout during the run-in period; insulin monotherapy was allowed
bAsian people of Indian and non-Indian subcontinents are not distinguished