Table 1.
Baseline Demographics and Disease Characteristics of the Study Population (N = 36)
| T2DM Subjects | |||||
|---|---|---|---|---|---|
| Normal Renal Function (n = 6) | Mild Renal Impairment (n = 8) | Moderate Renal Impairment (n = 8) | Severe Renal Impairment (n = 6) | Healthy Subjects With Normal Renal Function (n = 8) | |
| Sex, n | |||||
| Male | 5 | 3 | 4 | 6 | 5 |
| Female | 1 | 5 | 4 | 0 | 3 |
| Mean age, years (SD) | 63.2 (3.5) | 66.4 (2.4) | 65.8 (7.9) | 61.2 (10.3) | 64.3 (3.9) |
| Range | 60‐68 | 63‐70 | 54‐76 | 49‐76 | 60‐70 |
| Race, n | |||||
| White | 6 | 7 | 8 | 4 | 6 |
| Black | 0 | 1 | 0 | 2 | 2 |
| Mean HbA1c, % (SD) | 7.9 (1.42) | 7.1 (1.49) | 7.1 (0.76) | 7.1 (1.13) | 5.5 (0.19) |
| Range | 6.0‐10.1 | 4.6‐9.1 | 6.1‐8.3 | 6.1‐9.3 | 5.2‐5.8 |
| Mean weight, kg (SD) | 95.2 (4.7) | 87.8 (18.1) | 86.3 (18.8) | 105.5 (19.3) | 86.0 (3.5) |
| Range | 88.6‐102.6 | 58.9‐113.8 | 65.4‐128.2 | 86.2‐132.2 | 82.6‐93.2 |
| Mean BMI,a kg/m2 (SD) | 31.9 (3.9) | 31.9 (5.7) | 32.3 (4.4) | 35.1 (4.7) | 28.3 (2.5) |
| Range | 28.0‐38.6 | 19.7‐37.7 | 26.2‐40.4 | 29.6‐40.5 | 24.0‐32.3 |
| Mean BSA‐unnormalized eGFR at screening,b mL/min (SD) | 111.1 (15.61) | 72.3 (4.52) | 40.3 (4.30) | 20.9 (8.38) | 102.6 (10.04) |
| Range | 94.9‐138.9 | 66.3‐79.4 | 32.9‐46.0 | 9.2‐29.6 | 91.2‐116.8 |
| Prior and concomitant treatments for diabetes mellitus, n | |||||
| Insulin | 0 | 0 | 8 | 7 | … |
| Sulfonylureas | 2 | 1 | 3 | 1 | … |
| Metformin | 6 | 7 | 0 | 0 | … |
| Sitagliptin plus Metforminc | 0 | 1 | 0 | 0 | … |
| Sitagliptin | 0 | 0 | 1 | 0 | … |
Normal renal function, eGFR ≥90 mL/min; mild renal impairment, eGFR 60‐89 mL/min; moderate renal impairment, eGFR 30‐59 mL/min; severe renal impairment eGFR <30 mL/min. BMI, body mass index; BSA, body surface area; eGFR, estimated glomerular filtration rate; HbA1c, hemoglobin A1c; n, number of subjects; …, not applicable; SD, standard deviation; T2DM, type 2 diabetes mellitus.
aBMI was calculated as weight [kg]/(height [cm] × 0.01)2.
bAverage of the 2 screening eGFR values that were based on serum creatinine values obtained on 2 occasions separated by at least 72 hours to 14 days during the screening period.
cAs a fixed‐dose combination.