Table 1.
Demographic data and baseline characteristics of participants
| 5 mg empagliflozin | 10 mg empagliflozin | 25 mg empagliflozin | Total | |
|---|---|---|---|---|
| Number of participants, n (%) | 9 (100) | 8 (100) | 10 (100) | 27 (100) |
| Sex, n (%) | ||||
| Male | 3 (33.3) | 3 (37.5) | 3 (30.0) | 9 (33.3) |
| Female | 6 (66.7) | 5 (62.5) | 7 (70.0) | 18 (66.7) |
| Race, n (%) | ||||
| American Indian/Alaska Native | 0 | 3 (37.5) | 0 | 3 (11.1) |
| Asian | 1 (11.1) | 0 | 0 | 1 (3.7) |
| Black/African American | 3 (33.3) | 4 (50.0) | 4 (40.0) | 11 (40.7) |
| Hawaiian/Pacific Isle | 0 | 0 | 0 | 0 |
| White | 5 (55.6) | 1 (12.5) | 6 (60.0) | 12 (44.4) |
| Mean (sd) age, years | 13.7 (2.0) | 14.5 (1.9) | 14.2 (2.1) | 14.1 (2.0) |
| Mean (sd) weight, kg | 90.0 (19.0) | 111.0 (21.3) | 91.1 (25.7) | 96.7 (23.5) |
| Mean (sd) BMI, kg/m2 | 33.9 (5.8) | 39.6 (6.2) | 33.7 (7.0) | 35.5 (6.7) |
| Mean (sd) BMI SDS | 2.9 (0.7) | 3.4 (0.5) | 2.8 (0.9) | 3.0 (0.8) |
| Smoking status, n (%) | ||||
| Never smoked | 9 (100) | 8 (100) | 9 (90.0) | 26 (96.3) |
| Ex‐smoker | 0 | 0 | 0 | 0 |
| Currently smokes | 0 | 0 | 1 (10.0) | 1 (3.7) |
| Follow diet/exercise recommendation, n (%) | ||||
| No | 2 (22.2) | 1 (12.5) | 1 (10.0) | 4 (14.8) |
| Yes | 7 (77.8) | 7 (87.5) | 9 (90.0) | 23 (85.2) |
| Background therapy, n (%) | ||||
| None | 1 (11.1) | 3 (37.5) | 2 (20.0) | 6 (22.2) |
| Metformin alone | 5 (55.6) | 3 (37.5) | 6 (60.0) | 14 (51.9) |
| Insulin alone | 0 | 0 | 0 | 0 |
| Metformin and insulin | 3 (33.3) | 2 (25.0) | 2 (20.0) | 7 (25.9) |
| Mean (sd) eGFR, ml/min/1.73m2 | 178.3 (17.4) | 162.3 (38.8) | 157.3 (15.2) | 165.8 (25.8) |
| Mean (sd) urinary glucose excretion, g/24 h | 16.2 (30.3)a | 12.3 (25.4) | 0.08 (0.05) | 8.8 (22.1) |
| Mean (sd) HbA1c, mmol/mol | 57 | 57 | 45 | 53 |
| Mean (sd) HbA1c, % | 7.4 (1.4) | 7.4 (1.1) | 6.3 (1.0) | 7.0 (1.2) |
| Mean (sd) FPG, mmol/mol | 8.5 (4.2) | 8.6 (3.1) | 6.4 (1.4) | 7.7 (3.1) |
| Tanner scale score, n (%) | ||||
| 1 | 0 | 0 | 0 | 0 |
| 2 | 0 | 1 (12.5) | 0 | 1 (3.7) |
| 3 | 1 (11.1) | 1 (12.5) | 1 (10.0) | 3 (11.1) |
| 4 | 2 (22.2) | 4 (50.0) | 1 (10.0) | 7 (25.9) |
| 5 | 6 (66.7) | 2 (25.0) | 8 (80.0) | 16 (59.3) |
SDS, standard deviation score; eGFR, estimated GFR; FPG, fasting plasma glucose.
a
*Mean baseline urinary glucose excretion in the 5‐mg dose group was based on the data of only eight participants, as the pre‐dose urine collection of one participant was incomplete.