Table 1.
Baseline characteristics of the participants – Treated set
| Characteristic | Placebo (N=53) |
Empagliflozin pooled (N=52) |
Linagliptin 5 mg (N=52) |
Total (N=157) |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Male | 19 (35·8) | 19 (36·5) | 22 (42·3) | 60 (38·2) |
| Female | 34 (64·2) | 33 (63·5) | 30 (57·7) | 97 (61·8) |
| Region, n (%) | ||||
| North America | 34 (64·2) | 36 (69·2) | 37 (71·2) | 107 (68·2) |
| South America | 11 (20·8) | 9 (17·3) | 7 (13·5) | 27 (17·2) |
| Europe | 7 (13·2) | 6 (11·5) | 5 (9·6) | 18 (11·5) |
| Asia | 1 (1·9) | 1 (1·9) | 3 (5·8) | 5 (3·2) |
| Race, n (%) | ||||
| American Indian or Alaska Native | 1 (1·9) | 4 (7·7) | 3 (5·8) | 8 (5·1) |
| Asian | 3 (5·7) | 2 (3·8) | 4 (7·7) | 9 (5·7) |
| Black or African American | 17 (32·1) | 19 (36·5) | 13 (25·0) | 49 (31·2) |
| Native Hawaiian or Other Pacific Islander | 1 (1·9) | 0 (0·0) | 2 (3·8) | 3 (1·9) |
| White | 29 (54·7) | 23 (44·2) | 26 (50·0) | 78 (49·7) |
| All other | 2 (3·8) | 4 (7·7) | 4 (7·7) | 10 (6·4) |
| Ethnicity, n (%) | ||||
| Non-Hispanic or Latino | 32 (60·4) | 35 (67·3) | 30 (57·7) | 97 (61·8) |
| Hispanic or Latino | 21 (39·6) | 17 (32·7) | 22 (42·3) | 60 (38·2) |
| Age, years, mean ± SD | 14·6 ± 1·8 | 14·4 ± 1·9 | 14·6 ± 1·9 | 14·5 ± 1·9 |
| Median (range) | 14·0 (11, 17) | 13·0 (10, 17) | 14·5 (10, 17) | 14·0 (10, 17) |
| Time since diagnosis of diabetes, n (%) | ||||
| <1 year | 18 (34·0) | 17 (32·7) | 16 (30·8) | 51 (32·5) |
| 1 to 3 years | 24 (45·3) | 21 (40·4) | 21 (40·4) | 66 (42·0) |
| >3 years | 11 (20·8) | 14 (26·9) | 15 (28·8) | 40 (25·5) |
| BMI, kg/m2, mean ± SD | 36·07 ± 10·07 | 35·54 ± 7·17 | 36·50 ± 7·55 | 36·04 ± 8·33 |
| Median (range) | 34·62 (65·1, 19·6) | 34·48 (21·1, 56·2) | 34·83 (20·5, 55·2) | 34·65 (19·6, 65·1) |
| BMI z-score, n (%) | ||||
| >2 to ≤3 (Class 1 obesity) | 17 (32·1) | 21 (40·4) | 20 (38·5) | 58 (36·9) |
| >3 (Class 2 to 3 obesity) | 27 (50·9) | 26 (50·0) | 28 (53·8) | 81 (51·6) |
| Weight, kg, mean ± SD | 98·38 ± 29·55 | 98·66 ± 24·35 | 102·76 ± 26·40 | 99·92 ± 26·78 |
| Median (range) | 94·00 (50·7, 168·0) | 93·95 (42·5, 157·0) | 97·55 (43·2, 171·0) | 94·10 (171·0, 42·5) |
| Blood pressure, mean ± SD* | ||||
| SBP | 118·13 ± 11·85 | 120·23 ± 9·97 | 122·31 ± 10·97 | |
| DBP | 72·22 ± 9·27 | 72·03 ± 8·38 | 73·78 ± 8·08 | |
| Fasting C-peptide, nmol/L, mean ± SD | 0·8967 ± 0·4311 | 0·9598 ± 0·5302 | 1·1245 ± 0·6269 | 0·9932 ± 0·5400 |
| Median (range) | 0·8432 (0·036, 1·743) | 0·8449 (0·056, 3·092) | 0·9934 (0·165, 2·980) | 0·8977 (0·036, 3·092) |
| eGFR (Zappitelli), mL/min/1.73 m2, mean ± SD | 124·28 ± 22·96 | 130·09 ± 26·78 | 135·11 ± 36·42 | 129·79 ± 29·39 |
| Median (range) | 123·39 (85·2, 180·0) | 124·62 (90·5, 241·4) | 122·59 (91·3, 282·7) | 123·39 (85·2, 282·7) |
| Tanner scoring score, n (%) | ||||
| 1 | 0 (0·0) | 0 (0·0) | 0 (0·0) | 0 (0·0) |
| 2 to 4 | 21 (39·6) | 24 (46·2) | 19 (36·5) | 64 (40·8) |
| 5 | 32 (60·4) | 28 (53·8) | 33 (63·5) | 93 (59·2) |
| HbA1c, %, mean ± SD | 8·05 ± 1·23 | 8·00 ± 1·29 | 8·05 ± 1·11 | 8·03 ± 1·20 |
| HbA1c, n (%) | ||||
| <8.5% | 37 (69·8) | 36 (69·2) | 31 (59·6) | 104 (66·2) |
| ≥8.5% | 16 (30·2) | 16 (30·8) | 21 (40·4) | 53 (33·8) |
| FPG, mg/dL, mean ± SD | 158·6 ± 53·8 | 154·4 ± 57·8 | 162·8 ± 56·0 | 158·7 ± 55·6 |
| Median (range) | 151·6 (50, 293) | 143·0 (44, 331) | 157·1 (84, 314) | 150·1 (44, 331) |
*
Data quoted from descriptive analyses over time by treatment, which did not include study totals.
To convert the values for % HbA1c to millimoles per mol, subtract 2·15 and multiply the result by 10·929. To convert the values for plasma glucose to millimoles per liter, multiply by 0·05551. The BMI is the weight in kilograms divided by the square of the height in metres. BMI, body mass index; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate; FPG, fasting plasma glucose, HbA1c, glycated haemoglobin; mITT, modified intention-to-treat; SBP, systolic blood pressure; SD, standard deviation.