Table 1.
Exenatide (N = 58) | Placebo (N = 24) | Total (N = 82) | |
---|---|---|---|
Age, years, mean ± SD (min, max) | 15 ± 1.9 (11, 17) | 16 ± 1.7 (12, 17) | 15 ± 1.8 (11, 17) |
Female sex | 31 (53.4) | 17 (70.8) | 48 (58.5) |
Region | |||
Europe | 8 (13.8) | 4 (16.7) | 12 (14.6) |
Middle East | 2 (3.4) | 1 (4.2) | 3 (3.7) |
North America | 35 (60.3) | 17 (70.8) | 52 (63.4) |
South America | 13 (22.4) | 2 (8.3) | 15 (18.3) |
Race | |||
White | 23 (39.7) | 12 (50.0) | 35 (42.7) |
Black or African American | 17 (29.3) | 8 (33.3) | 25 (30.5) |
Asian | 2 (3.4) | 1 (4.2) | 3 (3.7) |
Native Hawaiian or other Pacific Islander | 0 | 0 | 0 |
American Indian or Alaska Native | 4 (6.9) | 1 (4.2) | 5 (6.1) |
Other | 12 (20.7) | 2 (8.3) | 14 (17.1) |
Hispanic or Latino ethnic group | |||
Yes | 25 (46.3) | 8 (38.1) | 33 (44.0) |
No | 29 (53.7) | 13 (61.9) | 42 (56.0) |
Duration of diabetes, years, mean ± SD | 2 ± 2 | 3 ± 2 | 2 ± 2 |
Body weight, kg, mean ± SD | 102.2 ± 30.1 | 96.7 ± 22.7 | 100.6 ± 28.1 |
BMI, kg/m2, mean ± SD | 36.86 ± 9.28 | 35.14 ± 6.58 | 36.36 ± 8.57 |
Glycated hemoglobin, %, mean ± SD (mmol/mol) | 8.1 ± 1.2 (65.0) | 8.3 ± 1.5 (67.2) | 8.2 ± 1.3 (66.1) |
Fasting plasma glucose, mg/dL, mean ± SD | 165.0 ± 59.3 | 170.5 ± 60.4 | 166.6 ± 59.3 |
Prior antihyperglycemia treatment naive | 8 (13.8) | 2 (8.3) | 10 (12.2) |
Prior antihyperglycemia drug use | |||
Metformin only | 22 (37.9) | 11 (45.8) | 33 (40.2) |
Insulin only | 6 (10.3) | 1 (4.2) | 7 (8.5) |
Insulin and metformin | 21 (36.2) | 10 (41.7) | 31 (37.8) |
Metformin and a sulfonylurea | 1 (1.7) | 0 | 1 (1.2) |
Data are n (%) unless otherwise indicated. Baseline was defined as the last nonmissing assessment (scheduled or unscheduled) on or prior to the first dose of the randomized study medication. Percentages were calculated from the number of participants in the analysis set with nonmissing data, by treatment group and in total. max, maximum; min, minimum.