Frequency of hypoglycemia by BeAM category
| Baseline BeAM | Week 24 BeAM, mg/dL | |||||||
|---|---|---|---|---|---|---|---|---|
| <0 mg/dL | 0–50 mg/dL | >50 mg/dL | p Value* | <0 mg/dL | 0–50 mg/dL | >50 mg/dL | p Value* | |
| Exploratory analysis | ||||||||
| Symptomatic hypoglycemia | 223 (60.4) | 244 (54.7) | 223 (59.8) | 0.863 | – | 320 (54.4) | 370 (61.7) | 0.329 |
| Nocturnal hypoglycemia† | 97 (27.6) | 97 (23.1) | 101 (29.2) | 0.584 | – | 120 (21.2) | 175 (31.8) | 0.033 |
| Main analysis | ||||||||
| Symptomatic hypoglycemia | 74 (50.0) | 88 (50.9) | 97 (56.7) | 0.208 | – | 93 (43.7) | 166 (59.5) | 0.028 |
| Nocturnal hypoglycemia‡ | 32 (23.0) | 37 (23.1) | 45 (29.0) | 0.276 | – | 30 (14.6) | 84 (33.7) | <0.001 |
| Proof-of-concept analysis | ||||||||
| Symptomatic hypoglycemia | – | 38 (34.5) | 87 (46.0) | 0.029 | 19 (29.7) | 51 (42.9) | 55 (47.4) | 0.015 |
| Nocturnal hypoglycemia | – | 15 (13.6) | 45 (23.8) | 0.022 | 10 (15.6) | 24 (20.2) | 26 (22.4) | 0.152 |
The exploratory and main analyses included only patients with BeAM ≥0 mg/dL at week 24; the proof-of-concept analysis included only patients with BeAM ≥0 mg/dL at baseline.
All values n (%).
*Analyzed by a logistic regression model with source study and BeAM category as categorical variables.
†N=1117.
‡N=45.