Table 3.
Hypoglycemia
| Albiglutide + glargine | Lispro + glargine | |
|---|---|---|
| Hypoglycemia (full analysis population) incidence to week 26 | ||
| n | 402 | 412 |
| Documented symptomatic or severe | ||
| Participants, n (%) | 230 (57.2) | 309 (75.0) |
| Odds ratio (95% CI)* | 0.43 (0.31–0.60)*** | |
| On-therapy hypoglycemia (safety population) exposure-adjusted incidence rate | ||
| n | 400 | 413 |
| Asymptomatic | ||
| Participants, n (%) | 230 (57.5) | 293 (70.9) |
| Events/person-year† | 6.6 | 12.6 |
| Documented symptomatic | ||
| Participants, n (%) | 203 (50.8) | 299 (72.4) |
| Events/person-year† | 6.3 | 19.5 |
| Severe | ||
| Participants, n (%) | 9 (2.3) | 22 (5.3) |
| Events/person-year† | 0.05 | 0.13 |
| All‡ | ||
| Participants, n (%) | 290 (72.5) | 359 (86.9) |
| Events/person-year† | 13.0 | 32.2 |
| Rate ratio (95% CI)§ | 0.43 (0.36–0.52)††† | |
| On-therapy hypoglycemic event by blood glucose level‖ | ||
| n | 400 | 413 |
| <56 mg/dL (<3.1 mmol/L), n (%) | 141 (35.3) | 239 (57.9) |
| ≥56 mg/dL (≥3.1 mmol/L), n (%) | 160 (40.0) | 121 (29.3) |
| Missing data, n (%) | 4 (1.0) | 1 (0.2) |
Difference from lispro + glargine group based on nonparametric CMH test after adjustment for baseline HbA1c category, age category, region, and current use of metformin.
Exposure-adjusted event rate (number of on-therapy severe or documented symptomatic hypoglycemic or asymptomatic events divided by person-years), where person-years is defined as the cumulative study treatment exposure duration (in years) for all participants in the treatment group during the treatment period being summarized.
Severe, documented symptomatic, or asymptomatic hypoglycemia event.
Ratio of LS incidence rate (albiglutide/insulin lispro) from repeated-measure Poisson regression model with offset for the person-year. The model includes treatment effect and interval as factors and HbA1c stratum, age category (<65 vs. ≥65 years), current use of metformin (yes vs. no), and region as covariates. The P value is from a two-sided t test for the difference in rates.
Participants with more than one hypoglycemic event are only counted once in the worst category.
P < 0.0001 with the nonparametric CMH test;
P = 0.0001 with repeated-measures Poisson regression.