Table 2.
Change in Body Weight by Baseline Characteristic.
| Baseline characteristics | Week 26, N |
Body weight, change from baseline,
kg |
ETD [95% CI] | Subgroup
interaction P-value |
||
|---|---|---|---|---|---|---|
| IDegLira | Basal-bolus | IDegLira | Basal-bolus | |||
| HbA1c | ||||||
| ≤58.5 mmol/mol | 54 | 54 | −1.03 (3.16) | 2.15 (3.21) | −3.12 [−4.42; −1.83] | .2472 |
| >58.5 to ≤69.4 mmol/mol | 107 | 101 | −1.12 (3.27) | 2.05 (3.58) | −3.23 [−4.16; −2.30] | |
| >69.4 mmol/mol | 77 | 78 | −0.54 (3.23) | 3.75 (4.01) | −4.31 [−5.38; −3.23] | |
| BMI | ||||||
| <30 kg/m2 | 92 | 89 | −1.09 (2.68) | 2.30 (3.70) | −3.36 [−4.37; −2.36] | .7399 |
| 30 to <35 kg/m2 | 94 | 81 | −0.97 (3.13) | 2.39 (3.39) | −3.47 [−4.50; −2.45] | |
| ≥35 kg/m2 | 52 | 63 | −0.52 (4.20) | 3.44 (4.07) | −3.98 [−5.25; −2.72] | |
| Age | ||||||
| <65 years | 170 | 185 | −0.83 (3.28) | 2.63 (3.75) | −3.57 [−4.29; −2.86] | .9536 |
| ≥65 years | 68 | 48 | −1.13 (3.12) | 2.67 (3.65) | −3.53 [−4.81; −2.25] | |
| Diabetes duration | ||||||
| <10 years | 90 | 83 | −0.51 (3.50) | 2.84 (3.70) | −3.40 [−4.43; −2.38] | .6724 |
| ≥10 years | 148 | 150 | −1.16 (3.04) | 2.53 (3.73) | −3.68 [−4.46; −2.90] | |
| Total pretrial daily basal insulin dose | ||||||
| 20to <30 U | 91 | 96 | −0.06 (3.22) | 2.84 (3.90) | −2.80 [−3.77; −1.83] | .0326 |
| 30 to <40 U | 56 | 61 | −0.42 (2.70) | 2.60 (2.96) | −3.03 [−4.26; −1.80] | |
| 40 to ≤50 U | 91 | 76 | −2.07 (3.23) | 2.42 (4.06) | −4.59 [−5.62; −3.56] | |
| FPG | ||||||
| <7.2 mmol/L | 86 | 82 | −1.15 (3.22) | 1.95 (3.57) | −3.06 [−4.10; −2.03] | .2089 |
| ≥7.2 mmol/L | 151 | 151 | −0.84 (3.19) | 3.01 (3.76) | −3.89 [−4.66; −3.12] | |
Data are mean (SD) unless otherwise stated. Changes from baseline are absolute changes using descriptive statistics based on the FAS. All postbaseline body weight measurements obtained at planned visits before discontinuation from randomized treatment were analyzed using a linear mixed normal model using an unstructured residual covariance matrix for body weight measurements within the same participant. The model included subgroup, treatment, visit, and region as fixed factors and baseline body weight as covariate. The interactions between subgroup*treatment*visit, region*visit, and baseline HbA1c*visit were included in the model.
Basal-bolus, insulin glargine 100 U/mL + insulin aspart; BMI, body mass index; ETD, estimated treatment difference; FAS, full analysis set; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; IDegLira, insulin degludec/liraglutide; N, number of participants; SD, standard deviation; U, units.