Table 5.
Results from the main analysis: 4-arm model with 56 patients in the basal–bolus arm
| (a) Estimated responder rates per treatment arm, based on a logistic regression model | ||||
|---|---|---|---|---|
| IDegLira (N = 199) | GLP-1RA add-on to basal insulin (N = 225) | Basal–bolus (N = 56) | Basal-only (glargine) (N = 329) | |
| ΔHbA1c in all subjects, % | −1.68 | −1.33 | −1.39 | −1.03 |
| ΔHbA1c in all subjects, mmol/mol | −18 | −15 | −15 | −11 |
| HbA1c <7.0% (53 mmol/mol) | 64.7% | 47.1% | 52.8% | 31.9% |
| HbA1c <7.0% without hypoglycemia | 45.6% | 35.5% | 5.0% | 15.6% |
| HbA1c <7.0% without hypoglycemia and no weight gain | 39.1% | 33.2% | 0% | 7.7% |
| (b) Estimated odds ratios for responder rates for IDegLira versus comparators in all subjects, based on a logistic regression model | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| In all subjects | IDegLira versus GLP-1RA add-on to basal insulin | IDegLira versus basal–bolus with insulin glargine as basal component | IDegLira versus basal-only (up-titrated insulin glargine) | ||||||
| Odds ratio | 95% CI | P value | Odds ratio | 95% CI | P value | Odds ratio | 95% CI | P value | |
| HbA1c <7.0% (53 mmol/mol) | 2.06 | (1.28; 3.31) | 0.003 | 1.64 | (0.86; 3.12) | 0.13 | 3.91 | (2.58; 5.93) | <0.0001 |
| HbA1c <7.0% without hypoglycemia | 1.53 | (0.95; 2.47) | 0.084 | 16.05 | (4.71; 54.66) | <0.0001 | 4.53 | (2.87; 7.14) | <0.0001 |
| HbA1c <7.0% without hypoglycemia and no weight gain | 1.29 | (0.77; 2.14) | 0.33 | NA | NA | NA | 7.71 | (4.50; 13.19) | <0.0001 |
Rates are shown as percentage of patients, except for HbA1c changes
NA not applicable; insufficient data to estimate due to estimated 0% of patients in the basal–bolus arm (with insulin glargine as a basal component) who achieved HbA1c <7.0%, without hypoglycemia and no weight gain
Δ change from baseline, GLP-1RA glucagon-like peptide-1 receptor agonist, HbA 1c glycated hemoglobin, IDegLira insulin degludec/liraglutide