TABLE 1.

Overview of Trials Evaluating IDegLira and iGlarLixi in Patients With Type 2 Diabetes Uncontrolled on Basal Insulin or a GLP-1 Receptor Agonist

PopulationPatients With Type 2 Diabetes Uncontrolled on Basal InsulinPatients With Type 2 Diabetes Uncontrolled on a GLP-1 Receptor Agonist
TrialDual Ii (47)Dual V (48)Lixilan-L (50)Dual Iii (49)
PatientsType 2 diabetes uncontrolled on basal insulin + oral agents (n = 398)Type 2 diabetes uncontrolled on basal insulin glargine U100 + metformin (n = 557)Type 2 diabetes uncontrolled on basal insulin + oral agents (n = 736)Type 2 diabetes uncontrolled on GLP-1 receptor agonist + oral agents (n = 438)
Inclusion criteriaBasal insulin (20–40 units for ≥3 months) + metformin ± sulfonylurea or glinides; A1C: 7.5–10.0%; BMI ≥27 kg/m2Insulin glargine U100 (20–50 units for ≥56 days) + metformin; A1C 7.0–10.0%; BMI ≤40 kg/m2At run-in: basal insulin ≥6 months (stable dose of 15–40 units for ≥2 months) with ≤2 oral agents (metformin sulfonylurea, glinide, SGLT2 inhibitor, DPP-4 inhibitor); FPG ≤180 mg/dL if on 2 oral agents or 1 oral agent other than metformin; ≤200 mg/dL if on metformin or 0 oral agentsGLP-1 receptor agonist (maximum tolerated dose of liraglutide once daily or exenatide twice daily) + metformin ± sulfonylurea or pioglitazone; A1C 7.0–9.0%; BMI ≤40 kg/m2
At randomization: A1C 7.0–10.0%; FPG ≤140 mg/dL; insulin glargine U100 20–50 units; calcitonin ≤20 pg/mL; amylase/lipase levels <3 times ULN
Treatment groupsIDegLira + metformin; insulin degludec (maximum dose 50 units) + metforminIDegLira + metformin; insulin glargine U100 + metforminiGlarLixi + metformin; insulin glargine U100 + metforminIDegLira + metformin ± sulfonylurea ± pioglitazone; unchanged GLP-1 receptor agonist + metformin ± sulfonylurea ± pioglitazone
BlindingDouble-blindedOpen-labelOpen-labelOpen-label
Randomization1:11:11:12:1
Duration (weeks)2626Run-in: 6; after randomization: 3026
Baseline characteristics*
 Age (years)57–5858.4–59.159.6–60.358.3–58.4
 A1C (%)8.7–8.88.2–8.48.17.7–7.8
 BMI (kg/m2)33.6–33.831.731.0–31.332.9–33.0
 Diabetes duration (years)10–1111.3–11.612.0–12.110.4
 Basal insulin dose (units)2931–3235NA
Completers (%)IDegLira: 85; insulin degludec: 83IDegLira: 89.9; insulin glargine U100: 95.0iGlarLixi: 91.6; insulin glargine U100: 96.2IDegLira: 94.5; unchanged GLP-1 receptor agonist: 80.1
Starting doseIDegLira: 16 units; insulin degludec: 16 unitsIDegLira: 16 units; insulin glargine U100: pretrial doseiGlarLixi: 20 units/10 mg (given with pen A) if the insulin glargine U100 dose was <30 units at the end of run-in or 30 units/10 mg (given with pen B) if the insulin glargine U100 dose was ≥30 units at the end of the run-in; insulin glargine U100: pretrial doseIDegLira: 16 units; unchanged GLP-1 receptor agonist: pretrial dose
Titration frequencyTwice weeklyTwice weeklyOnce weeklyTwice weekly
FPG titration target (mg/dL)72–9072–9080–10072–90
  • * Range of mean values across treatments.

  • DPP-4, dipeptidyl peptidase 4;

  • NA, not applicable;

  • SGLT2, sodium–glucose cotransporter 2;

  • ULN, upper limit of normal.