TABLE 1

Overview of the DUAL I, III, V, VII, VIII, and IX Clinical Trials of IDegLira in Patients With Type 2 Diabetes

StudyTreatment Duration (weeks)PatientsComparatorChange in A1C, %: ETD IDegLira – Comparator (95% CI), PConfirmed Hypoglycemia: ERR IDegLira/Comparator (95% CI), PChange in Body Weight, kg:ETD IDegLira – Comparator (95% CI), PEOT Insulin Dose, units: ETD IDegLira – Comparator (95% CI), P
DUAL I (10)26Uncontrolled on metformin ± pioglitazone (n = 1,663)Insulin degludec (no dose cap)−0.47 (−0.58 to −0.36), <0.0001*0.68 (0.53–0.87), 0.0023−2.2 (−2.64 to −1.80), <0.0001−14.9 (−17.14 to −12.66), <0.0001
Liraglutide 1.8 mg−0.64 (−0.75 to −0.53), <0.00017.61 (5.17–11.21), <0.00012.4 (2.02–2.86), <0.0001NA
DUAL I extension (37)52Uncontrolled on metformin ± pioglitazone (n = 1,311)Insulin degludec (no dose cap)−0.46 (−0.57 to −0.34), <0.00010.63 (0.50–0.79), <0.0001−2.8 (NR), <0.0001−23.4 (−26.4 to −20.3), <0.0001
Liraglutide 1.8 mg−0.65 (−0.76 to −0.53), <0.00018.52 (6.09– 11.93), <0.00012.7 (NR), <0.0001NA
DUAL III (12)26Uncontrolled on GLP-1RA + metformin ± SU ± pioglitazone (n = 438)GLP-1RA−0.94 (−1.11 to −0.78), <0.00125.36 (10.6–60.5), <0.0012.9 (2.17–3.62), <0.001NA
DUAL V (14)26Uncontrolled on metformin + IGlar U100 20–50 units (n = 557)IGlar U100−0.59 (−0.74 to −0.45), <0.0010.43 (0.30–0.61), <0.001−3.2 (–3.77 to –2.64), <0.001−25.5 (−28.90 to −22.05), <0.001
DUAL VII (15)26Uncontrolled on metformin + IGlar U100 20–50 units (n = 506)IGlar U100 + insulin aspart−0.02 (−0.16 to 0.12), <0.0001*0.39 (0.29–0.51), <0.0001−3.6 (−4.2 to −2.9), <0.0001−44.5 (−48.3 to −40.7), <0.0001
DUAL VIII (36)104Uncontrolled on metformin, SU, glinide, pioglitazone, or DPP-4i (n = 1,012)IGlar U100NA0.44 (0.33–0.60), <0.0001−1.7 (−2.47 to −0.93), <0.0001−14.9 (−17.41 to −12.47), <0.0001
DUAL VIII, prespecified 26-week analysis (38)26Uncontrolled on metformin, SU, glinide, pioglitazone, or DPP-4i (n = 1,012)IGlar U100−0.47 (−0.58 to −0.36), <0.00010.56 (0.39–0.82), 0.0023−1.6 (−2.00 to −1.13), <0.0001−13.0 (−15.03 to −10.99), <0.0001
DUAL IX (32)26Uncontrolled on SGLT2i (n = 420)IGlar U100−0.36 (−0.50 to −0.21), <0.00010.42 (0.23–0.75), 0.0035−1.9 (−2.64 to −1.19), <0.0001−15.4 (−19.60 to −11.13), <0.0001
  • * Confirmed noninferiority of IDegLira.

  • Confirmed superiority of IDegLira.

  • This end point was not analyzed at week 104 in DUAL VIII. DPP-4i, DPP-4 inhibitor; ERR, estimated rate ratio; ETD, estimated treatment difference; GLP-1RA, GLP-1 receptor agonist; NA, not applicable; NR, not reported; OR, odds ratio; SGLT2i, SGLT2 inhibitor; SU, sulfonylurea.