TABLE 4.

Comparison of Efficacy Results in Pivotal Trials Evaluating Co-Formulations of a Basal Insulin and a GLP-1 Receptor Agonist

DUAL I Extension (34)DUAL IV (40)DUAL VI (41)LixiLan-O (37)
Change in A1C (percentage points)IDegLira: –1.84 IDeg: –1.40 Lira: –1.21IDegLira: –1.5 Placebo: –0.5IDegLira 1WT: –2.01 IDegLira 2WT: – 2.02iGlarLixi: –1.6 IGlar: –1.3 Lixi: –0.9
ETD –0.46 (–0.57 to –0.34) IDegLira vs. IDeg P <0.0001 (noninferior)ETD –1.02 (–1.18 to –0.87) IDegLira vs. placebo P <0.001 (superior)ETD 0.12 (–0.04 to 0.28) IDegLira 1WT vs. 2WT P = 0.012 (noninferior)ETD –0.3 (–0.4 to –0.2) iGlarLixi vs. IGlar P <0.0001
ETD –0.65 (–0.76 to –0.53) IDegLira vs. Lira P <0.0001 (superior)ETD –0.8 (–0.9 to –0.7) iGlarLixi vs. Lixi P <0.0001
A1C responders <7.0% (%)IDegLira: 78.2 IDegLira: 62.5 Lira: 56.5 P <0.0001 for all comparisonsIDegLira: 79.2 Placebo: 28.8 P <0.001IDegLira 1WT: 89.9 IDegLira 2WT: 89.5 P = NSiGlarLixi: 73.7 IGlar: 59.4 Lixi: 33.0 P <0.0001 for all comparisons
Change in FPG (mg/dL)IDegLira: –62.1 IDeg: –61.2 Lira: –30.2IDegLira: –46.8 Placebo: –5.6IDegLira 1WT: –78.0 IDegLira 2WT: –81.9iGlarLixi: –62.4 IGlar: –59.0 Lixi: –27.0
ETD –3.6 (–8.1 to 0.90) IDegLira vs. IDeg P = 0.11ETD –41.50 (–48.94 to –34.07) IDegLira vs. placebo P <0.001ETD 3.96 (–2.02 to 9.93) IDegLira 1WT vs 2WT P = 0.194ETD –3.5 (–7.6 to 0.7) iGlarLixi vs. IGlar P = 0.1
ETD –30.1 (–34.6 to –25.6) IDegLira vs. Lira P <0.0001ETD –35.4 (–40.5 to –30.3) iGlarLixi vs. Lixi P <0.0001
  • Values are reported as mean (95% CI).

  • 1WT, once weekly titration; 2WT, twice weekly titration; IDeg, insulin degludec U100; IGlar, insulin glargine U100; Lira, liraglutide 6 mg/mL; Lixi, lixisenatide.