TABLE 1.

Comparison of Randomized, Controlled 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)
Patientsn = 1,663 Type 2 diabetes Insulin-naiven = 435 Type 2 diabetes Insulin-naiven = 420 Type 2 diabetes Insulin-naiven = 1,170 Type 2 diabetes Insulin-naive
Screening criteria
Oral agents at screeningMet ± PioSU ± MetMet ± PioMet ± SU, glinide, DPP-4 inhibitor, or SGLT2 inhibitor
A1C (%)7.0–10.07.0–9.07.5–10.0† or 7.0–9.07.5–10.0 (metformin only) 7.0–9.0 (metformin + other oral agent)
BMI (kg/m2)≤40≤40≤40Not specified
FPG (mg/dL)N/AN/AN/A≤250
Comparison treatmentsIDegLira + Met ± Pio IDeg + Met ± Pio Lira + Met ± PioIDegLira + SU ± Met Placebo + SU ± MetIDegLira 1WT + Met ± Pio IDegLira 2WT + Met ± PioiGlarLixi + Met IGlar + Met Lixi + Met
BlindingOpen-labelDouble-blindedOpen-labelOpen-label
Duration (weeks)26 main phase + 26 extension263230
Run-in period before randomizationNoneNoneNone4 weeks
Baseline characteristics*
Age (years)54.9–55.159.4–60.056.6–57.058.2–58.7
A1C (%)8.37.98.1–8.28.1
BMI (kg/m2)31.2–31.331.2–32.032.4–32.531.6–32.0
Duration of diabetes (years)6.6–7.29.0–9.37.2–7.48.7–8.9
Completers (n [%])IDegLira: 621 (74.5) IDeg: 305 (73.7) Lira: 285 (68.7)IDegLira: 251 (86.9) Placebo: 111 (76.0)IDegLira 1WT: 191 (91.0) IDegLira 2WT: 204 (97.1)iGlarLixi: 440 (93.8) IGlar: 440 (94.2) Lixi: 205 (87.6)
  • * Range of mean values across treatment groups. †For patients treated with just metformin.

  • For patients treated with metformin plus another eligible glucose- lowering therapy.

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