Advancing Basal Insulin Glargine with Prandial Lixisenatide QD vs Insulin Glulisine QD or TID in T2DM: The GetGoal-Duo2 Evidence-Based Trial (NCT01768559) (#166)
To provide evidence on how to advance Basal Insulin (BI), we explored treatment options in poorly controlled, BI-treated (≥6 mo ± 1–3 OADs) predominantly obese adults with T2DM randomized to Lixisenatide 20 µg QD (LIXI), Insulin Glulisine QD (GLU-1), or GLU TID (GLU-3), all added to Insulin Glargine (IG) ± Metformin, if HbA1c remained >7–9% after a 12-week IG optimization run-in period after stopping other OADs. Co-primary endpoints at 26 weeks were (1) non-inferiority (95% CI upper bound <0.4%) in HbA1c reduction with LIXI vs GLU-1 and (2) for LIXI vs GLU-3, either non-inferiority in HbA1c reduction (2a) OR superiority in body weight change (2b). FPG, PPG, IG dose, AEs, and hypoglycemia were assessed.
Each arm randomized 298 pts (T2DM duration 12 yrs, BI duration 3 yrs, weight 89 kg). All co-primary endpoints were met as LIXI was non-inferior to GLU-1 and GLU-3 for HbA1c reductions and statistically superior to GLU-3 for body weight loss (Table). Documented hypoglycemia was numerically and significantly lower with LIXI than with GLU-1 and GLU-3, respectively.
In conclusion, BI plus LIXI may become a preferred option to advance BI, attaining meaningful glycemic targets with less hypoglycemia and without negative impact on weight vs Prandial Insulin as Basal Plus or Basal Bolus for uncontrolled, BI-treated T2DM.
Study funded by Sanofi.