Introduction: The SoliMix trial (EudraCT: 2017-003370-13) found better HbA1c with weight benefit and lower hypoglycemia risk for iGlarLixi vs. premix BIAsp 30 in people with type 2 diabetes advancing from basal insulin plus oral antihyperglycemic drugs. This exploratory analysis investigated whether hypoglycemia influenced insulin titration and achievement of fasting plasma glucose (FPG) targets with each therapeutic option.
Methods: Total insulin dose changes from baseline to Week 12 were stratified by hypoglycemia (yes/no) in each treatment arm and ADA Level 2 hypoglycemia (<54 mg/dL [<3.0 mmol/L]) event rates during Weeks 0-12 were modeled according to FPG at Week 12 (when most insulin titration occurred) .
Results: Lesser insulin dose increases occurred in both treatment groups for those who experienced hypoglycemia (mean ± SD iGlarLixi: 3.9 ± 12.5 U; BIAsp 30: 11.0 ± 18.8 U) vs. those who did not (mean ± SD iGlarLixi: 11.2 ± 9.9 U; BIAsp 30: 19.4 ± 19.3 U) . While higher FPG at Week 12 correlated with greater event rates of hypoglycemia in both treatment arms, event rates were higher for BIAsp 30 than for iGlarLixi irrespective of FPG (Figure) .
Conclusions: More frequent hypoglycemia with premix BIAsp 30 than with iGlarLixi may result in lower insulin doses, thus hampering insulin titration and resulting in higher FPG.
F.Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk, Consultant; Lilly Diabetes, Sanofi, Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. J.Rosenstock: Consultant; AstraZeneca, Other Relationship; Applied Therapeutics, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Hanmi Pharm. Co., Ltd., Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Sanofi, Zealand Pharma A/S, Research Support; Genentech, Inc., Merck & Co., Inc., Metacrine, Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., vTv Therapeutics. R.Ritzel: Consultant; Novo Nordisk, Sanofi, Speaker's Bureau; AstraZeneca, Lilly, Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi. O.Deyneli: Advisory Panel; Abbott Diabetes, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Diagnostics, Sanofi, Speaker's Bureau; Abbott, AstraZeneca, Berlin-Chemie AG, Bilim Ilaç, Boehringer Ingelheim International GmbH, Medtronic, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk, Roche Diabetes Care, Sanofi. A.Alvarez: Employee; Sanofi. E.Souhami: Employee; Sanofi, Stock/Shareholder; Sanofi. L.Melas-melt: None. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune.