Pharmacogenetic studies have shown significant differences among racial and ethnic groups. This post-hoc analysis of 2 30-week phase 3 trials of patients with type 2 diabetes uncontrolled on metformin ± oral antidiabetes drugs (OADs) (LixiLan-O: NCT02058147) or basal insulin ± OADs (LixiLan-L: NCT02058160) determined the safety of iGlarLixi vs. insulin glargine (iGlar) among Hispanic and non-Hispanic patients.
Analysis of variance/covariance was used for continuous variables and χ2/Cochran-Mantel-Haenszel for categorical variables. A generalized linear model using negative binomial distributions with factors of treatment arm and ethnicity, covariates of age and baseline weight or BMI, and log exposure as offset, was used for symptomatic hypoglycemia (plasma glucose ≤70mg/dL) rates. Adjusted hypoglycemia rates used the same model with mean values of age and baseline weight or BMI.
Across studies 20% (353/1730) of all patients were Hispanic. At baseline, Hispanic patients had significantly lower body weight, BMI, and fasting plasma glucose vs. non-Hispanic patients (all, P<0.001). Overall, clinical outcomes were similar for Hispanic and Non-Hispanic patients, regardless of drug type (Figure). However, iGlarLixi demonstrates better glycemic control in both Hispanic and non-Hispanic patients, with similar safety outcomes to iGlar.
P. Mora: Advisory Panel; Self; Novo Nordisk Inc.. Consultant; Self; Sanofi US. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi US. J. Chao: None. A. Saremi: Employee; Self; Sanofi US. T.A. Dex: Employee; Self; Sanofi US. Stock/Shareholder; Self; Pfizer Inc., Merck Sharp & Dohme Corp., Teva Pharmaceutical Industries Ltd.. M. Roberts: None. G.E. Umpierrez: Research Support; Self; Sanofi US, Merck & Co., Inc., Novo Nordisk Inc., AstraZeneca. Advisory Panel; Self; Sanofi, Intarcia Therapeutics, Inc..