title: Insulin lispro low mixture twice daily vs basal insulin glargine once daily and prandial insulin lispro once daily as insulin intensification strategies in patients with type 2 diabetes: Latin American subpopulation analysis of a randomized trial.
abstract: BACKGROUND
  This post hoc analysis examined the efficacy and safety of twice-daily insulin lispro low mixture (LM25) and once-daily basal insulin glargine plus once-daily prandial insulin lispro (IGL) in a Latin American subpopulation with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  A phase 4, randomized, open-label, parallel-arm trial included participants aged 18-75 years with T2DM taking once-daily insulin glargine and stable doses of metformin and/or pioglitazone with glycated hemoglobin (HbA1c) 7.5-10.5 % and fasting plasma glucose ≤121 mg/dL. Participants were randomized 1:1 to receive their stable dose of metformin and/or pioglitazone plus twice-daily LM25 or IGL for 24 weeks. The primary efficacy outcome was change in HbA1c after 24 weeks of treatment. Results from participants in Argentina, Brazil, and Mexico are presented here.
  
  
  RESULTS
  162 participants (80 LM25; 82 IGL) with mean ± standard deviation (SD) age = 57.3 ± 9.0 years and body mass index = 31.3 ± 5.2 kg/m(2) were included. Mean ± SD change in HbA1c from baseline to week 24 was -1.5 ± 1.0 % (LM25) and -1.1 ± 1.2 % (IGL). At week 24, 35.1 % (LM25) and 31.6 % (IGL) of participants achieved HbA1c <7.0 %. Mean ± SD weight gain from baseline to week 24 was 2.4 ± 2.9 kg in the LM25 group and 1.0 ± 3.1 kg in the IGL group. The mean ± SD rates of total hypoglycemia per year were 18.9 ± 27.3 (LM25) and 21.6 ± 31.1 (IGL). Rates of treatment-emergent adverse events were 46 % (LM25) and 39 % (IGL).
  
  
  CONCLUSIONS
  Our results suggest that both LM25 and IGL are viable treatment options for insulin intensification in Latin American patients with T2DM with suboptimal glycemic control on basal insulin glargine. The safety and tolerability profiles of LM25 and IGL are consistent between this Latin American population and the global trial-level population. Trial registration NCT01175824.
authors.affiliation: Direccion-investigacion, Servicio Medico Nutricional S.C. (Centro de Diabetes de Coatzacoalcos), Revolucion # 522, 96400 Coatzacoalcos, VER México.
authors.forename: Arturo
authors.initials: A
authors.lastname: Rojas
authors.affiliation: Diabetes and Metabolism Research Department, Head en Instituto de Investigaciones Clínicas, Mar del Plata, Argentina.
authors.forename: Georgina
authors.initials: G
authors.lastname: Sposetti
authors.affiliation: Centro de Pesquisas em Diabetes, Porto Alegre, Rio Grande do Sul Brazil.
authors.forename: Jorge L
authors.initials: JL
authors.lastname: Gross
authors.affiliation: Eli Lilly do Brasil Ltda, São Paulo, Brazil.
authors.forename: Douglas Eugenio
authors.initials: DE
authors.lastname: Barbieri
authors.affiliation: Eli Lilly, Indianapolis, USA.
authors.forename: Ran
authors.initials: R
authors.lastname: Duan
authors.affiliation: Eli Lilly Interamerica Inc., Buenos Aires, Argentina.
authors.forename: Bruno
authors.initials: B
authors.lastname: Linetzky
authors.affiliation: Eli Lilly do Brasil Ltda, São Paulo, Brazil.
authors.forename: Janaina Martins
authors.initials: JM
authors.lastname: De Lana
authors.affiliation: Eli Lilly and Co, México City, México.
authors.forename: Oded
authors.initials: O
authors.lastname: Stempa
authors.affiliation: Lilly Spain, Alcobendas, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Rodriguez
keywords: Diabetes mellitus, type 2; Insulin intensification; Insulin lispro; Insulin lispro mixture; Latin America