title: The effects of exenatide twice daily compared to insulin lispro added to basal insulin in Latin American patients with type 2 diabetes: A retrospective analysis of the 4B trial.
abstract: OBJECTIVE
  Socioeconomic changes in Latin American countries have led to an increased prevalence of type 2 diabetes (T2D). We examined the effects of exenatide twice daily (BID) or insulin lispro, each added to insulin glargine, in Latin American patients with T2D.
  
  
  METHODS
  This was a subgroup analysis of patients from Argentina and Mexico in the 4B study (N=114). Patients with glycated hemoglobin (HbA1c) of 7.0-10.0% (53-86mmol/mol) after 12weeks of intensive basal insulin optimization were randomized to exenatide BID or thrice-daily insulin lispro added to insulin glargine and metformin.
  
  
  RESULTS
  After 30weeks, addition of exenatide BID or insulin lispro resulted in significant (P<0.0001) reductions in HbA1c (exenatide BID: -0.9% [-10mmol/mol]; insulin lispro: -1.2% [-13mmol/mol]). Weight was stable in the exenatide BID group (-0.1kg) and increased significantly (+3.4kg; P<0.0001) with insulin lispro. Major and minor hypoglycemia occurred less frequently (40 vs. 253 events) with exenatide BID compared with insulin lispro. Gastrointestinal adverse events of nausea, diarrhea, and vomiting occurred more frequently with exenatide BID than with insulin lispro.
  
  
  CONCLUSIONS
  Both exenatide BID and prandial insulin lispro, each added to basal insulin glargine, were effective at reducing HbA1c in Latin American patients. Treatment with exenatide BID resulted in stable weight but more gastrointestinal adverse events. Treatment with insulin lispro resulted in weight gain and an increased risk of hypoglycemia. These findings support the addition of exenatide BID to insulin glargine as an option for Latin American patients unable to achieve glycemic control on basal insulin alone.
authors: National University of the Northeast, School of Medicine, Corrientes, Argentina.
authors: Silvia Beatriz Gorban
authors: SB
authors: de Lapertosa
authors: Hospital de Clinicas, Universidad de Buenos Aires, Buenos Aires, Argentina. Electronic address: gfrechtel@ffyb.uba.ar.
authors: Gustavo
authors: G
authors: Frechtel
authors: AstraZeneca, Gaithersburg, MD, USA.
authors: Elise
authors: E
authors: Hardy
authors: Instituto de Diabetes Obesidad y Nutrición, Sociedad Civil, Cuernavaca, Mexico.
authors: Leobardo
authors: L
authors: Sauque-Reyna
mesh_terms: D000328:Adult; D000368:Aged; D001118:Argentina; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D000077270:Exenatide; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000009:adverse effects / Q000627:therapeutic use*; D061268:Insulin Lispro / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use; D008800:Mexico; D008875:Middle Aged; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome; D014481:United States; D014688:Venoms / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D061268:Insulin Lispro; D008687:Metformin; D010455:Peptides; D014688:Venoms; C517652:hemoglobin A1c protein, human
keywords: Exenatide; Insulin lispro; Latin America; Type 2 diabetes