title: BASAL-BOLUS REGIMEN WITH INSULIN ANALOGUES VERSUS HUMAN INSULIN IN MEDICAL PATIENTS WITH TYPE 2 DIABETES: A RANDOMIZED CONTROLLED TRIAL IN LATIN AMERICA.
abstract: OBJECTIVE
  Few randomized studies have focused on the optimal management of non-intensive care unit patients with type 2 diabetes in Latin America. We compared the safety and efficacy of a basal-bolus regimen with analogues and human insulins in general medicine patients admitted to a University Hospital in Asunción, Paraguay.
  
  
  METHODS
  In a prospective, open-label trial, we randomized 134 nonsurgical patients with blood glucose (BG) between 140 and 400 mg/dL to a basal-bolus regimen with glargine once daily and glulisine before meals (n = 66) or Neutral Protamine Hagedorn (NPH) twice daily and regular insulin before meals (n = 68). Major outcomes included differences in daily BG levels and frequency of hypoglycemic events between treatment groups.
  
  
  RESULTS
  There were no differences in the mean daily BG (157 ± 37 mg/dL versus 158 ± 44 mg/dL; P = .90) or in the number of BG readings within target <140 mg/dL before meals (76% versus 74%) between the glargine/glulisine and NPH/regular regimens. The mean insulin dose in the glargine/glulisine group was 0.76 ± 0.3 units/kg/day (glargine, 22 ± 9 units/day; glulisine, 31 ± 12 units/day) and was not different compared with NPH/regular group (0.75 ± 0.3 units/kg/day [NPH, 28 ± 12 units/day; regular, 23 ± 9 units/day]). The overall prevalence of hypoglycemia (<70 mg/dL) was similar between patients treated with NPH/regular and glargine/glulisine (38% versus 35%; P = .68), but more patients treated with human insulin had severe (<40 mg/dL) hypoglycemia (7.6% versus 25%; P = .08). There were no differences in length of hospital stay or mortality between groups.
  
  
  CONCLUSIONS
  The basal-bolus regimen with insulin analogues resulted in equivalent glycemic control and frequency of hypoglycemia compared to treatment with human insulin in hospitalized patients with diabetes.
authors.forename: Elvio
authors.initials: E
authors.lastname: Bueno
authors.forename: Aldo
authors.initials: A
authors.lastname: Benitez
authors.forename: Jazmín Vera
authors.initials: JV
authors.lastname: Rufinelli
authors.forename: Rafael
authors.initials: R
authors.lastname: Figueredo
authors.forename: Shirley
authors.initials: S
authors.lastname: Alsina
authors.forename: Aldo
authors.initials: A
authors.lastname: Ojeda
authors.forename: Sandra
authors.initials: S
authors.lastname: Samudio
authors.forename: Mirta
authors.initials: M
authors.lastname: Cáceres
authors.forename: Rocío
authors.initials: R
authors.lastname: Argüello
authors.forename: Fabiola
authors.initials: F
authors.lastname: Romero
authors.forename: Gloria
authors.initials: G
authors.lastname: Echagüe
authors.forename: Francisco
authors.initials: F
authors.lastname: Pasquel
authors.forename: Guillermo E
authors.initials: GE
authors.lastname: Umpierrez
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D000069036:Insulin Glargine / Q000008:administration & dosage* / Q000494:pharmacology; D061386:Insulin, Regular, Human / Q000008:administration & dosage* / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010239:Paraguay
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D061386:Insulin, Regular, Human; D000069036:Insulin Glargine; C479079:insulin glulisine