BASAL-BOLUS REGIMEN WITH INSULIN ANALOGUES VERSUS HUMAN INSULIN IN MEDICAL PATIENTS WITH TYPE 2 DIABETES: A RANDOMIZED CONTROLLED TRIAL IN LATIN AMERICA

Endocr Pract. 2015 Jul;21(7):807-13. doi: 10.4158/EP15675.OR. Epub 2015 Jun 29.

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.

Conclusion: 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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Diabetes Mellitus, Type 2 / blood*
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Female
  • Humans
  • Hypoglycemic Agents / administration & dosage*
  • Insulin / administration & dosage
  • Insulin / analogs & derivatives*
  • Insulin / pharmacology
  • Insulin Glargine / administration & dosage*
  • Insulin Glargine / pharmacology
  • Insulin, Regular, Human / administration & dosage*
  • Insulin, Regular, Human / pharmacology
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care*
  • Paraguay

Substances

  • Hypoglycemic Agents
  • Insulin
  • Insulin, Regular, Human
  • Insulin Glargine
  • insulin glulisine