title: Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus.
abstract: OBJECTIVE
  To compare the effects of the neutral protamine Hagedorn (NPH) recombinant human insulin formulations Gansulin and Humulin N® on the glycemic control of patients with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  Prospective, double-blind, randomized, parallel, single-center study of 37 individuals with T2DM treated with NPH insulin formulations. The Tukey-Kramer test for multiple comparisons, the Wilcoxon paired comparison test and the Chi-Square test were used for the statistical analyses. The significance level was set at 5% (p < 0.05).
  
  
  RESULTS
  The NPH insulin formulations Humulin and Gansulin similarly reduced the HbA1c levels observed at the end of the study compared with the values obtained at the beginning of the study. In the Humulin group, the initial HbA1c value of 7.91% was reduced to 6.56% (p < 0.001), whereas in the Gansulin group, the reduction was from 8.18% to 6.65% (p < 0.001). At the end of the study, there was no significant difference between the levels of glycated hemoglobin (p = 0.2410), fasting plasma glucose (FG; p = 0.9257) and bedtime plasma glucose (BG; p = 0.3906) between the two insulin formulations. There was no nt difference in the number of hypoglycemic events between the two insulin formulations, and no severe hyp episodes were recorded.
  
  
  CONCLUSIONS
  This study demonstrated similar glycemic control by NPH insulin Gansulin compared with human insulin Humulin N® in patients with T2DM.
authors.affiliation: Hospital Geral de Goiânia Alberto Rassi, Goiânia, GO, Brasil.
authors.forename: Nelson
authors.initials: N
authors.lastname: Rassi
authors.affiliation: Instituto de Ciências Farmacêuticas (ICF), Goiânia, GO, Brasil.
authors.forename: Sandra Maria Campos Teixeira de
authors.initials: SM
authors.lastname: Moraes
authors.affiliation: Hospital Geral de Goiânia Alberto Rassi, Goiânia, GO, Brasil.
authors.forename: Adriana Ganam
authors.initials: AG
authors.lastname: Alves
authors.affiliation: Instituto de Ciências Farmacêuticas (ICF), Goiânia, GO, Brasil.
authors.forename: Daniela Cunha
authors.initials: DC
authors.lastname: Cavalheiro
authors.affiliation: Instituto de Ciências Farmacêuticas (ICF), Goiânia, GO, Brasil.
authors.forename: Josianny Mesquita
authors.initials: JM
authors.lastname: Moreira
authors.affiliation: Instituto de Ciências Farmacêuticas (ICF), Goiânia, GO, Brasil.
authors.forename: Karini Bruno
authors.initials: KB
authors.lastname: Bellório
authors.affiliation: Instituto de Ciências Farmacêuticas (ICF), Goiânia, GO, Brasil.
authors.forename: Fernanda Cruvinel de
authors.initials: FC
authors.lastname: Abreu
authors.affiliation: Hospital Geral de Goiânia Alberto Rassi, Goiânia, GO, Brasil.
authors.forename: Paulo Roberto Mendonça
authors.initials: PR
authors.lastname: Prata
authors.affiliation: Instituto de Ciências Farmacêuticas (ICF), Goiânia, GO, Brasil.
authors.forename: Leonardo de Souza
authors.initials: Lde S
authors.lastname: Teixeira
authors.affiliation: Universidade Federal de Goiás (UFG), Goiânia, GO, Brasil.
authors.forename: Salvador
authors.initials: S
authors.lastname: Rassi
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D002626:Chemistry, Pharmaceutical; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000191:economics / Q000627:therapeutic use*; D061386:Insulin, Regular, Human / Q000627:therapeutic use; D000068880:Isophane Insulin, Human / Q000191:economics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061386:Insulin, Regular, Human; D000068880:Isophane Insulin, Human; D011993:Recombinant Fusion Proteins; C517652:hemoglobin A1c protein, human