Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus

Autor: Salvador Rassi, Daniela Cunha Cavalheiro, Paulo Roberto Mendonça Prata, Nelson Rassi, Josianny Mesquita Moreira, Karini Bruno Bellorio, Leonardo de Souza Teixeira, Fernanda Cruvinel de Abreu, Adriana Ganam Alves, Sandra Maria Campos Teixeira de Moraes
Rok vydání: 2013
Předmět:
Blood Glucose
Male
type 2 diabetes mellitus
Endocrinology
Diabetes and Metabolism
medicine.medical_treatment
Chemistry
Pharmaceutical
lcsh:Medicine
NPH insulin
030204 cardiovascular system & hematology
lcsh:Diseases of the endocrine glands. Clinical endocrinology
chemistry.chemical_compound
0302 clinical medicine
Insulin
Regular
Human
Medicine
Prospective Studies
public health
Middle Aged
Treatment Outcome
Female
Adult
medicine.medical_specialty
Recombinant Fusion Proteins
030209 endocrinology & metabolism
Hypoglycemia
Bedtime
Statistics
Nonparametric
03 medical and health sciences
Double-Blind Method
Internal medicine
Diabetes mellitus
Humans
Hypoglycemic Agents
Glycemic
Glycated Hemoglobin
lcsh:RC648-665
business.industry
Insulin
lcsh:R
Type 2 Diabetes Mellitus
medicine.disease
Isophane Insulin
Human
Endocrinology
chemistry
Diabetes Mellitus
Type 2
glycated hemoglobin A
Glycated hemoglobin
Comparative study
business
Zdroj: Archives of Endocrinology and Metabolism, Volume: 60, Issue: 1, Pages: 47-53, Published: FEB 2016
Archives of Endocrinology and Metabolism v.60 n.1 2016
Arquivos de Endocrinologia e Metabolismo
Sociedade Brasileira de Endocrinologia e Metabologia (SBEM)
instacron:SBEM
Archives of Endocrinology and Metabolism, Vol 60, Iss 1, Pp 47-53
ISSN: 2359-4292
Popis: 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). Subjects and 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. Conclusion This study demonstrated similar glycemic control by NPH insulin Gansulin compared with human insulin Humulin N® in patients with T2DM.
Databáze: OpenAIRE
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