Randomized Controlled Trial
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Oct 15, 2017; 8(10): 455-463
Published online Oct 15, 2017. doi: 10.4239/wjd.v8.i10.455
Neutral protamine hagedorn/regular insulin in the treatment of inpatient hyperglycemia: Comparison of 3 basal-bolus regimens
Dania Lizet Quintanilla-Flores, José Gerardo González-González, Guillermo García-De la Cruz, Héctor Eloy Tamez-Pérez
Dania Lizet Quintanilla-Flores, Department of Internal Medicine, “Dr. José Eleuterio González” University Hospital, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León 64460, México
José Gerardo González-González, Endocrinology Service, “Dr. José Eleuterio González” University Hospital, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León 64460, México
Guillermo García-De la Cruz, School of Medicine, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León 64460, México
Héctor Eloy Tamez-Pérez, Research Division, School of Medicine, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León 64460, México
Author contributions: Quintanilla-Flores DL and García-De la Cruz G were involved in conception and design of the study, acquisition of data, analysis and interpretarion of data; Tamez-Pérez HE outlined and coordinated the writing of the paper and added significant contributions to the text; González-González JG provided input in writing the paper and made significant contributions to the text.
Institutional review board statement: The study was reviewed and approved by the University Hospital and School of Medicine Institutional Review Board.
Clinical trial registration statement: This study was registered at clinicalrials.gov. The registration identification number is NCT02758522.
Informed consent statement: All subjects gave their written informed consent prior to study inclusion. All details that might disclose the identity the subjects under study were omitted in the results.
Conflict-of-interest statement: None of the authors have any conflict to disclose.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Héctor Eloy Tamez-Pérez, MD, Professor of Medicine, Research Division, School of Medicine, Universidad Autónoma de Nuevo León, Av. Francisco I. Madero pte. y Av. Gonzalitos s/n, Colonia Mitras Centro, Monterrey, Nuevo León 64460, México. hector.tamezprz@uanl.edu.mx
Telephone: +52-81-83294050-2870
Received: February 1, 2017
Peer-review started: February 7, 2017
First decision: March 28, 2017
Revised: April 15, 2017
Accepted: May 3, 2017
Article in press: May 5, 2017
Published online: October 15, 2017
Processing time: 253 Days and 22.3 Hours
Abstract
AIM

To compare the safety and efficacy or 3 basal-bolus regimens of neutral protamine hagedorn (NPH)/regular insulin in the management of inpatient hyperglycemia.

METHODS

We randomized 105 patients with blood glucose levels between 140 and 400 mg/dL to a basal-bolus regimen of NPH insulin given once (n = 30), twice (n = 40) or three times (n = 35) daily, in addition to pre-meal regular insulin. Major outcomes included were differences in glycemic control, frequency of hypoglycemia and total insulin dose.

RESULTS

NPH insulin given in a once-daily regimen was associated with better glycemic control (58.3%) compared to twice daily (42.4%) and three times daily (48.9) regimens (P = 0.031). The frequency of hypoglycemia was similar between the three groups (2.0%, 0.7% and 1.2%, P = 0.21). The mean insulin dose at discharge was 0.48 ± 0.14 U/kg in the once-daily group compared to 0.69 ± 0.28 in the twice-daily, and 0.65 ± 0.20 in the three times daily regimens (P < 0.001).

CONCLUSION

NPH insulin administered in a once-daily regimen resulted in improvement in glycemic control with similar rates of hypoglycemia compared to a twice-daily and a three times-daily regimen. Further studies are needed to evaluate whether this regimen could be implemented in all hospitalized patients with hyperglycemia.

Keywords: Neutral protamine hagedorn insulin, Hospital hyperglycemia, Basal-bolus regimen, Type 2 diabetes mellitus, Inpatient care units

Core tip: In this parallel randomized clinical trial, we compared various insulin regimes. Administration of one-daily neutral protamine hagedorn (NPH) regimen improved glycemic control with similar rates compared to a twice-daily and a three times daily regimen. Furthermore, the use of NPH insulin in a once-daily regimen is associated with lower requirements as well as lower variability in the insulin dose during follow up.