Randomized clinical trial of the efficacy and safety of insulin glargine vs. NPH insulin as basal insulin for the treatment of glucocorticoid induced hyperglycemia using continuous glucose monitoring in hospitalized patients with type 2 diabetes and respiratory disease
Abstract
Aims To investigate the clinical efficacy and safety of insulin glargine compared with NPH insulin as basal insulin for the management of corticosteroid-induced hyperglycemia in hospitalized people with type 2 diabetes (T2DM) and respiratory disease.Materials and methods Randomized, two-arm parallel group, clinical trial undertaken from February 2011 to November 2012 on the pneumology ward of the Hospital Regional Universitario de Málaga (Spain), involving 53 participants with T2DM treated with medium/high doses of intermediate-acting corticosteroids. Participants were randomly assigned to receive one single dose of insulin glargine or NPH insulin in three equally divided doses before each meal as basal insulin within a basal-bolus insulin protocol. The intervention lasted six days or until discharge if earlier.Results No significant differences were seen between groups during the study in mean blood glucose (11.43±3.44 mmol/l in glargine vs. 11.88±2.94 mmol/l in NPH, p=0.624), and measures of glucose variability (standard deviation 3.27±1.16 mmol/l vs. 3.61±0.99 mmol/l, p=0.273; coefficient of variation 1.55±0.33 mmol/l vs. 1.72±0.39 mmol/l, p=0.200). Results from CGM were concordant with those obtained with capillary blood glucose reading. The length of hospital stay was also similar between groups (8.2±2.8 days vs. 9.8±3.4 days, p=0.166) There was a non significant trend for lower episodes of mild (4 vs. 8, p=0.351) and severe hypoglycemia (0 vs. 3, p=0.13) in the glargine group.Conclusions The results of this study showed that insulin glargine and NPH insulin are equally effective in a basal-bolus insulin protocol to treat glucocorticoid-induced hyperglycemia in people with T2DM on a pneumology ward.
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Three studies compared BBI regimens with long-acting insulins to BBI regimens with intermediate-acting neutral protamin Hagedorn (NPH) insulin, but in one of these studies, NPH was given in three equal prandial doses.
“Three studies compared BBI regimens with long-acting insulins to BBI regimens with intermediate-acting neutral protamin Hagedorn (NPH) insulin,35 36 39 but in one of these studies, NPH was given in three equal prandial doses.36”
In hospitalised persons with type 2 diabetes mellitus treated with medium-dose to high-dose glucocorticoids, NPH insulin and long-acting insulin glargine as basal insulin in a basal-bolus insulin regimen show similar overall glycaemic control, with no significant differences.
“All three studies show a similar overall glycaemic control for NPH or glargine as basal insulin.35 36 39”
Severe hypoglycaemia (blood glucose level <2.22 mmol/L) occurred in two persons in the NPH group in the study by Ruiz de Adana et al.
“Notably, severe hypoglycaemia (BGL <2.22 mmol/L) occurred in two persons in the NPH group in the study by Ruiz de Adana et al. 36”
Insulin requirement was higher in basal-bolus insulin with long-acting insulin compared with NPH as basal insulin in two studies, but it was similar in the other.
“Insulin requirement, however, was higher in BBI with long-acting insulin compared with NPH as basal insulin in two of the studies,36 39 but it was similar in the other.35”
NPH insulin caused more hypoglycaemic events when NPH and bolus insulin were administered in equal preprandial doses for the purpose of controlling hyperglycaemia in persons receiving multiple daily doses of glucocorticoids.
“However, NPH insulin caused more hypoglycaemic events when NPH and bolus insulin were administered in equal preprandial doses for the purpose of controlling hyperglycaemia in persons receiving multiple daily doses of glucocorticoids.36”
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- Authors
- Ruiz de Adana, M. S., Colomo, N., Maldonado-Araque, C., Fontalba, M. I., Linares, F., García-Torres, F., Fernández, R., Bautista, C., Olveira, G., de la Cruz, J. L., Rojo-Martínez, G., & Valdés, S.
- Affiliations
- Centro de Investigación Biomédica en Red Diabetes y Enfermedades Metabólicas Asociadas (ES)
- Hospital Regional Universitario de Málaga (ES)
- Venue
- Diabetes Research and Clinical Practice
- Publisher
- Elsevier BV
- Published
- 2015-11
- Volume
- 110
- Issue
- 2
- Pages
- 158-165
- ISSN
- 0168-8227 (ISSN-L)
- OpenAlex
- W1785976117
- Cited by
- 45
- References
- 19
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 5 · 2023: 4 · 2022: 10 · 2021: 5 · 2020: 2 · 2019: 4 · 2018: 4 · 2017: 1 · 2016: 2
- FWCI
- 2.02
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Research and Clinical Practice (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hyperglycemia and glycemic control in critically ill and hospitalized patients
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- insulin glargine, NPH insulin, basal insulin, glucocorticoid-induced hyperglycemia, type 2 diabetes, respiratory diseases, continuous glucose monitoring, multiple daily insulin injections, hypoglycemia, glycemic variability, hospitalized patients, corticosteroid-induced diabetes
- MeSH terms
- Insulin Glargine, Adolescent, Adult, Aged, Aged, 80 and over, Blood Glucose, Diabetes Mellitus, Type 2, Drug Administration Schedule, Drug Therapy, Combination, Female, Glucocorticoids, Humans, Hyperglycemia, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin, Isophane, Male, Middle Aged, Respiratory Tract Diseases, Safety, Young Adult
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