December 14, 2016
By Megan Brooks
NEW YORK (Reuters Health) - Sitagliptin plus basal insulin may offer a convenient, less labor-intensive alternative to a basal-bolus insulin regimen for managing diabetes in hospitalized patients, according to results of the Sita-Hospital study.
The sitagliptin plus basal insulin regimen was as effective and safe as basal-bolus insulin in the study of type 2 diabetes patients admitted to general medical and surgery wards.
"We believe that the combination of one daily tablet of sitagliptin and one injection of basal insulin is easier to implement than the multidose insulin injection regimen," Dr. Guillermo Umpierrez from Emory University in Atlanta told Reuters Health by email.
The study appeared online December 7 in the Lancet Diabetes & Endocrinology.
Guidelines for managing hospitalized non-critically ill patients with type 2 diabetes recommend the use of basal-bolus insulin regimens, which are labor-intensive and associated with a risk of hypoglycemia, the authors note.
In the Sita-Hospital clinical trial, treatment with the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin and basal insulin once daily was "similarly efficacious and safe compared to multidose regimens with basal insulin once daily and rapid-acting insulin before meals in patients in hospital with uncontrolled glucose concentrations," they report.
In addition, the sitagliptin-basal insulin regimen was associated with lower daily insulin needs and fewer insulin injections.
The study was a multicenter, prospective non-inferiority randomized trial comparing the traditional basel-bolus approach (insulin glargine plus rapid-acting insulin lispro or aspart) against a combination of glargine and a single daily sitagliptin pill in 277 diabetes patients admitted to general medical or surgery wards in five U.S. hospitals.
The sitagliptin-insulin glargine combination proved as effective as the traditional approach at controlling blood glucose (9.5 vs 9.4 mmol/L; mean difference of 0.1 mmol/L), the investigators report.
"We noted a rapid improvement in glycemic control in both groups, without differences in mean daily blood glucose, number of blood glucose values within target, number of hypoglycemic events, or hospital complications," they write.
The sitagliptin/insulin glargine regimen also resulted in "significant lower daily insulin doses and less number of insulin injections, compared to the basal bolus approach," Dr. Umpierrez told Reuters Health.
"Patients with type 2 diabetes who may benefit from (this) combination are those with moderate degrees of hyperglycemia, patients with a daily total insulin requirement lower than 0.6 units/kg/day, and elderly or frail patients at high risk of hypoglycemia," he added.
"This treatment strategy represents a major advance in the care of general medicine and surgery patients with type 2 diabetes, providing a new therapeutic option for most patients with diabetes in non-intensive-care unit settings," the authors conclude in their paper.
In a linked commentary, Drs. Michael Nauck and Juris Meier of the Division of Diabetology, St. Josef-Hospital, Bochum, Germany say this study "might represent a landmark for the management of in-hospital hyperglycemia; but future trials are needed to delineate more precise pathways for individualized care in this setting. Certainly, results from high-quality randomized trials will help to harmonize widely varying approaches to in-hospital glycemic control between different regions of the world."
The study was funded by Merck. Several authors reported financial relationships with the company and other pharmaceutical companies.
SOURCE: http://bit.ly/2hvBF2S and http://bit.ly/2h0nS3R
Lancet Diabetes Endocrinol 2016.
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