Sitagliptin Plus Basal Insulin Comparable to Basal-Bolus Regimen in Type 2 Diabetes

Patients who used a combination therapy of sitagliptin plus basal insulin for type 2 diabetes management had similar hospital length of stay, daily blood glucose concentration levels, and rates of hypoglycemia compared with patients who used a more labor-intensive basal-bolus insulin regimen, according to results from a prospective, randomized clinical trial published in The Lancet Diabetes & Endocrinology.

Francisco J Pasquel, MD, from Emory University in Atlanta, and colleagues randomly assigned 277 patients between August 2013 and July 2015 to receive treatment with once-daily sitagliptin plus basal glargine (n=138) or a once-daily basalt 2013 and July 2015 to receiv and rapid-acting insulin lispro or aspart (n=139) taken before meals. Patients, aged 18 to 80 years, were from 5 different hospitals; had type 2 diabetes; were taking diet or oral antidiabetic drugs; and had a total daily insulin dose of 0.6 units per kg and a random blood glucose concentration of 7.8 to 22.2 mmol/L.

“Guidelines from professional organizations for the management of non-critically ill patients with type 2 diabetes admitted to hospital recommend the use of basal-bolus insulin regimens, which are labor-intensive and associated with a risk of hypoglycemia,” Dr Pasquel and colleagues wrote. “The results of our clinical trial show that treatment with the DPP-4 inhibitor sitagliptin and basal insulin once daily is 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.”

The researchers found both groups had a median length of stay in the hospital of 4 days (P = 0.54), and mean daily blood glucose concentration in the sitagliptin-basal (9.5 mmol/L) group was noninferior to the basal-bolus (9.4 mmol/L) group (mean difference = 0.1 mmol/L; 95% CI, –0.6 to 0.7). The sitagliptin-basal group had a treatment failure rate of 16% (n=22), while the basal-bolus group had a failure rate of 19% (n=17; P =.54). There were also comparable rates of hypoglycemia in the sitagliptin-basal (9%; n = 13) and basal-bolus (12%; n=17) groups (P =.45). The researchers noted there were no significant hospital-based complications between either group, and there were no deaths in the study.

The researchers found both groups had a median length of stay in the hospital of 4 days (P =.54), and mean daily blood glucose concentration in the sitagliptin-basal group (9.5 mmol/L) was noninferior to the basal-bolus group (9.4 mmol/L; mean difference: 0.1 mmol/L; 95% CI, – 0.6 to 0.7).

The sitagliptin-basal group had a treatment failure rate of 16% (n=22), while the basal-bolus group had a failure rate of 19% (n=17; P =.54). There were also comparable rates of hypoglycemia in the sitagliptin-basal (9%; n=13) and basal-bolus (12%; n=17) groups (P =.45). The researchers noted there were no significant hospital-based complications between either group, and there were no deaths in the study.

“Additionally, treatment with sitagliptin and basal insulin required a lower daily insulin dose and fewer insulin injections, representing a safe, effective, and more convenient alternative to the standard basal–bolus insulin regimen, particularly in hospitals and areas of low staffing and resources,” Dr Pasquel and colleagues wrote.

The researchers noted that patients and investigators were not blinded to treatment in the trial, and that they excluded some patients that may have benefited from a basal-bolus treatment regimen, such as hepatic disease or pancreatitis or patients admitted to an intensive care unit. However, they said a sitagliptin-basal approach could be used to treat many patients with type 2 diabetes admitted to a hospital.

“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 researchers wrote.

Disclosures: The study was funded by Merck.

Reference

1. Pasquel FJ, Gianchandani R, Rubin DJ, et al. Efficacy of sitagliptin for the hospital management of general medicine and surgery patients with type 2 diabetes (Sita-Hospital): a multicentre, prospective, open-label, non-inferiority randomised trial [published online December 7, 2016]. Lancet Diabetes Endocrinol. doi:10.1016/S2213-8587(16)30402-8.