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

This study is registered with ClinicalTrials.gov, number NCT01845831. Findings Between Aug 23, 2013, and July 27, 2015, we recruited 279 patients, and randomly assigned 277 to treatment; 138 to sitagliptin–basal and 139 to basal–bolus. The length of stay in hospital was similar for both groups (median 4 days [IQR 3–8] vs 4 [3–8] days, p=0·54). The mean daily blood glucose concentration in the sitagliptin–basal group (9·5 mmol/L [SD 2·7]) was not inferior to that in the basal–bolus group 9·4 mmol/L [2·7]) with a mean blood glucose difference of 0·1 mmol/L (95% CI −0·6 to 0·7). No deaths occurred in this trial. Treatment failure occurred in 22 patients (16%) in the sitagliptin–basal group versus 26 (19%) in the basal–bolus group (p=0·54). Hypoglycaemia occurred in 13 patients (9%) in the sitagliptin–basal group and in 17 (12%) in the basal–bolus group (p=0·45). No differences in hospital complications were noted between groups. Seven patients (5%) developed acute kidney injury in the sitagliptin–basal group and six (4%) in the basal–bolus group. One patient (0·7%) developed acute pancreatitis (in the basal–bolus group). Interpretation The trial met the non-inferiority threshold for the primary endpoint, because there was no significant difference between groups in mean daily blood glucose concentrations. Treatment with sitagliptin plus basal insulin is as effective and safe as, and a convenient alternative to, the labour-intensive basalâ...
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research