A Randomized Controlled Trial on the Safety and Efficacy of Exenatide Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes

Abstract

Objective: This multicenter, open-label, randomized trial examined the safety and efficacy of exenatide alone or in combination with basal insulin in non-critically ill patients with type 2 diabetes (T2D).

Research design and methods: A total of 150 patients with blood glucose (BG) between 140 and 400 mg/dL, treated at home with diet, oral agents, or insulin at a total daily dose <0.5 units/kg, were randomized to exenatide alone (5 μg twice daily), exenatide plus basal insulin, or a basal-bolus insulin regimen. The primary end point was difference in mean daily BG concentration among groups.

Results: Mean daily BG was similar between patients treated with exenatide plus basal and a basal-bolus regimen (154 ± 39 vs. 166 ± 40 mg/dL, P = 0.31), and exenatide plus basal resulted in lower daily BG than did exenatide alone (177 ± 41 mg/dL, P = 0.02). Exenatide plus basal resulted in a higher proportion of BG levels in target range between 70 and 180 mg/dL compared with exenatide and basal-bolus (78% vs. 62% vs. 63%, respectively, P = 0.023). More patients in the exenatide and exenatide plus basal groups experienced nausea or vomiting than in the basal-bolus group (10% vs. 11% vs. 2%, P = 0.17), with three patients (6%) discontinued exenatide owing to adverse events. There were no differences in hypoglycemia <54 mg/dL (2% vs. 0% vs. 4%, P = 0.77) or length of stay (5 vs. 4 vs. 4 days, P = 0.23) among basal plus exenatide, exenatide, and basal-bolus groups.

Conclusions: The results of this pilot study indicate that exenatide alone or in combination with basal insulin is safe and effective for the management of hospitalized general medical and surgical patients with T2D.

Trial registration: ClinicalTrials.gov NCT02455076.

Figure 1

Randomization scheme. Three subjects were withdrawn owing to HbA_1c being <6.5% (48 mmol/mol) prior to removal of HbA_1c cutoff from the inclusion criteria. Patients who did not receive any study drug were excluded from per-protocol analysis.

Figure 2

A: Mean hospital BG with direct comparison of each treatment group: multiple comparisons done using post hoc Tukey test. Difference in means between exenatide alone and basal bolus: 11 mg/dL (P = 0.39). Difference in means between exenatide alone and exenatide plus basal: 23 mg/dL (P = 0.02). Difference in means between basal bolus and exenatide plus basal: 12 mg/dL (0.31). NS, not significant (P > 0.05). B: Hospital BG within target range 70–180 mg/dL. Differences in number of BGs within target of 70–180 mg/dL reported as percentage of all BG readings. Multiple comparisons of each pair were performed using Wilcoxon tests. C: Daily mean hospital BG. Significant differences in treatment groups: *P = 0.01; †P ≤ 0.05. Exe, exenatide; N, number of patients.