Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients.

Publication/Presentation Date

1-1-2017

Abstract

OBJECTIVE: To evaluate whether saxagliptin is non-inferior to basal-bolus insulin therapy for glycemic control in patients with controlled type 2 diabetes mellitus (T2DM) admitted to hospital with non-critical illnesses.

RESEARCH DESIGN AND METHODS: This was an open-label, randomized controlled clinical trial. Patients received either saxagliptin or basal-bolus insulin, both with correctional insulin doses. The main study outcome was the mean daily blood glucose (BG) after the first day of randomization.

RESULTS: Of 66 patients completing the study, 33 (age 69±10 years, 40% men) were randomized to saxagliptin and 33 (age 67±10 years, 52% men) to basal-bolus insulin therapy. The mean daily BG was 149.8±22.0 mg/dL in the saxagliptin group and 146.9±30.5 mg/dL in the insulin group (p=0.59). With an observed group difference of 2.9 mg/dL and an a priori margin of 20 mg/dL, inferiority of saxagliptin was rejected in favor of non-inferiority (p=0.007). There was no significant difference in the percentage of high or low BG values. The insulin group received a higher number of insulin injections (2.3±1.7/day vs 1.2±1.9/day; p

CONCLUSIONS: We conclude that saxagliptin use is non-inferior to basal-bolus insulin in non-critically ill hospitalized patients with T2DM controlled on 0-2 oral agents without insulin. Saxagliptin use may decrease glycemic variability in these patients.

TRIAL REGISTRATION NUMBER: NCT02182895.

Volume

5

Issue

1

First Page

000394

Last Page

000394

ISSN

2052-4897

Disciplines

Medicine and Health Sciences

PubMedID

28405346

Department(s)

Department of Medicine

Document Type

Article

Link to Full Text

Share

COinS