drugset / Trial / NCT02182895

Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient

NCT02182895 ↗

Phase 4 Completed 72 enrolled Brigham and Women's Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this research study is to test the safety and efficacy of a drug called saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c ≤7.0% on ≤ 2 non-insulin agents at home.

Timeline

Start
2014-07
Primary completion
2017-02
Completion
2017-02

Outcome

Met primary endpoint

paper 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) PMID 28405346 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject SAXAGLIPTIN ANHYDROUS Small molecule 2.5 mg —
Subject SAXAGLIPTIN ANHYDROUS Small molecule 5 mg —