Diabetes Mellitus Clinical Trial
Official title:
Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
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.
The current professional organization guidelines recommend insulin as the preferred
treatment for hospitalized patients. It is recommended that most critically ill patients
should receive insulin infusion therapy and non-critically ill patients should receive basal
bolus insulin therapy in the hospital.
The study will test the hypothesis that treatment with saxagliptin is non-inferior to
treatment with basal bolus insulin in this group of patients during their hospital stay. The
study will evaluate the effect of saxagliptin, a DPP4 inhibitor, on glycemic control in
non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM)
The primary outcome will be mean daily blood glucose levels during hospital days 2 to 5. The
study is designed to detect a non-inferiority margin of 20% in the saxagliptin group as
compared to the control group
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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