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

Phase 4

Completed

Brief 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.

Detailed Description: 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

Recruitment & Eligibility

Inclusion Criteria

Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C ≤7.0% on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical illness.
Written informed consent.

Exclusion Criteria

Admitted to or expected to require admission to ICU
Patients with a history of diabetic ketoacidosis or hyperosmolar state
HbA1c >7.5% at the time of admission or within 3 months before admission
Insulin requiring before admission
Unable to take oral food or medications
Systemic steroid use
Pregnancy or breastfeeding
Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
History of pancreatitis or active gallbladder disease
End stage renal disease on dialysis
Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors
Subject unable to give informed consent

Arm && Interventions

Group	Intervention	Description
Saxagliptin group	Saxagliptin	DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime.

Primary Outcome Measures

Name	Time	Method
Mean Daily Blood Glucose Levels During Hospital	Hospital days 2-5	mean of average daily blood blood glucose for each patient day

Secondary Outcome Measures

Name	Time	Method
Percentage of Blood Glucose Readings in 70-140 mg/dL Range	Days 2 to 5	Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.
Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)	Days 2 to 5	Proportion of BG readings in the severe hyperglycemic range.
Length of Hospital Stay	Admission to discharge, an expected average of 5 days	Number of days in hospital
Incidence of Hypoglycemia (BG <70 mg/dL)	Days 2 to 5	Number of BG readings \<70 mg/dL in each group
Variability in Glucose Levels	Days 2 to 5	Mean amplitude of glycemic excursions
Dose of Insulin	Days 2 to 5	Average daily amount of insulin used
Patient Satisfaction	At the time of discharge or Day 5	Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction.