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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Saxagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saxagliptin group<br>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. | Drug: Saxagliptin<br>* 2.5-5 mg daily<br>* Other names: DPP4 inhibitor;|
| No Intervention: Standard therapy group<br>Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Daily Blood Glucose Levels During Hospital | mean of average daily blood blood glucose for each patient day | Hospital days 2-5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Blood Glucose Readings in 70-140 mg/dL Range | Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings. | Days 2 to 5 | 
| Dose of Insulin | Average daily amount of insulin used | Days 2 to 5 | 
| Incidence of Hypoglycemia (BG <70 mg/dL) | Number of BG readings <70 mg/dL in each group | Days 2 to 5 | 
| Incidence of Hyperglycemia (Blood Glucose >200 mg/dL) | Proportion of BG readings in the severe hyperglycemic range. | Days 2 to 5 | 
| Variability in Glucose Levels | Mean amplitude of glycemic excursions | Days 2 to 5 | 
| Length of Hospital Stay | Number of days in hospital | Admission to discharge, an expected average of 5 days | 
| Patient Satisfaction | 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. | At the time of discharge or Day 5 |