Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient|
- Mean Daily Blood Glucose Levels During Hospital [ Time Frame: Hospital days 2-5 ]mean of average daily blood blood glucose for each patient day
- Percentage of Blood Glucose Readings in 70-140 mg/dL Range [ Time Frame: Days 2 to 5 ]Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.
- Dose of Insulin [ Time Frame: Days 2 to 5 ]Average daily amount of insulin used
- Incidence of Hypoglycemia (BG <70 mg/dL) [ Time Frame: Days 2 to 5 ]Number of BG readings <70 mg/dL in each group
- Incidence of Hyperglycemia (Blood Glucose >200 mg/dL) [ Time Frame: Days 2 to 5 ]Proportion of BG readings in the severe hyperglycemic range.
- Variability in Glucose Levels [ Time Frame: Days 2 to 5 ]Mean amplitude of glycemic excursions
- Length of Hospital Stay [ Time Frame: Admission to discharge, an expected average of 5 days ]Number of days in hospital
- Patient Satisfaction [ Time Frame: 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.
|Study Start Date:||July 2014|
|Study Completion Date:||February 2017|
|Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: Saxagliptin group
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.
2.5-5 mg daily
No Intervention: Standard therapy group
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02182895
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Rajesh K Garg, MD||Brigham and Women's Hospital|