Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 70
Inclusion Criteria
- Written informed consent.
- 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.
- 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.
Exclusion Criteria
- Subject unable to give informed consent
- 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.
- ...
- Subject unable to give informed consent
- 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.
- End stage renal disease on dialysis
- Unable to take oral food or medications
- Admitted to or expected to require admission to ICU
- Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors
- History of pancreatitis or active gallbladder disease
- Insulin requiring before admission
- Patients with a history of diabetic ketoacidosis or hyperosmolar state
- HbA1c >7.5% at the time of admission or within 3 months before admission
- Systemic steroid use
Summary
- Conditions
- Diabetes Mellitus
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 110 years
- Gender
- Both males and females
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 hospi...
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
Inclusion Criteria
- Written informed consent.
- 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.
- 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.
Exclusion Criteria
- Subject unable to give informed consent
- 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.
- ...
- Subject unable to give informed consent
- 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.
- End stage renal disease on dialysis
- Unable to take oral food or medications
- Admitted to or expected to require admission to ICU
- Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors
- History of pancreatitis or active gallbladder disease
- Insulin requiring before admission
- Patients with a history of diabetic ketoacidosis or hyperosmolar state
- HbA1c >7.5% at the time of admission or within 3 months before admission
- Systemic steroid use
Tracking Information
- NCT #
- NCT02182895
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Rajesh K Garg, MD Brigham and Women's Hospital
- Rajesh K Garg, MD Brigham and Women's Hospital