Recruitment

Recruitment Status
Completed
Estimated Enrollment
70

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.
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

Patients with a history of diabetic ketoacidosis or hyperosmolar state
Systemic steroid use
End stage renal disease on dialysis
...
Patients with a history of diabetic ketoacidosis or hyperosmolar state
Systemic steroid use
End stage renal disease on dialysis
Unable to take oral food or medications
Insulin requiring before admission
Subject unable to give informed consent
Pregnancy or breastfeeding
Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors
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.
HbA1c >7.5% at the time of admission or within 3 months before admission
Admitted to or expected to require admission to ICU
History of pancreatitis or active gallbladder disease

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

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.
Written informed consent.

Exclusion Criteria

Patients with a history of diabetic ketoacidosis or hyperosmolar state
Systemic steroid use
End stage renal disease on dialysis
...
Patients with a history of diabetic ketoacidosis or hyperosmolar state
Systemic steroid use
End stage renal disease on dialysis
Unable to take oral food or medications
Insulin requiring before admission
Subject unable to give informed consent
Pregnancy or breastfeeding
Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors
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.
HbA1c >7.5% at the time of admission or within 3 months before admission
Admitted to or expected to require admission to ICU
History of pancreatitis or active gallbladder disease

Locations

Boston, Massachusetts, 02115
Boston, Massachusetts, 02115

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