Clinical trial NCT02182895: Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
Official title: Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Mean Daily Blood Glucose Levels During Hospital
timeFrame: Hospital days 2-5
Secondary outcomes:
measure: Percentage of Blood Glucose Readings in 70-140 mg/dL Range
timeFrame: Days 2 to 5
measure: Dose of Insulin
timeFrame: Days 2 to 5
measure: Incidence of Hypoglycemia (BG <70 mg/dL)
timeFrame: Days 2 to 5
measure: Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)
timeFrame: Days 2 to 5
measure: Variability in Glucose Levels
timeFrame: Days 2 to 5
measure: Length of Hospital Stay
timeFrame: Admission to discharge, an expected average of 5 days
measure: Patient Satisfaction
timeFrame: At the time of discharge or Day 5
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Rajesh K Garg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garg R, Schuman B, Hurwitz S, Metzger C, Bhandari S. Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000394. doi: 10.1136/bmjdrc-2017-000394. eCollection 2017.