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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Saxagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02182895

2014P001095

Details and patient eligibility

About

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.

Full 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

Enrollment: 72 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Saxagliptin group

Experimental group

Description:

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.

Treatment:

Drug: Saxagliptin

Standard therapy group

No Intervention group

Description:

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.