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

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Saxagliptin

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