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

Completed · Phase 4

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02182895

Run by

Brigham and Women's Hospital

People needed

72

Starts

2014-07-01

Expected to finish

2017-02-01

Last updated by the study team

2017-06-23

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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