Phase 4 Completed N=72 Randomized Treatment

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

Diabetes

Source: ClinicalTrials.gov NCT02182895 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcomePrimary: Mean Daily Blood Glucose Levels During Hospital — 154.8; 156.0 mg/dL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Daily Blood Glucose Levels During Hospital	154.8; 156.0	—
SECONDARY Percentage of Blood Glucose Readings in 70-140 mg/dL Range	42; 37	—
SECONDARY Dose of Insulin	2.4; 13.3	—
SECONDARY Incidence of Hypoglycemia (BG <70 mg/dL)	1; 1	—
SECONDARY Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)	6; 10	—
SECONDARY Variability in Glucose Levels	2.72; 3.93	—
SECONDARY Length of Hospital Stay	8.0; 6.4	—
SECONDARY Patient Satisfaction	70; 75	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02182895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.