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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02182895
• Other study ID #: 2014P001095
• Status: Recruiting
• Phase: Phase 4
• First received: June 30, 2014
• Last updated: February 8, 2016
• Start date: July 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: Brigham and Women's Hospital
• Contact: Brooke Schuman
• Phone: 617-732-6870
• Email: bschuman[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 110 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Saxagliptin
2.5-5 mg daily

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean daily blood glucose levels during hospital		Hospital days 2-5	No
Secondary	Mean daily blood glucose levels during hospital		Days 2 to discharge, an expected average of 5 days	No
Secondary	Number of blood glucose readings in 70-140 mg/dL range		Days 2 to 5	No
Secondary	Total dose and number of insulin injections		Days 2 to 5	No
Secondary	Incidence of hypoglycemia (blood glucose <70 mg/dL)		Days 2 to 5	Yes
Secondary	Incidence of hyperglycemia (blood glucose >200 mg/dL)		Days 2 to 5	Yes
Secondary	Variability in glucose levels	Glycemic Lability Index, mean amplitude of glycemic excursions and standard deviation will be used to measure variability in glucose levels	Days 2 to 5	No
Secondary	Length of hospital stay		Admission to discharge, an expected average of 5 days	No
Secondary	Hospital complications	Complications include unexpected events like infections, need for additional surgery and transfer to ICU	Admission to discharge, an expected average of 5 days	No
Secondary	Patient satisfaction	Inpatient diabetes treatment satisfaction questionnaire (DTSQ-IP) will be used for this purpose	Admission to discharge, an expected average of 5 days	No
Secondary	Cost of Hospital Stay	This will include the amount billed to insurance	admission to discharge, an expected average of 5 days	No
Secondary	Requirement for discontinuation of DPP4 inhibitor		Hospital day 2-5	No
Secondary	Incidence of severe hypoglycemia (blood glucose <50 mg/dL)		Hospital day 2-5	Yes