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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Rajesh K. Garg, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT02182895
First received: June 30, 2014
Last updated: February 8, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus
Drug: Saxagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Mean daily blood glucose levels during hospital [ Time Frame: Hospital days 2-5 ]

Secondary Outcome Measures:
  • Mean daily blood glucose levels during hospital [ Time Frame: Days 2 to discharge, an expected average of 5 days ]
  • Number of blood glucose readings in 70-140 mg/dL range [ Time Frame: Days 2 to 5 ]
  • Total dose and number of insulin injections [ Time Frame: Days 2 to 5 ]
  • Incidence of hypoglycemia (blood glucose <70 mg/dL) [ Time Frame: Days 2 to 5 ]
  • Incidence of hyperglycemia (blood glucose >200 mg/dL) [ Time Frame: Days 2 to 5 ]
  • Variability in glucose levels [ Time Frame: Days 2 to 5 ]
    Glycemic Lability Index, mean amplitude of glycemic excursions and standard deviation will be used to measure variability in glucose levels

  • Length of hospital stay [ Time Frame: Admission to discharge, an expected average of 5 days ]
  • Hospital complications [ Time Frame: Admission to discharge, an expected average of 5 days ]
    Complications include unexpected events like infections, need for additional surgery and transfer to ICU

  • Patient satisfaction [ Time Frame: Admission to discharge, an expected average of 5 days ]
    Inpatient diabetes treatment satisfaction questionnaire (DTSQ-IP) will be used for this purpose

  • Cost of Hospital Stay [ Time Frame: admission to discharge, an expected average of 5 days ]
    This will include the amount billed to insurance

  • Requirement for discontinuation of DPP4 inhibitor [ Time Frame: Hospital day 2-5 ]
  • Incidence of severe hypoglycemia (blood glucose <50 mg/dL) [ Time Frame: Hospital day 2-5 ]

Estimated Enrollment: 70
Study Start Date: July 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saxagliptin group
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.
Drug: Saxagliptin
2.5-5 mg daily
Other Names:
  • Onglyza
  • DPP4 inhibitor
No Intervention: Standard therapy group
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.

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02182895

Contacts
Contact: Brooke Schuman 617-732-6870 bschuman@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kyle Carbone    617-732-8311      
Principal Investigator: Rajesh K Garg, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Rajesh K Garg, MD Brigham and Women's Hospital
  More Information

Responsible Party: Rajesh K. Garg, Rajesh Garg, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02182895     History of Changes
Other Study ID Numbers: 2014P001095
Study First Received: June 30, 2014
Last Updated: February 8, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dipeptidyl-Peptidase IV Inhibitors
Saxagliptin
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 28, 2017