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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02182895
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : June 1, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Saxagliptin Phase 4

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
Study Start Date : July 2014
Primary Completion Date : February 2017
Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Mean Daily Blood Glucose Levels During Hospital [ Time Frame: Hospital days 2-5 ]
    mean of average daily blood blood glucose for each patient day


Secondary Outcome Measures :
  1. Percentage of Blood Glucose Readings in 70-140 mg/dL Range [ Time Frame: Days 2 to 5 ]
    Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.

  2. Dose of Insulin [ Time Frame: Days 2 to 5 ]
    Average daily amount of insulin used

  3. Incidence of Hypoglycemia (BG <70 mg/dL) [ Time Frame: Days 2 to 5 ]
    Number of BG readings <70 mg/dL in each group

  4. Incidence of Hyperglycemia (Blood Glucose >200 mg/dL) [ Time Frame: Days 2 to 5 ]
    Proportion of BG readings in the severe hyperglycemic range.

  5. Variability in Glucose Levels [ Time Frame: Days 2 to 5 ]
    Mean amplitude of glycemic excursions

  6. Length of Hospital Stay [ Time Frame: Admission to discharge, an expected average of 5 days ]
    Number of days in hospital

  7. Patient Satisfaction [ Time Frame: At the time of discharge or Day 5 ]
    Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction.


Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182895


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
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
First Posted: July 8, 2014    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: June 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data.

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