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

NCT02182895 | Completed Phase 4 Results

• 1 other identifier: 2014P001095
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Mean Daily Blood Glucose Levels During Hospital

  mean of average daily blood blood glucose for each patient day

  Hospital days 2-5

Secondary Outcomes (7)

• Percentage of Blood Glucose Readings in 70-140 mg/dL Range

  Days 2 to 5

• Dose of Insulin

  Days 2 to 5

• Incidence of Hypoglycemia (BG <70 mg/dL)

  Days 2 to 5

• Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)

  Days 2 to 5

• Variability in Glucose Levels

  Days 2 to 5

Study Arms (2)

Saxagliptin group

EXPERIMENTAL

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

Standard therapy group

NO INTERVENTION

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.

Interventions

Saxagliptin DRUG

2.5-5 mg daily

Also known as: Onglyza, DPP4 inhibitor

Saxagliptin group

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Garg R, Schuman B, Hurwitz S, Metzger C, Bhandari S. Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000394. doi: 10.1136/bmjdrc-2017-000394. eCollection 2017.

  PMID: 28405346 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

saxagliptin; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Dr. Rajesh Garg, MD
• Organization: Brigham and Women's Hospital

rgarg@partners.org

617-732-5584

Study Officials

• Rajesh K Garg, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rajesh Garg, MD

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 8, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 23, 2017
• Results First Posted: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)