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Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery

NCT01970462 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-06-18

Study results available
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Summary

This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will receive Sitagliptin or placebo. Sitagliptin may be of particular use in this patient population due to the effects on hepatic glucose production (a major feature of SH), safety (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and tolerability. The secondary objective of this study is to determine whether the management of patients with persistent insulin requirements following cardiac surgery differs among patients with stress hyperglycemia or mild diabetes.

Conditions

Interventions

DRUG

Sitagliptin

Sitagliptin prior to hospital discharge and 6 weeks following discharge.

DRUG

Placebo

Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively

Sponsors & Collaborators

  • Kathleen Dungan

    lead OTHER

Principal Investigators

  • Kathleen M Dungan, MD, MPH · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970462 on ClinicalTrials.gov