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

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.

Study Overview

• Status: Terminated
• Conditions: Hyperglycemia; Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Sitagliptin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43203
      • The Ohio State University Wexner Medical CEnter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Either of the following: Mild Diabetes Mellitus or Stress Hyperglycemia
• AND:
• Cardiac Surgery
• Insulin Requirement between 8-30 units subcutaneous on post-op day 3 or later off pressors, off enteral feeding, extubated OR glucose >150 mg/dL at least twice in a 24 hour period (>4 hours apart) and otherwise not requiring basal insulin

Exclusion Criteria:

• use of pressors, mechanical ventilation, or enteral or parenteral feeding within previous 12 hours
• glucocorticoids in doses exceeding the equivalent of Prednisone 10 mg/day within the previous 48 hours
• left ventricular assist device
• percutaneous or laparoscopic surgery
• end stage renal disease
• end stage liver disease
• history of pancreatitis
• type 1 diabetes
• pregnancy
• unable to give consent in english
• no phone
• prisoners
• less than 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sitagliptin; Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge	Drug: Sitagliptin; Sitagliptin prior to hospital discharge and 6 weeks following discharge.; Other Names: Januvia
Placebo Comparator: Placebo; Patients will receive placebo prior to discharge and 6 weeks after discharge.	Drug: Placebo; Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Fasting Glucose	Difference in mean fasting glucose at 6 weeks post-discharge.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Monitored Blood Glucose	Mean blood glucose at week 2	2 weeks
Adherence	adherence defined as 80% of all Sitagliptin doses respectively taken in previous week	6 weeks
Hypoglycemia	Number of subjects with glucose <70 mg/dl following time of discharge to 6 weeks.	6 weeks

Collaborators and Investigators

• Sponsor: Kathleen Dungan
• Investigators: Principal Investigator: Kathleen M Dungan, MD, MPH, Ohio State University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 22, 2013
• First Posted (Estimate): October 28, 2013

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 2013H0328