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

This study has been terminated.
(Recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970462
First Posted: October 28, 2013
Last Update Posted: September 27, 2016
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.
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Hyperglycemia Drug: Sitagliptin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Kathleen Dungan, The Ohio State University:

Primary Outcome Measures:
  • Difference in Fasting Glucose [ Time Frame: 6 weeks ]

Other Outcome Measures:
  • Self Monitored Blood Glucose [ Time Frame: 2 and 6 weeks ]
  • Adherence [ Time Frame: 2 and 6 weeks ]
  • Hypoglycemia [ Time Frame: 2 and 6 weeks ]

Enrollment: 8
Study Start Date: January 2014
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01970462


Locations
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43203
Sponsors and Collaborators
Kathleen Dungan
Investigators
Principal Investigator: Kathleen M Dungan, MD, MPH Ohio State University
  More Information

Responsible Party: Kathleen Dungan, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01970462     History of Changes
Other Study ID Numbers: 2013H0328
First Submitted: October 22, 2013
First Posted: October 28, 2013
Last Update Posted: September 27, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action