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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Kathleen Dungan, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01970462
First received: October 22, 2013
Last updated: June 12, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Ohio State University:

Primary Outcome Measures:
  • Difference in Fasting Glucose [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Self Monitored Blood Glucose [ Time Frame: 2 and 6 weeks ] [ Designated as safety issue: No ]
  • Adherence [ Time Frame: 2 and 6 weeks ] [ Designated as safety issue: No ]
  • Hypoglycemia [ Time Frame: 2 and 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970462

Contacts
Contact: Kelly E Rogers, MS 6146886885 kelly.rogers@osumc.edu

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43203
Contact: Kelly E Rogers, MS    614-688-6885    kelly.rogers@osumc.edu   
Sponsors and Collaborators
Kathleen Dungan
Investigators
Principal Investigator: Kathleen M Dungan, MD, MPH Ohio State University
  More Information

No publications provided

Responsible Party: Kathleen Dungan, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01970462     History of Changes
Other Study ID Numbers: 2013H0328
Study First Received: October 22, 2013
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014