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

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ClinicalTrials.gov Identifier: NCT01970462
Recruitment Status : Terminated (Recruitment)
First Posted : October 28, 2013
Results First Posted : May 17, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Kathleen Dungan, Ohio State University

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Hyperglycemia Drug: Sitagliptin Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Study Start Date : January 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

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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 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




Primary Outcome Measures :
  1. Difference in Fasting Glucose [ Time Frame: 6 weeks ]
    Difference in mean fasting glucose at 6 weeks post-discharge.


Other Outcome Measures:
  1. Self Monitored Blood Glucose [ Time Frame: 2 weeks ]
    Mean blood glucose at week 2

  2. Adherence [ Time Frame: 6 weeks ]
    adherence defined as 80% of all Sitagliptin doses respectively taken in previous week

  3. Hypoglycemia [ Time Frame: 6 weeks ]
    Number of subjects with glucose <70 mg/dl following time of discharge to 6 weeks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Kathleen Dungan, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01970462     History of Changes
Other Study ID Numbers: 2013H0328
First Posted: October 28, 2013    Key Record Dates
Results First Posted: May 17, 2018
Last Update Posted: June 18, 2018
Last Verified: May 2018

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