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

NCT ID: NCT01970462

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-08-31

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.

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sitagliptin

Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge

Group Type: EXPERIMENTAL

Sitagliptin

Intervention Type: DRUG

Sitagliptin prior to hospital discharge and 6 weeks following discharge.

Placebo

Patients will receive placebo prior to discharge and 6 weeks after discharge.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Sitagliptin

Sitagliptin prior to hospital discharge and 6 weeks following discharge.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Januvia

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kathleen Dungan

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Dungan

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kathleen M Dungan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2013H0328

Identifier Type: -

Identifier Source: org_study_id