Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2, Hyperglycemia

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sitagliptin

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sitagliptin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Difference in Fasting Glucose

Difference in mean fasting glucose at 6 weeks post-discharge.

Secondary Outcome Measures

Full Information

NCT ID

NCT01970462

First Posted

October 22, 2013

Last Updated

May 16, 2018

Sponsor

Kathleen Dungan

1. Study Identification

Unique Protocol Identification Number

NCT01970462

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

Recruitment

Study Start Date

January 2014 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kathleen Dungan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Hyperglycemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sitagliptin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Other Intervention Name(s)

Januvia

Intervention Description

Sitagliptin prior to hospital discharge and 6 weeks following discharge.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Difference in Fasting Glucose

Description

Difference in mean fasting glucose at 6 weeks post-discharge.

Time Frame

6 weeks

Other Pre-specified Outcome Measures:

Title

Self Monitored Blood Glucose

Description

Mean blood glucose at week 2

Time Frame

2 weeks

Title

Adherence

Description

adherence defined as 80% of all Sitagliptin doses respectively taken in previous week

Time Frame

6 weeks

Title

Hypoglycemia

Description

Number of subjects with glucose <70 mg/dl following time of discharge to 6 weeks.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen M Dungan, MD, MPH

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ohio State University Wexner Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43203

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs