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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01970462
• Other study ID #: 2013H0328
• Status: Terminated
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: May 2018
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia

Intervention

Drug:
• Sitagliptin
Sitagliptin prior to hospital discharge and 6 weeks following discharge.
• Placebo
Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kathleen Dungan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self Monitored Blood Glucose	Mean blood glucose at week 2	2 weeks
Other	Adherence	adherence defined as 80% of all Sitagliptin doses respectively taken in previous week	6 weeks
Other	Hypoglycemia	Number of subjects with glucose <70 mg/dl following time of discharge to 6 weeks.	6 weeks
Primary	Difference in Fasting Glucose	Difference in mean fasting glucose at 6 weeks post-discharge.	6 weeks