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

NCT01970462 | Terminated Phase 4 Results

• 1 other identifier: 2013H0328
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Difference in Fasting Glucose

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

  6 weeks

Other Outcomes (3)

• Self Monitored Blood Glucose

  2 weeks

• Adherence

  6 weeks

• Hypoglycemia

  6 weeks

Study Arms (2)

Sitagliptin

EXPERIMENTAL

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

Drug: Sitagliptin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sitagliptin DRUG

Sitagliptin prior to hospital discharge and 6 weeks following discharge.

Also known as: Januvia

Sitagliptin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathleen Dungan: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43203, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Kathleen Dungan
• Organization: Ohio State University

kathleen.dungan@osumc.edu

614-685-3333

Study Officials

• Kathleen M Dungan, MD, MPH

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 28, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 18, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-05

Locations

US (1)