Clinical trial NCT02556918: Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery
Official title: Sitagliptin for the Prevention and Treatment of Hyperglycemia in Patients With Type 2 Diabetes Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperglycemia
Keywords: Coronary artery bypass graft surgery (CABG)
Type 2 Diabetes
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to determine whether treatment with sitagliptin is effective in maintaining blood sugar control in patients with type 2 diabetes (T2D).

Detailed description: The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) and the need for continuous intravenous insulin infusion (CII) in the intensive care unit (ICU) in patients with type 2 diabetes (T2D) undergoing coronary artery bypass graft (CABG) surgery. In addition, the study seeks to determine whether treatment with sitagliptin is effective in maintaining glycemic control and in preventing the need for subcutaneous (SC) insulin therapy in patients with T2D during the transition from intensive care unit (ICU) to regular floor in cardiac surgery patients with T2D.

Eligibility criteria: Inclusion Criteria:

* The ability to provide informed consent
* Ages 18 to 80 years old
* Male or female
* Scheduled to undergo cardiac surgery
* Type 2 Diabetes treated with diet, oral agents,

Exclusion Criteria:

* Severely impaired kidney function (glomeruler filtration rate (GFR ) less than 30 ml/min)
* Clinically significant liver failure
* Imminent risk of death (brain death or cardiac standstill)
* Gastrointestinal obstruction or adynamic ileus
* Expected to require gastrointestinal suction
* Clinically relevant pancreatic or gallbladder disease
* Using oral or injectable corticosteroid
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Female subjects are pregnant or breast feeding at time of enrollment into the study

Primary outcomes:
measure: Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU)
timeFrame: 2 days (average time of discharge from ICU)
measure: Number of Patients With Persistent Hyperglycemia
timeFrame: 10 days (average time of discharge from the hospital)
Secondary outcomes:
measure: Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII)
timeFrame: 2 days (average time of discharge from ICU)
measure: Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)
timeFrame: 2 days (average time of discharge from ICU)
measure: Total IV Insulin in ICU
timeFrame: 2 days (average time of discharge from ICU)
measure: Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery
timeFrame: 2 days (average time of discharge from ICU)
measure: Duration of Continuous Intravenous Insulin Infusion (CII)
timeFrame: Up to 48 hours (average time of discharge from ICU)
measure: Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)
timeFrame: 10 days (average time of discharge from the hospital)
measure: Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)
timeFrame: Up to 14 days (time of discharge from the hospital)
measure: Mean Post-operative Blood Glucose (BG) Concentration
timeFrame: 10 days (average time of discharge from the hospital)
measure: Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)
timeFrame: 2 days (average time of discharge from ICU)
measure: Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours
timeFrame: 48 hours during recovery period
measure: Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU)
timeFrame: 2 days (average time of discharge from ICU)
measure: Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU
timeFrame: 10 days (average time of discharge from the hospital)
measure: Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU)
timeFrame: 2 days (average time of discharge from ICU)
measure: Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU)
timeFrame: 10 days (average time of discharge from the hospital)
measure: Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU)
timeFrame: 2 days (average time of discharge from ICU)
measure: Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU)
timeFrame: 10 days (average time of discharge from the hospital)
measure: Composite of Perioperative Complications
timeFrame: 10 days (average time of discharge from the hospital)
measure: Duration of Intubation
timeFrame: 10 days (average time of discharge from the hospital)
measure: Length of Intensive Care Unit (ICU) Stay
timeFrame: 2 days (average time of discharge from ICU)
measure: Total Length of Hospital Stay
timeFrame: 10 days (average time of discharge from the hospital)
measure: Number of Intensive Care Unit (ICU) Readmission
timeFrame: 10 days (average time of discharge from the hospital)
measure: Number of Cerebrovascular Events
timeFrame: 10 days (average time of discharge from the hospital)
measure: Number of Subjects Readmitted to the Hospital
timeFrame: 30 days
measure: Number of Subjects Returning to the ER Within 30 Days
timeFrame: 30 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory Univeristy Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: