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Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery (SITA-CABGDM)

Primary Purpose

Hyperglycemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sitagliptin
Placebo
Regular Human Insulin
Insulin glargine
Supplemental insulin (Insulin lispro)
Supplemental insulin (Insulin aspart)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperglycemia focused on measuring Coronary artery bypass graft surgery (CABG), Type 2 Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grady Health System
  • Emory Univeristy Hospital Midtown
  • Emory University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sitagliptin

Placebo

Arm Description

Subjects undergoing cardiac surgery with type 2 diabetes (T2D) will be randomized to receive one tablet of sitagliptin once a day.Subjects with stress hyperglycemia (defined as a blood glucose (BG) greater than 180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level. Interventions: Drug: Sitagliptin Drug: Regular Human Insulin Drug: Insulin glargine Drug: Supplemental insulin (Insulin lispro) Drug: Supplemental insulin (Insulin aspart)

Subjects undergoing cardiac surgery with type 2 diabetes will be randomized to receive one tablet of placebo once a day.Subjects with stress hyperglycemia (defined as a blood glucose (BG) greater than 180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level. Interventions: Drug: Placebo Drug: Regular Human Insulin Drug: Insulin glargine Drug: Supplemental insulin (Insulin lispro) Drug: Supplemental insulin (Insulin aspart)

Outcomes

Primary Outcome Measures

Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU)
Number of patients with blood glucose (BG) levels greater than 180 mg/dl
Number of Patients With Persistent Hyperglycemia
Number of patients with two consecutive fasting and/or pre-meal blood glucose (BG) greater than 180 mg/dl, or with average daily BG greater than 80 mg/dl who require rescue therapy with subcutaneous (SC) insulin after discontinuation of continuous intravenous insulin infusion (CII).

Secondary Outcome Measures

Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII)
Number of patients requiring CII to achieve a blood glucose level (BG) target between 150-200 mg/dl
Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)
Mean blood glucose (BG) concentration of ICU patients during recovery period.
Total IV Insulin in ICU
Total IV insulin in ICU during recovery period.
Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery
Mean insulin infusion dose per day of ICU patients during recovery period.
Duration of Continuous Intravenous Insulin Infusion (CII)
Total hours of continuous intravenous insulin infusion (CII)
Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)
Number of patients requiring subcutaneous (SQ) insulin after discontinuation of continuous intravenous insulin infusion (CII)
Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)
Median number of days patients requiring SC insulin after discontinuation of CII
Mean Post-operative Blood Glucose (BG) Concentration
Mean post-operative blood glucose (BG) concentration during recovery period.
Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)
Total amount of SC insulin taken by ICU patients during recovery period.
Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours
Amount of subcutaneous (SC) insulin in intensive care unit (ICU) 48 hours during recovery period.
Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU)
Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in ICU recovery period.
Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU
Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in non-ICU recovery period.
Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU)
Number of patients with events (blood glucose less than 70 mg/dL) in patients in intensive care unit (ICU).
Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU)
Number of Patients With hypoglycemic events (blood glucose less than 70 mg/dL) in patients in non-intensive care unit (ICU).
Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU)
Number of Patients With severe hypoglycemia (blood glucose less than 40 mg/dL) in patients in intensive care unit (ICU).
Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU)
Number of Patients With hypoglycemic events (blood glucose less than 40 mg/dL) in patients in non-intensive care unit (ICU).
Composite of Perioperative Complications
Number of perioperative complications including hospital mortality, infection,acute renal failure, and acute mycordial infarction.
Duration of Intubation
Duration that patients required to be intubated
Length of Intensive Care Unit (ICU) Stay
Total number of days spent in intensive care unit (ICU)
Total Length of Hospital Stay
Total number of days spent in hospital
Number of Intensive Care Unit (ICU) Readmission
Number of re-admissions to intensive care unit during the same hospital course.
Number of Cerebrovascular Events
Number of cerebrovascular events including permanent stroke and reversible ischemic neurologic deficit
Number of Subjects Readmitted to the Hospital
Number of subjects readmitted to the hospital within 30 days (all-cause).
Number of Subjects Returning to the ER Within 30 Days
Number of subjects returning to the ER within 30 days (all-cause).

Full Information

First Posted
September 21, 2015
Last Updated
December 20, 2019
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02556918
Brief Title
Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery
Acronym
SITA-CABGDM
Official Title
Sitagliptin for the Prevention and Treatment of Hyperglycemia in Patients With Type 2 Diabetes Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
November 6, 2018 (Actual)
Study Completion Date
November 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Coronary artery bypass graft surgery (CABG), Type 2 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin
Arm Type
Experimental
Arm Description
Subjects undergoing cardiac surgery with type 2 diabetes (T2D) will be randomized to receive one tablet of sitagliptin once a day.Subjects with stress hyperglycemia (defined as a blood glucose (BG) greater than 180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level. Interventions: Drug: Sitagliptin Drug: Regular Human Insulin Drug: Insulin glargine Drug: Supplemental insulin (Insulin lispro) Drug: Supplemental insulin (Insulin aspart)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects undergoing cardiac surgery with type 2 diabetes will be randomized to receive one tablet of placebo once a day.Subjects with stress hyperglycemia (defined as a blood glucose (BG) greater than 180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level. Interventions: Drug: Placebo Drug: Regular Human Insulin Drug: Insulin glargine Drug: Supplemental insulin (Insulin lispro) Drug: Supplemental insulin (Insulin aspart)
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100 mg/day for patients with a glomeruler filtration rate (GFR) greater than or equal to 50. Patients with a GFR between 30-49 will receive 50 mg/day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One pill daily starting one day prior to surgery until discharge from the hospital.
Intervention Type
Drug
Intervention Name(s)
Regular Human Insulin
Other Intervention Name(s)
Novolin-R, Humulin-R
Intervention Description
Continuous intravenous insulin given to intensive care unit (ICU) patients with a blood glucose (BG) greater than 180 mg/DL and will be started on Regular Human Insulin adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol.Intravenous insulin infusion will be continued until the patient is able to eat and/or is transferred to non-ICU service. In previous studies, average length of insulin infusion in patients with stress hyperglycemia was 16.9±19 hours and the amount of IV insulin requirement was 18.6±24.3 U/day.
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Other Intervention Name(s)
Lantus
Intervention Description
Patients that required continuous insulin infusion (CII) at a rate >1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Give 50% of calculated dose as basal (glargine/detemir) insulin every day. Basal insulin will be given approx. 4 hours before discontinuation of CII. The total daily insulin dose will be adjusted as follow: Fasting and pre-meal BG between 100-180 mg/dl without hypoglycemia the previous day: no change Fasting and pre-meal BG between >180-240 mg/dl: increase basal dose by 10% every day Fasting and pre-meal BG >241 mg/dl: increase basal dose by 20% every day Fasting and pre-meal BG <100 mg/dl: stop basal
Intervention Type
Drug
Intervention Name(s)
Supplemental insulin (Insulin lispro)
Other Intervention Name(s)
Humalog
Intervention Description
Insulin lispro will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at blood glucose (BG) greater than 240 mg/dL will be given. For the subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows: BG between 181-220 mg/dL; 2-4 units of insulin lispro BG between 221-260 mg/dL; 3-5 units of insulin lispro BG between 261-300 mg/dL; 4-6 units of insulin lispro BG between 301-350 mg/dL; 5-7 units of insulin lispro BG between 351-400 mg/dL; 6-8 units of insulin lispro BG greater than 400 mg/dL; 7-9 units of insulin lispro
Intervention Type
Drug
Intervention Name(s)
Supplemental insulin (Insulin aspart)
Other Intervention Name(s)
Novolog
Intervention Description
Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at blood glucose (BG) greater than 240 mg/dL will be given. For the subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows: BG between 181-220 mg/dL; 2-4 units of insulin aspart BG between 221-260 mg/dL; 3-5 units of insulin aspart BG between 261-300 mg/dL; 4-6 units of insulin aspart BG between 301-350 mg/dL; 5-7 units of insulin aspart BG between 351-400 mg/dL; 6-8 units of insulin aspart BG greater than 400 mg/dL; 7-9 units of insulin aspart
Primary Outcome Measure Information:
Title
Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU)
Description
Number of patients with blood glucose (BG) levels greater than 180 mg/dl
Time Frame
2 days (average time of discharge from ICU)
Title
Number of Patients With Persistent Hyperglycemia
Description
Number of patients with two consecutive fasting and/or pre-meal blood glucose (BG) greater than 180 mg/dl, or with average daily BG greater than 80 mg/dl who require rescue therapy with subcutaneous (SC) insulin after discontinuation of continuous intravenous insulin infusion (CII).
Time Frame
10 days (average time of discharge from the hospital)
Secondary Outcome Measure Information:
Title
Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII)
Description
Number of patients requiring CII to achieve a blood glucose level (BG) target between 150-200 mg/dl
Time Frame
2 days (average time of discharge from ICU)
Title
Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)
Description
Mean blood glucose (BG) concentration of ICU patients during recovery period.
Time Frame
2 days (average time of discharge from ICU)
Title
Total IV Insulin in ICU
Description
Total IV insulin in ICU during recovery period.
Time Frame
2 days (average time of discharge from ICU)
Title
Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery
Description
Mean insulin infusion dose per day of ICU patients during recovery period.
Time Frame
2 days (average time of discharge from ICU)
Title
Duration of Continuous Intravenous Insulin Infusion (CII)
Description
Total hours of continuous intravenous insulin infusion (CII)
Time Frame
Up to 48 hours (average time of discharge from ICU)
Title
Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)
Description
Number of patients requiring subcutaneous (SQ) insulin after discontinuation of continuous intravenous insulin infusion (CII)
Time Frame
10 days (average time of discharge from the hospital)
Title
Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)
Description
Median number of days patients requiring SC insulin after discontinuation of CII
Time Frame
Up to 14 days (time of discharge from the hospital)
Title
Mean Post-operative Blood Glucose (BG) Concentration
Description
Mean post-operative blood glucose (BG) concentration during recovery period.
Time Frame
10 days (average time of discharge from the hospital)
Title
Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)
Description
Total amount of SC insulin taken by ICU patients during recovery period.
Time Frame
2 days (average time of discharge from ICU)
Title
Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours
Description
Amount of subcutaneous (SC) insulin in intensive care unit (ICU) 48 hours during recovery period.
Time Frame
48 hours during recovery period
Title
Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU)
Description
Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in ICU recovery period.
Time Frame
2 days (average time of discharge from ICU)
Title
Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU
Description
Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in non-ICU recovery period.
Time Frame
10 days (average time of discharge from the hospital)
Title
Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU)
Description
Number of patients with events (blood glucose less than 70 mg/dL) in patients in intensive care unit (ICU).
Time Frame
2 days (average time of discharge from ICU)
Title
Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU)
Description
Number of Patients With hypoglycemic events (blood glucose less than 70 mg/dL) in patients in non-intensive care unit (ICU).
Time Frame
10 days (average time of discharge from the hospital)
Title
Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU)
Description
Number of Patients With severe hypoglycemia (blood glucose less than 40 mg/dL) in patients in intensive care unit (ICU).
Time Frame
2 days (average time of discharge from ICU)
Title
Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU)
Description
Number of Patients With hypoglycemic events (blood glucose less than 40 mg/dL) in patients in non-intensive care unit (ICU).
Time Frame
10 days (average time of discharge from the hospital)
Title
Composite of Perioperative Complications
Description
Number of perioperative complications including hospital mortality, infection,acute renal failure, and acute mycordial infarction.
Time Frame
10 days (average time of discharge from the hospital)
Title
Duration of Intubation
Description
Duration that patients required to be intubated
Time Frame
10 days (average time of discharge from the hospital)
Title
Length of Intensive Care Unit (ICU) Stay
Description
Total number of days spent in intensive care unit (ICU)
Time Frame
2 days (average time of discharge from ICU)
Title
Total Length of Hospital Stay
Description
Total number of days spent in hospital
Time Frame
10 days (average time of discharge from the hospital)
Title
Number of Intensive Care Unit (ICU) Readmission
Description
Number of re-admissions to intensive care unit during the same hospital course.
Time Frame
10 days (average time of discharge from the hospital)
Title
Number of Cerebrovascular Events
Description
Number of cerebrovascular events including permanent stroke and reversible ischemic neurologic deficit
Time Frame
10 days (average time of discharge from the hospital)
Title
Number of Subjects Readmitted to the Hospital
Description
Number of subjects readmitted to the hospital within 30 days (all-cause).
Time Frame
30 days
Title
Number of Subjects Returning to the ER Within 30 Days
Description
Number of subjects returning to the ER within 30 days (all-cause).
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Umpierrez, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory Univeristy Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery

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