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Completed

NCT Number: NCT02556918

Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery

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).

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Key information

Conditions

Hyperglycemia Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory Univeristy Hospital Midtown, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin

Drug

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.

Other names: Januvia

Placebo

Drug

One pill daily starting one day prior to surgery until discharge from the hospital.

regular human insulin

Drug

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.

Other names: Novolin-R, Humulin-R

insulin glargine

Drug

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

Other names: Lantus

Supplemental insulin (insulin lispro)

Drug

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

Other names: Humalog

Supplemental insulin (insulin aspart)

Drug

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

Other names: Novolog

Primary outcomes

  1. Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU)

    Time frame: 2 days (average time of discharge from ICU)

    Number of patients with blood glucose (BG) levels greater than 180 mg/dl

  2. Number of Patients With Persistent Hyperglycemia

    Time frame: 10 days (average time of discharge from the hospital)

    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 outcomes

  1. Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII)

    Time frame: 2 days (average time of discharge from ICU)

    Number of patients requiring CII to achieve a blood glucose level (BG) target between 150-200 mg/dl

  2. Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)

    Time frame: 2 days (average time of discharge from ICU)

    Mean blood glucose (BG) concentration of ICU patients during recovery period.

  3. Total IV Insulin in ICU

    Time frame: 2 days (average time of discharge from ICU)

    Total IV insulin in ICU during recovery period.

  4. Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery

    Time frame: 2 days (average time of discharge from ICU)

    Mean insulin infusion dose per day of ICU patients during recovery period.

  5. Duration of Continuous Intravenous Insulin Infusion (CII)

    Time frame: Up to 48 hours (average time of discharge from ICU)

    Total hours of continuous intravenous insulin infusion (CII)

  6. 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)

    Number of patients requiring subcutaneous (SQ) insulin after discontinuation of continuous intravenous insulin infusion (CII)

  7. Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)

    Time frame: Up to 14 days (time of discharge from the hospital)

    Median number of days patients requiring SC insulin after discontinuation of CII

  8. Mean Post-operative Blood Glucose (BG) Concentration

    Time frame: 10 days (average time of discharge from the hospital)

    Mean post-operative blood glucose (BG) concentration during recovery period.

  9. Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)

    Time frame: 2 days (average time of discharge from ICU)

    Total amount of SC insulin taken by ICU patients during recovery period.

  10. Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours

    Time frame: 48 hours during recovery period

    Amount of subcutaneous (SC) insulin in intensive care unit (ICU) 48 hours during recovery period.

  11. Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU)

    Time frame: 2 days (average time of discharge from ICU)

    Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in ICU recovery period.

  12. Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU

    Time frame: 10 days (average time of discharge from the hospital)

    Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in non-ICU recovery period.

  13. Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU)

    Time frame: 2 days (average time of discharge from ICU)

    Number of patients with events (blood glucose less than 70 mg/dL) in patients in intensive care unit (ICU).

  14. Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU)

    Time frame: 10 days (average time of discharge from the hospital)

    Number of Patients With hypoglycemic events (blood glucose less than 70 mg/dL) in patients in non-intensive care unit (ICU).

  15. Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU)

    Time frame: 2 days (average time of discharge from ICU)

    Number of Patients With severe hypoglycemia (blood glucose less than 40 mg/dL) in patients in intensive care unit (ICU).

  16. Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU)

    Time frame: 10 days (average time of discharge from the hospital)

    Number of Patients With hypoglycemic events (blood glucose less than 40 mg/dL) in patients in non-intensive care unit (ICU).

  17. Composite of Perioperative Complications

    Time frame: 10 days (average time of discharge from the hospital)

    Number of perioperative complications including hospital mortality, infection,acute renal failure, and acute mycordial infarction.

  18. Duration of Intubation

    Time frame: 10 days (average time of discharge from the hospital)

    Duration that patients required to be intubated

  19. Length of Intensive Care Unit (ICU) Stay

    Time frame: 2 days (average time of discharge from ICU)

    Total number of days spent in intensive care unit (ICU)

  20. Total Length of Hospital Stay

    Time frame: 10 days (average time of discharge from the hospital)

    Total number of days spent in hospital

  21. Number of Intensive Care Unit (ICU) Readmission

    Time frame: 10 days (average time of discharge from the hospital)

    Number of re-admissions to intensive care unit during the same hospital course.

  22. Number of Cerebrovascular Events

    Time frame: 10 days (average time of discharge from the hospital)

    Number of cerebrovascular events including permanent stroke and reversible ischemic neurologic deficit

  23. Number of Subjects Readmitted to the Hospital

    Time frame: 30 days

    Number of subjects readmitted to the hospital within 30 days (all-cause).

  24. Number of Subjects Returning to the ER Within 30 Days

    Time frame: 30 days

    Number of subjects returning to the ER within 30 days (all-cause).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Sitagliptin for the Prevention and Treatment of Hyperglycemia in Patients With Type 2 Diabetes Undergoing Cardiac Surgery

Acronym: SITA-CABGDM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 22, 2015
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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