HyperglycemiaPhase 4SITA-CABGDMNCT02556918
Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery
A Phase 4 study testing Sitagliptin, Regular Human Insulin and Insulin glargine in people with Hyperglycemia, run by Emory University at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Sitagliptin, Regular Human Insulin and Insulin glargine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2016to 6 Nov 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Grady Health System
Atlanta, Georgia, 30303
Emory Univeristy Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Sitagliptin for the Prevention and Treatment of Hyperglycemia in Patients With Type 2 Diabetes 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).
Read the 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.
- Conditions
- Hyperglycemia
- Being tested
- Sitagliptin, Placebo, Regular Human Insulin, Insulin glargine, Supplemental insulin (Insulin lispro)
- Keywords
- Coronary artery bypass graft surgery (CABG), Type 2 Diabetes
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
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.
PlaceboDrug
One pill daily starting one day prior to surgery until discharge from the hospital.
Regular Human InsulinDrug
Also called Novolin-R, Humulin-R
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.
Insulin glargineDrug
Also called Lantus
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
Supplemental insulin (Insulin lispro)Drug
Also called Humalog
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
Supplemental insulin (Insulin aspart)Drug
Also called Novolog
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
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | 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) Receives: Drug: Sitagliptin; Drug: Regular Human Insulin; Drug: Insulin glargine; Drug: Supplemental insulin (Insulin lispro); Drug: Supplemental insulin (Insulin aspart) |
| Placebo | Placebo comparator | 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) Receives: Drug: Placebo; Drug: Regular Human Insulin; Drug: Insulin glargine; Drug: Supplemental insulin (Insulin lispro); Drug: Supplemental insulin (Insulin aspart) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU)
Number of patients with blood glucose (BG) levels greater than 180 mg/dl
Measured: 2 days (average time of discharge from ICU)
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).
Measured: 10 days (average time of discharge from the hospital)
Secondary outcomes (24)
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
Measured: 2 days (average time of discharge from ICU)
Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)
Mean blood glucose (BG) concentration of ICU patients during recovery period.
Measured: 2 days (average time of discharge from ICU)
Total IV Insulin in ICU
Total IV insulin in ICU during recovery period.
Measured: 2 days (average time of discharge from ICU)
Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery
Mean insulin infusion dose per day of ICU patients during recovery period.
Measured: 2 days (average time of discharge from ICU)
Duration of Continuous Intravenous Insulin Infusion (CII)
Total hours of continuous intravenous insulin infusion (CII)
Measured: Up to 48 hours (average time of discharge from ICU)
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)
Measured: 10 days (average time of discharge from the hospital)
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
Measured: Up to 14 days (time of discharge from the hospital)
Mean Post-operative Blood Glucose (BG) Concentration
Mean post-operative blood glucose (BG) concentration during recovery period.
Measured: 10 days (average time of discharge from the hospital)
Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)
Total amount of SC insulin taken by ICU patients during recovery period.
Measured: 2 days (average time of discharge from ICU)
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.
Measured: 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.
Measured: 2 days (average time of discharge from ICU)
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.
Measured: 10 days (average time of discharge from the hospital)
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).
Measured: 2 days (average time of discharge from 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).
Measured: 10 days (average time of discharge from the hospital)
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).
Measured: 2 days (average time of discharge from 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).
Measured: 10 days (average time of discharge from the hospital)
Composite of Perioperative Complications
Number of perioperative complications including hospital mortality, infection,acute renal failure, and acute mycordial infarction.
Measured: 10 days (average time of discharge from the hospital)
Duration of Intubation
Duration that patients required to be intubated
Measured: 10 days (average time of discharge from the hospital)
Length of Intensive Care Unit (ICU) Stay
Total number of days spent in intensive care unit (ICU)
Measured: 2 days (average time of discharge from ICU)
Total Length of Hospital Stay
Total number of days spent in hospital
Measured: 10 days (average time of discharge from the hospital)
Number of Intensive Care Unit (ICU) Readmission
Number of re-admissions to intensive care unit during the same hospital course.
Measured: 10 days (average time of discharge from the hospital)
Number of Cerebrovascular Events
Number of cerebrovascular events including permanent stroke and reversible ischemic neurologic deficit
Measured: 10 days (average time of discharge from the hospital)
Number of Subjects Readmitted to the Hospital
Number of subjects readmitted to the hospital within 30 days (all-cause).
Measured: 30 days
Number of Subjects Returning to the ER Within 30 Days
Number of subjects returning to the ER within 30 days (all-cause).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startJan 2016
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, MD, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556918
- Sponsor's protocol ID
- IRB00082180
- Acronym
- SITA-CABGDM
- Status last verified
- Dec 2019
- First submitted
- 21 Sep 2015
- Last updated
- 23 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin for the Prevention and Treatment of Hyperglycemia in Patients With Type 2 Diabetes Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02556918
- Acronym / sponsor ID
- SITA-CABGDM / IRB00082180
- Conditions
- Hyperglycemia
- Keywords
- Coronary artery bypass graft surgery (CABG), Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Posted 23 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | 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 (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) |
| Placebo | Placebo comparator | Drug: Placebo, 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitagliptinAlso: JanuviaSubjects 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. | Drug | Sitagliptin |
| PlaceboOne pill daily starting one day prior to surgery until discharge from the hospital. | Drug | Placebo |
| Regular Human InsulinAlso: Novolin-R, Humulin-RContinuous 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. | Drug | Placebo, Sitagliptin |
| Insulin glargineAlso: LantusPatients 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 | Drug | Placebo, Sitagliptin |
| Supplemental insulin (Insulin lispro)Also: HumalogInsulin 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 | Drug | Placebo, Sitagliptin |
| Supplemental insulin (Insulin aspart)Also: NovologInsulin 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 | Drug | Placebo, Sitagliptin |
Primary outcome
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
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).
24 secondary outcomes
Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII)
Time frame: 2 days (average time of discharge from ICU)
Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)
Time frame: 2 days (average time of discharge from ICU)
Total IV Insulin in ICU
Time frame: 2 days (average time of discharge from ICU)
Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery
Time frame: 2 days (average time of discharge from ICU)
Duration of Continuous Intravenous Insulin Infusion (CII)
Time frame: Up to 48 hours (average time of discharge from ICU)
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)
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)
Mean Post-operative Blood Glucose (BG) Concentration
Time frame: 10 days (average time of discharge from the hospital)
Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)
Time frame: 2 days (average time of discharge from ICU)
Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours
Time frame: 48 hours during recovery period
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 Non-ICU
Time frame: 10 days (average time of discharge from the hospital)
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 Hypoglycemic Events in Non-intensive Care Unit (ICU)
Time frame: 10 days (average time of discharge from the hospital)
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 Hypoglycemic Events in Non-intensive Care Unit (ICU)
Time frame: 10 days (average time of discharge from the hospital)
Composite of Perioperative Complications
Time frame: 10 days (average time of discharge from the hospital)
Duration of Intubation
Time frame: 10 days (average time of discharge from the hospital)
Length of Intensive Care Unit (ICU) Stay
Time frame: 2 days (average time of discharge from ICU)
Total Length of Hospital Stay
Time frame: 10 days (average time of discharge from the hospital)
Number of Intensive Care Unit (ICU) Readmission
Time frame: 10 days (average time of discharge from the hospital)
Number of Cerebrovascular Events
Time frame: 10 days (average time of discharge from the hospital)
Number of Subjects Readmitted to the Hospital
Time frame: 30 days
Number of Subjects Returning to the ER Within 30 Days
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hyperglycemia
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Umpierrez, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin, Regular Human Insulin and Insulin glargine in people with Hyperglycemia, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU) (time frame: 2 days (average time of discharge from ICU)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.