HyperglycemiaPhase 4NCT02741687
Sitagliptin in Non-Diabetic Patients Undergoing General Surgery
A Phase 4 study testing Sitagliptin, Supplemental insulin (insulin lispro) and Supplemental insulin (insulin aspart) in people with Hyperglycemia, run by Emory University at 2 sites in United States.
Trial summary
The purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery. 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, Supplemental insulin (insulin lispro) and Supplemental insulin (insulin aspart)
- 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
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to Apr 2017
- 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
- Undergoing non-cardiac surgery
- No previous history of diabetes or hyperglycemia
- Fasting blood glucose level of <126 mg/dl
- Blood glucose <126mg/dl at the time of randomization (could occur at any time of the day)
Who cannot join
- History of hyperglycemia (blood glucose equal to or above 126 mg/dl or HbA1C greater than 6.5%) or previous treatment with oral antidiabetic agents or insulin
- Patients undergoing cardiac surgery
- Patients anticipated to require ICU care following surgery
- Severely impaired renal function (GFR < 30 ml/min) or clinically significant hepatic failure
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
- Patients with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction
Show all 10Show fewer
- Patients with clinically relevant pancreatic or gallbladder disease
- Treatment with oral (> 5 mg/day) or injectable corticosteroid
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Pregnancy or breast-feeding at time of enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30322
About this study
Official title: Prevention of Stress Hyperglycemia With the Use of DPP-4 Inhibitors in Non-diabetic Patients Undergoing Non-cardiac Surgery, a Pilot Study
The purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery.
Read the detailed description
Approximately 30-40% of hospitalized patients will develop stress hyperglycemia (high glucose in response to surgery or illness). High glucose is linked to an increased risk of hospital complications including wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. Recent studies have found that inpatient therapy with oral dipeptidyl peptidase-4 inhibitor (DPP4-I) is an effective alternative to insulin in improving glycemic control with low risk of hypoglycemia in general medicine and surgical patients.
Sitagliptin is an oral medication approved by the Food and Drug Administration (FDA) to treat patients with diabetes. The aim of this study is to determine whether treatment with sitagliptin once daily can prevent the development of stress hyperglycemia during the postoperative period in non-diabetic patients undergoing general surgery.
- Conditions
- Hyperglycemia
- Being tested
- Sitagliptin, Placebo, Supplemental insulin (insulin lispro), Supplemental insulin (insulin aspart), Long acting basal insulin (insulin detemir)
- Keywords
- stress hyperglycemia, blood glucose
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
Participants will take 100 mg/day for patients with glomerular filtration rate (GFR) > 50 and 50 mg/day for GFR 30 - 49, beginning on the day prior to surgery and continuing through hospitalization, up to 10 days.
PlaceboDrug
Participants will take one pill daily beginning on the day prior to surgery and continuing through hospitalization, up to 10 days.
Supplemental insulin (insulin lispro)Drug
Also called Humalog
Supplemental 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) >240 mg/dL will be given. If a patient is unable to eat, supplemental insulin will be administered every 6 hours with the lowest number of units for that appropriate BG level.
For subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, the 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 > 400 mg/dL; 7-9 units of insulin lispro
Supplemental insulin (insulin aspart)Drug
Also called NovoLog
Supplemental 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) >240 mg/dL will be given. If a patient is unable to eat, supplemental insulin will be administered every 6 hours with the lowest number of units for that appropriate BG level.
For subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, the 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 > 400 mg/dL; 7-9 units of insulin lispro
Long acting basal insulin (insulin detemir)Drug
Also called Levemir
Long acting basal insulin therapy will be provided as needed, and will be given once daily, at the same time of day. Participants with blood glucose (BG) >180 mg/dL= start detemir at 0.2 units per kg weight per day and will follow the following adjustment schedule:
- 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 detemir or glargine dose by 10% every day
- Fasting and pre-meal BG >241 mg/dl: increase detemir or glargine dose by 20% every day
- Fasting and pre-meal BG <100 mg/dl: reduce detemir or glargine by 20% or stop if patient is already on less than 0.1 units/kg of body weight
Long acting basal insulin (insulin glargine)Drug
Also called Lantus
Long acting basal insulin therapy will be provided as needed, and will be given once daily, at the same time of day. Participants with blood glucose (BG) >180 mg/dL= start detemir at 0.2 units per kg weight per day and will follow the following adjustment schedule:
- 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 detemir or glargine dose by 10% every day
- Fasting and pre-meal BG >241 mg/dl: increase detemir or glargine dose by 20% every day
- Fasting and pre-meal BG <100 mg/dl: reduce detemir or glargine by 20% or stop if patient is already on less than 0.1 units/kg of body weight
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin Arm | Experimental | Participants will receive sitagliptin beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale. Receives: Drug: Sitagliptin; Drug: Supplemental insulin (insulin lispro); Drug: Supplemental insulin (insulin aspart); Drug: Long acting basal insulin (insulin detemir); Drug: Long acting basal insulin (insulin glargine) |
| Placebo Arm | Placebo comparator | Participants will receive a placebo tablet beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery).
Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care.
Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale. Receives: Drug: Placebo; Drug: Supplemental insulin (insulin lispro); Drug: Supplemental insulin (insulin aspart); Drug: Long acting basal insulin (insulin detemir); Drug: Long acting basal insulin (insulin glargine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Stress Hyperglycemia
The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL.
Measured: Up to time of discharge from hospital, an average of 10 days
Secondary outcomes (9)
Number of Patients Requiring Supplemental, Subcutaneous Insulin
Number of patients requiring subcutaneous insulin, either sliding scale insulin or basal insulin
Measured: Up to time of discharge from hospital, an average of 10 days
Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin
Total daily dose of insulin for patients requiring supplemental insulin during surgery and recovery in participants receiving sitagliptin and those receiving the placebo
Measured: Up to time of discharge from hospital, an average of 10 days
Length of Hospital Stay
Total length of hospital stay
Measured: Up to time of discharge from hospital, an average of 10 days
Number of Participants With Hypoglycemic Events
Number of participants experiencing at least one episode of mild hypoglycemia (blood glucose < 70 mg/dL) or clinically significant hypoglycemia (blood glucose < 54 mg/dL)
Measured: Up to time of discharge from hospital, an average of 10 days
Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization
The number of patients who were transferred to the ICU immediately following surgery or anytime while hospitalized after surgery.
Measured: Up to time of discharge from hospital, an average of 10 days
Number of Days in the ICU
The number of days a participant spent in the ICU following surgery, when transfer to the ICU was required.
Measured: Up to time of discharge from hospital, an average of 10 days
Number of Participants With Hospital Readmissions After Discharge
Readmissions to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any hospital readmissions to hospitals other than the one where the surgery occurred are not known.
Measured: Up to 40 days (average time of discharge from the hospital plus 30 days)
Number of Participants With Emergency Room Visits After Discharge
Emergency room visits to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any emergency room visits to hospitals other than the one where the surgery occurred are not known.
Measured: Up to 40 days (average time of discharge from the hospital plus 30 days)
Number of Participants Experiencing Complications
The number of subjects who experience complications including: wound infection, respiratory failure, pneumonia, acute kidney injury with a rise in creatinine by 38 micromoles/Liter from baseline, major adverse cardiac events, bacterial septic infection, and death. Participants will be followed for 30 days following hospital discharge and all complications will be documented.
Measured: Up to 40 days (average time of discharge from the hospital plus 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completionApr 2017
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Fayfman, Emory University
- Investigators
- Maya Fayfman, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741687
- Sponsor's protocol ID
- IRB00087357
- Status last verified
- May 2018
- First submitted
- 13 Apr 2016
- Last updated
- 27 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Stress Hyperglycemia With the Use of DPP-4 Inhibitors in Non-diabetic Patients Undergoing Non-cardiac Surgery, a Pilot Study
- ClinicalTrials.gov ID
- NCT02741687
- Acronym / sponsor ID
- IRB00087357
- Conditions
- Hyperglycemia
- Keywords
- stress hyperglycemia, blood glucose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Posted 27 Jun 2018
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 compare sitagliptin with a placebo for the prevention of high glucose after general surgery.
Detailed description
Approximately 30-40% of hospitalized patients will develop stress hyperglycemia (high glucose in response to surgery or illness). High glucose is linked to an increased risk of hospital complications including wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. Recent studies have found that inpatient therapy with oral dipeptidyl peptidase-4 inhibitor (DPP4-I) is an effective alternative to insulin in improving glycemic control with low risk of hypoglycemia in general medicine and surgical patients.
Sitagliptin is an oral medication approved by the Food and Drug Administration (FDA) to treat patients with diabetes. The aim of this study is to determine whether treatment with sitagliptin once daily can prevent the development of stress hyperglycemia during the postoperative period in non-diabetic patients undergoing general surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin Arm | Experimental | Drug: Sitagliptin, Drug: Supplemental insulin (insulin lispro), Drug: Supplemental insulin (insulin aspart), Drug: Long acting basal insulin (insulin detemir), Drug: Long acting basal insulin (insulin glargine)Participants will receive sitagliptin beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery). Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care. Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale. |
| Placebo Arm | Placebo comparator | Drug: Placebo, Drug: Supplemental insulin (insulin lispro), Drug: Supplemental insulin (insulin aspart), Drug: Long acting basal insulin (insulin detemir), Drug: Long acting basal insulin (insulin glargine)Participants will receive a placebo tablet beginning the day prior to surgery and continuing daily during hospitalization (up to 10 days post-surgery). Point of care (POC) testing will be done four times daily, before meals and at bedtime, or every 6 hours for patients who are not eating (NPO). Patients developing hyperglycemia during or after surgery will be treated with insulin per standard of care. Patients with fasting and/or premeal blood glucose levels >180 mg/dl will receive supplemental insulin provided on a sliding scale. Patients with two consecutive fasting and/or premeal blood glucose levels >180 mg/dl, or with average daily blood glucose levels >180 mg/dl will be started on rescue therapy with subcutaneous insulin once daily plus correction doses by a sliding scale. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing non-cardiac surgery
- No previous history of diabetes or hyperglycemia
- Fasting blood glucose level of <126 mg/dl
- Blood glucose <126mg/dl at the time of randomization (could occur at any time of the day)
Key exclusion criteria (10 listed)
- History of hyperglycemia (blood glucose equal to or above 126 mg/dl or HbA1C greater than 6.5%) or previous treatment with oral antidiabetic agents or insulin
- Patients undergoing cardiac surgery
- Patients anticipated to require ICU care following surgery
- Severely impaired renal function (GFR < 30 ml/min) or clinically significant hepatic failure
- Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
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: JanuviaParticipants will take 100 mg/day for patients with glomerular filtration rate (GFR) > 50 and 50 mg/day for GFR 30 - 49, beginning on the day prior to surgery and continuing through hospitalization, up to 10 days. | Drug | Sitagliptin Arm |
| PlaceboParticipants will take one pill daily beginning on the day prior to surgery and continuing through hospitalization, up to 10 days. | Drug | Placebo Arm |
| Supplemental insulin (insulin lispro)Also: HumalogSupplemental 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) >240 mg/dL will be given. If a patient is unable to eat, supplemental insulin will be administered every 6 hours with the lowest number of units for that appropriate BG level. For subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, the 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 > 400 mg/dL; 7-9 units of insulin lispro | Drug | Placebo Arm, Sitagliptin Arm |
| Supplemental insulin (insulin aspart)Also: NovoLogSupplemental 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) >240 mg/dL will be given. If a patient is unable to eat, supplemental insulin will be administered every 6 hours with the lowest number of units for that appropriate BG level. For subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, the 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 > 400 mg/dL; 7-9 units of insulin lispro | Drug | Placebo Arm, Sitagliptin Arm |
| Long acting basal insulin (insulin detemir)Also: LevemirLong acting basal insulin therapy will be provided as needed, and will be given once daily, at the same time of day. Participants with blood glucose (BG) >180 mg/dL= start detemir at 0.2 units per kg weight per day and will follow the following adjustment schedule: * 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 detemir or glargine dose by 10% every day * Fasting and pre-meal BG >241 mg/dl: increase detemir or glargine dose by 20% every day * Fasting and pre-meal BG <100 mg/dl: reduce detemir or glargine by 20% or stop if patient is already on less than 0.1 units/kg of body weight | Drug | Placebo Arm, Sitagliptin Arm |
| Long acting basal insulin (insulin glargine)Also: LantusLong acting basal insulin therapy will be provided as needed, and will be given once daily, at the same time of day. Participants with blood glucose (BG) >180 mg/dL= start detemir at 0.2 units per kg weight per day and will follow the following adjustment schedule: * 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 detemir or glargine dose by 10% every day * Fasting and pre-meal BG >241 mg/dl: increase detemir or glargine dose by 20% every day * Fasting and pre-meal BG <100 mg/dl: reduce detemir or glargine by 20% or stop if patient is already on less than 0.1 units/kg of body weight | Drug | Placebo Arm, Sitagliptin Arm |
Primary outcome
Number of Participants Experiencing Stress Hyperglycemia
Time frame: Up to time of discharge from hospital, an average of 10 days
The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL.
9 secondary outcomes
Number of Patients Requiring Supplemental, Subcutaneous Insulin
Time frame: Up to time of discharge from hospital, an average of 10 days
Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin
Time frame: Up to time of discharge from hospital, an average of 10 days
Length of Hospital Stay
Time frame: Up to time of discharge from hospital, an average of 10 days
Number of Participants With Hypoglycemic Events
Time frame: Up to time of discharge from hospital, an average of 10 days
Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization
Time frame: Up to time of discharge from hospital, an average of 10 days
Number of Days in the ICU
Time frame: Up to time of discharge from hospital, an average of 10 days
Number of Participants With Hospital Readmissions After Discharge
Time frame: Up to 40 days (average time of discharge from the hospital plus 30 days)
Number of Participants With Emergency Room Visits After Discharge
Time frame: Up to 40 days (average time of discharge from the hospital plus 30 days)
Number of Participants Experiencing Complications
Time frame: Up to 40 days (average time of discharge from the hospital plus 30 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maya Fayfman, MD principal investigator
Emory University
2 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, Supplemental insulin (insulin lispro) and Supplemental insulin (insulin aspart) in people with Hyperglycemia, run by Emory University at 2 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 4 inclusion and 10 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 27 Jun 2018). 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 Participants Experiencing Stress Hyperglycemia (time frame: Up to time of discharge from hospital, an average of 10 days). 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 27 Jun 2018.