DiabetesPhase 4NOVO ERNCT00663624
Management of Hyperglycemia in the ER: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care
A Phase 4 study testing aspart insulin in people with Diabetes, run by Emory University.
Trial summary
In the Emergency Department (ED), diabetes is commonly encountered as a secondary diagnosis and many patients with uncontrolled diabetes are admitted to the hospital after initial evaluation in the ED. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- aspart insulin
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Subjects meeting all of the following criteria will be considered for enrollment into the study:
- Males or females between the ages of 18 and 80 years admitted to a general medical service.
- A known history of type 2 diabetes mellitus > 3 months, receiving diet management, any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy.
- Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL and no evidence of ketoacidosis (serum bicarbonate < 18 mEq/L, venous or arterial pH < 7.30, positive serum or urinary ketones).
Who cannot join
- Subjects with increased blood glucose concentration, but without a known history of diabetes.
- Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
- Patients with acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), or to undergo surgery during the hospitalization course.
- History of current drug or alcohol abuse.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Inability to give informed consent
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- Female patients who are pregnant or are breast feeding
- Patients who have clinically significant liver disease with ALT/AST > 3 X the upper range of normal
- Patients with serum creatinine ≥3.5 mg/dL for males or ≥ 3.0 mg/dL for females or currently treated with dialysis
About this study
Official title: Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care
In the Emergency Department (ED), diabetes is commonly encountered as a secondary diagnosis and many patients with uncontrolled diabetes are admitted to the hospital after initial evaluation in the ED. Currently there are no guidelines in the US for the management of hyperglycemia in patients with diabetes during the duration of evaluation and treatment in the ED. It is known that high blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. In this study, we hypothesize that a defined two-step approach to the management of high blood sugars with insulin injections initiated in the ED may decrease length of stay in the ED or hospital, improve clinical outcome and prevent some hospital complications. In the first phase, patients with diabetes admitted to the ED that have a high blood sugar (BG 200mg/dL) will be randomized to receive scheduled aspart or the usual care as dictated by the ED physicians. In the second phase, patients enrolled in the first phase that are subsequently admitted to the hospital will receive a combination of detemir and aspart insulin or usual care as dictated by the Admitting Medicine Team. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA. Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine.
This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Smiley will serve as principal investigator at the Atlanta site. A total of 120 patients will be recruited at Grady and 120 patients at the Rush University Medical Center, Chicago, IL. This study is supported by Novo Nordisk.
- Conditions
- Diabetes
- Being tested
- aspart insulin, Usual care as prescribed by the ED physicians.
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspart insulinDrug
subcutaneous aspart insulin every 2 hours
Usual care as prescribed by the ED physicians.Drug
Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Subcutaneous aspart insulin every 2 hours Receives: Drug: aspart insulin |
| Active Comparator | Placebo comparator | Usual care as prescribed by the ED physicians Receives: Drug: Usual care as prescribed by the ED physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether initiation of hyperglycemia management in the ED with scheduled aspart insulin for patients versus usual care with type 2 diabetes will result in a decrease in subsequent hospital length of stay.
Measured: once all subjects have been recruited
Secondary outcomes (1)
to determine diff. in the mean BG during the ED stay, the mean BG achieved during hospital, frequency of hypoglycemia during the ED and hospital visits among those treated with the scheduled protocol insulin regimen vs. usual hyperglycemia mgmt
Measured: once all subjects have been recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
Why it stopped: Lack of funding for the study at the Emory site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Dawn Smiley MD, Emory University
- Investigators
- Dawn Smiley, MD, Principal investigator, Emory SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663624
- Sponsor's protocol ID
- IRB00008143
- Other IDs
- e8143
- Acronym
- NOVO ER
- Status last verified
- Nov 2013
- First submitted
- 18 Apr 2008
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Hyperglycemia in the Emergency Room: A Randomized Clinical Trial of a Subcutaneous Insulin Aspart Protocol Coupled With Rapid Initiation of Basal Bolus Insulin Prior to Hospital Admission Versus Usual Care
- ClinicalTrials.gov ID
- NCT00663624
- Acronym / sponsor ID
- NOVO ER / IRB00008143
- Conditions
- Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding for the study at the Emory site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the Emergency Department (ED), diabetes is commonly encountered as a secondary diagnosis and many patients with uncontrolled diabetes are admitted to the hospital after initial evaluation in the ED. Currently there are no guidelines in the US for the management of hyperglycemia in patients with diabetes during the duration of evaluation and treatment in the ED. It is known that high blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. In this study, we hypothesize that a defined two-step approach to the management of high blood sugars with insulin injections initiated in the ED may decrease length of stay in the ED or hospital, improve clinical outcome and prevent some hospital complications. In the first phase, patients with diabetes admitted to the ED that have a high blood sugar (BG 200mg/dL) will be randomized to receive scheduled aspart or the usual care as dictated by the ED physicians. In the second phase, patients enrolled in the first phase that are subsequently admitted to the hospital will receive a combination of detemir and aspart insulin or usual care as dictated by the Admitting Medicine Team. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA. Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine.
This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Smiley will serve as principal investigator at the Atlanta site. A total of 120 patients will be recruited at Grady and 120 patients at the Rush University Medical Center, Chicago, IL. This study is supported by Novo Nordisk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: aspart insulinSubcutaneous aspart insulin every 2 hours |
| Active Comparator | Placebo comparator | Drug: Usual care as prescribed by the ED physicians.Usual care as prescribed by the ED physicians |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects meeting all of the following criteria will be considered for enrollment into the study:
- Males or females between the ages of 18 and 80 years admitted to a general medical service.
- A known history of type 2 diabetes mellitus > 3 months, receiving diet management, any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy.
- Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL and no evidence of ketoacidosis (serum bicarbonate < 18 mEq/L, venous or arterial pH < 7.30, positive serum or urinary ketones).
Key exclusion criteria (9 listed)
- Subjects with increased blood glucose concentration, but without a known history of diabetes.
- Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
- Patients with acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), or to undergo surgery during the hospitalization course.
- History of current drug or alcohol abuse.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
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 |
|---|---|---|
| aspart insulinsubcutaneous aspart insulin every 2 hours | Drug | Experimental |
| Usual care as prescribed by the ED physicians.Usual care can be oral anti-diabetic agents, subcutaneous insulin therapy or a combination of both. Subcutaneous insulin used for usual care could include NPH, 70/30 insulin, aspart insulin, regular insulin or insulin glargine | Drug | Active Comparator |
Primary outcome
to determine whether initiation of hyperglycemia management in the ED with scheduled aspart insulin for patients versus usual care with type 2 diabetes will result in a decrease in subsequent hospital length of stay.
Time frame: once all subjects have been recruited
1 secondary outcome
to determine diff. in the mean BG during the ED stay, the mean BG achieved during hospital, frequency of hypoglycemia during the ED and hospital visits among those treated with the scheduled protocol insulin regimen vs. usual hyperglycemia mgmt
Time frame: once all subjects have been recruited
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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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.
Dawn Smiley, MD principal investigator
Emory SOM
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspart insulin in people with Diabetes, run by Emory University.
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 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: withdrawn, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
to determine whether initiation of hyperglycemia management in the ED with scheduled aspart insulin for patients versus usual care with type 2 diabetes will result in a decrease in subsequent hospital length of stay. (time frame: once all subjects have been recruited). 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 21 Nov 2013.