Type 2 DiabetesPhase 4RABBIT 2-SXNCT00596687
Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery
A Phase 4 study testing Insulin glargine, Regular insulin and Insulin glulisine in people with Type 2 Diabetes and Inpatient Hyperglycemia, run by Emory University at 2 sites in United States.
Trial summary
High blood glucose levels in surgical patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Inpatient Hyperglycemia
- What is being tested?
- Insulin glargine, Regular insulin and Insulin glulisine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Jul 2013
- 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
- Males or females between the ages of 18 and 80 years admitted to a general surgery service.
- Patients admitted for non-cardiac elective or emergency surgery or trauma.
- A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
- Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
Who cannot join
- Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
- Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
- Acute critical illness or CABG surgery expected to require prolonged admission to a critical care unit (ICU, CCU, SICU, Neuro ICU).
- Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥ 3.5 mg/dl.
- 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
2 sites in 1 country.
United States2 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital
Atlanta, Georgia, 30324
About this study
Official title: RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes Undergoing General Surgery (RABBIT 2 Surgery)
High blood glucose levels in surgical patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. In patients who have undergone surgery, high blood glucose increases the risk of wound infection, kidney failure and death. It is not known; however, what is the best insulin regimen in patients who will undergo surgery. The use of repeated injections of regular insulin is commonly used for glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus® and Apidra® insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar). We hypothesize that in patients with type 2 diabetes admitted to general surgery wards, treatment with once daily glargine (Lantus) plus supplemental glulisine insulin (Apidra®) will produce better glycemic control and a lower rate of hospital complications than treatment with regular insulin per sliding scale (SSRI). The present study aims to determine which insulin treatment is best for glucose control in hospitalized patients with diabetes. Glargine and glulisine insulins are approved for use in the treatment of patients with diabetes by the FDA.
Subjects included in the study will have type 2 diabetes and be admitted to Grady Memorial Hospital, Veterans Administration Medical Center, and Emory University Hospital, Atlanta, Georgia. A total of ~94 patients will be recruited at each institution.
A post-hoc cost analysis of hospitalization costs and charges of the Rabbit surgery trial will be completed in order to determine differences in hospitalization cost between basal bolus insulin and SSI regimen.
- Conditions
- Type 2 Diabetes, Inpatient Hyperglycemia
- Being tested
- Insulin glargine, Regular insulin, Insulin glulisine
- Keywords
- diabetes, post-op complications, inpatient hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargineDrug
Also called Lantus
Insulin glargine once daily SQ
Regular insulinDrug
Also called Novolin R
Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO
Insulin glulisineDrug
Also called Apidra
scheduled glulisine given SQ at mealtime TID; none given if patient NPO
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Glargine once daily plus glulisine given before meals plus supplemental glulisine for BG > 140 Receives: Drug: Insulin glargine; Drug: Insulin glulisine |
| 2 | Active comparator | Sliding scale regular insulin four-times daily achs. Receives: Drug: Regular insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Blood Glucose Concentration
blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment
Measured: hospital stay days 2-10
Secondary outcomes (1)
# Participants With Hypoglycemic Events
number of participants in the treatment arms with of hypoglycemic events (< 70 mg/dl)
Measured: hospital stay days 2-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionJul 2013
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596687
- Sponsor's protocol ID
- IRB00005062
- Other IDs
- e5062
- Acronym
- RABBIT 2-SX
- Status last verified
- Feb 2014
- First submitted
- 8 Jan 2008
- Last updated
- 12 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.
PubMed 21228246Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Ceron M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14.
PubMed 19366972
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients With Type 2 Diabetes Undergoing General Surgery (RABBIT 2 Surgery)
- ClinicalTrials.gov ID
- NCT00596687
- Acronym / sponsor ID
- RABBIT 2-SX / IRB00005062
- Conditions
- Type 2 Diabetes, Inpatient Hyperglycemia
- Keywords
- diabetes, post-op complications, inpatient hyperglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Posted 12 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High blood glucose levels in surgical patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. In patients who have undergone surgery, high blood glucose increases the risk of wound infection, kidney failure and death. It is not known; however, what is the best insulin regimen in patients who will undergo surgery. The use of repeated injections of regular insulin is commonly used for glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus® and Apidra® insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar). We hypothesize that in patients with type 2 diabetes admitted to general surgery wards, treatment with once daily glargine (Lantus) plus supplemental glulisine insulin (Apidra®) will produce better glycemic control and a lower rate of hospital complications than treatment with regular insulin per sliding scale (SSRI). The present study aims to determine which insulin treatment is best for glucose control in hospitalized patients with diabetes. Glargine and glulisine insulins are approved for use in the treatment of patients with diabetes by the FDA.
Subjects included in the study will have type 2 diabetes and be admitted to Grady Memorial Hospital, Veterans Administration Medical Center, and Emory University Hospital, Atlanta, Georgia. A total of ~94 patients will be recruited at each institution.
A post-hoc cost analysis of hospitalization costs and charges of the Rabbit surgery trial will be completed in order to determine differences in hospitalization cost between basal bolus insulin and SSI regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin glargine, Drug: Insulin glulisineGlargine once daily plus glulisine given before meals plus supplemental glulisine for BG > 140 |
| 2 | Active comparator | Drug: Regular insulinSliding scale regular insulin four-times daily achs. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females between the ages of 18 and 80 years admitted to a general surgery service.
- Patients admitted for non-cardiac elective or emergency surgery or trauma.
- A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
- Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
Key exclusion criteria (6 listed)
- Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
- Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
- Acute critical illness or CABG surgery expected to require prolonged admission to a critical care unit (ICU, CCU, SICU, Neuro ICU).
- Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥ 3.5 mg/dl.
- 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 |
|---|---|---|
| Insulin glargineAlso: LantusInsulin glargine once daily SQ | Drug | 1 |
| Regular insulinAlso: Novolin RSliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO | Drug | 2 |
| Insulin glulisineAlso: Apidrascheduled glulisine given SQ at mealtime TID; none given if patient NPO | Drug | 1 |
Primary outcome
Mean Blood Glucose Concentration
Time frame: hospital stay days 2-10
blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment
1 secondary outcome
# Participants With Hypoglycemic Events
Time frame: hospital stay days 2-10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21228246Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.
- Derived from this study: PubMed 19366972Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Ceron M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14.
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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.
Guillermo Umpierrez, MD principal investigator
Emory University SOM
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 Insulin glargine, Regular insulin and Insulin glulisine in people with Type 2 Diabetes and Inpatient 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 6 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 12 Mar 2014. 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. 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 12 Mar 2014). 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?
Mean Blood Glucose Concentration (time frame: hospital stay days 2-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00596687, which also lists 2 linked publications.
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 12 Mar 2014.