- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00394407
Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes
Comparative Trial Between Insulin Glargine Plus Supplemental Glulisine (Apidra) Versus Sliding Scale Regular Insulin In Hospitalized Patients With Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will compare how well regular insulin will compare to glargine (Lantus®) once daily plus glulisine (Apidra®) insulin before meals in hospitalized patients with type 2 diabetes and elevated blood glucose (sugar) levels. Lantus is a long-acting insulin which is given subcutaneously (under the skin) once daily. Apidra is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Regular insulin is a short-acting insulin in clinical use for more than 20 years that is also given subcutaneously several times per day. Lantus, Apidra and regular insulins are approved for use in the treatment of patients with diabetes by the FDA.
This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Jackson Memorial Hospital, Miami. Dr. Umpierrez designed the study and will serve as principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at the Jackson Memorial Hospital. This study is supported by Sanofi-Aventis Pharmaceuticals.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33124
- University of Miami School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females between the ages of 18 and 70 years admitted to a general medicine service.
- 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).
Exclusion Criteria:
- Subjects with increased blood glucose concentration, but without a known history of diabetes.
- Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [57].
- Patients with known HIV, acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), corticosteroid therapy, or to undergo surgery during the hospitalization course.
- Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥3.0.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
- Female subjects are pregnant or breast feeding at time of enrollment into the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: sliding scale regular insulin
sliding scale insulin given acqhs
|
SSRI acqhs
Other Names:
|
Active Comparator: glargine insulin and glulisine insulin
glargine basal insulin once a day with prandial glulisine insulin tid
|
glargine insulin once a day and glulisine insulin three times a day as long as patient eating
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood glucose control
Time Frame: During hospitalization
|
Differences in BG control will be assessed between the 2 arms acqhs and as needed for those patients hospitalized on the non-medical floors
|
During hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
frequency of hypoglycemia
Time Frame: during the hospitalization
|
assess differences in the frequency of hypoglycemia between the 2 study arms
|
during the hospitalization
|
frequency of severe hyperglycemia (BG > 400 mg/dl),
Time Frame: during the hospitalization
|
evaluate differences in severe hyperglycemia between the 2 study arms
|
during the hospitalization
|
length of hospital stay
Time Frame: during hospitalization
|
differences in LOS between study arms
|
during hospitalization
|
inflammatory markers
Time Frame: during hospitalization
|
C-reactive protein, interleukin-6, and tumor necrosis factor
|
during hospitalization
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillermo E Umpierrez, MD, Emory University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 419-2005 (Other Identifier: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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