Status:
COMPLETED
Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 Diabetes
Lead Sponsor:
Emory University
Collaborating Sponsors:
Sanofi
University of Miami
Conditions:
Diabetes
Hyperglycemia
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief Summary
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outc...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00394407
Start Date
September 1 2005
End Date
June 1 2006
Last Update
November 21 2013
Active Locations (1)
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1
University of Miami School of Medicine
Coral Gables, Florida, United States, 33124