Diabetes, Hyperglycemia
Conditions
Keywords
inpatient, diabetes management, insulin therapy
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 outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. The use of repeated injections of regular insulin (known as sliding scale regimen) is one of the most commonly used insulin regimen for glucose control in hospitalized patients with diabetes. Recently, the combination of basal and rapid acting insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar).
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.
Interventions
DRUGsliding scale regular insulin
SSRI acqhs
DRUGglargine basal insulin and glulisine prandial insulin
glargine insulin once a day and glulisine insulin three times a day as long as patient eating
Sponsors
Sanofi
University of Miami
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females between the ages of 18 and 70 years admitted to a general medicine service. 2. A known history of type 2 diabetes mellitus \> 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones). 3. 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
1. Subjects with increased blood glucose concentration, but without a known history of diabetes. 2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria \[57\]. 3. 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. 4. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥3.0. 5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 6. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism. 7. Female subjects are pregnant or breast feeding at time of enrollment into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood glucose control | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| frequency of hypoglycemia | during the hospitalization | assess differences in the frequency of hypoglycemia between the 2 study arms |
| frequency of severe hyperglycemia (BG > 400 mg/dl), | during the hospitalization | evaluate differences in severe hyperglycemia between the 2 study arms |
| length of hospital stay | during hospitalization | differences in LOS between study arms |
| inflammatory markers | during hospitalization | C-reactive protein, interleukin-6, and tumor necrosis factor |
Countries
United States
Outcome results
None listed