Basal Bolus Versus Basal Insulin Regimen for the Treatment of Hospitalized Patients With Type 2 Diabetes Mellitus: a Randomized, Open Labeled, Non-inferiority Controlled Study
| City: |
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Temple |
| State: |
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Texas |
| Zip Code: |
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76508 |
| Conditions: |
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Diabetes Mellitus, Non-Insulin-Dependent - Hyperglycemia |
| Purpose: |
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High blood glucose levels in medical and surgery patients with diabetes are associated with
increased risk of in-hospital complications and death. Improved glucose control with
insulin injections may improve clinical outcome and prevent some of the hospital
complications. Numerous studies have shown that 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). The investigators' recent
preliminary data also indicate that a single daily dose of glargine plus corrective doses of
glulisine before meals if needed (Basal Plus) is effective in the management of medical and
surgical patients with type 2 diabetes mellitus (T2DM). The average daily blood glucose
(BG) levels in patients treated with Basal Plus is equivalent to levels in patients treated
with Basal Bolus with glargine once daily plus glulisine before meals (basal bolus regimen).
The mean daily BG levels in patients treated with basal plus are lower than those reported
in patients treated with sliding scale regular insulin (SSRI). Accordingly, the present
study aims to determine which insulin treatment is best for glucose control in hospitalized
patients with diabetes admitted to general medicine wards. Glargine, glulisine, and regular
insulins are approved for use in the treatment of patients with diabetes by the FDA.
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| Study Summary: |
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A total of 375 subjects with type 2 diabetes will be recruited in this study. The sites for
this study are Grady Memorial Hospital, Emory University Hospital, the Atlanta VA Medical
Center, Scott & White Memorial Hospital and Clinic, and Medical University of South
Carolina.
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| Criteria: |
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Inclusion Criteria:
- Males or females between the ages of 18 and 75 years admitted to a general medicine
or surgical services.
- A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone,
oral monotherapy, or with any combination of oral antidiabetic agents (sulfonylureas,
meglitinides, metformin, thiazolidinediones, DPP-IV inhibitors).
- Patients admitted for non-cardiac elective or emergency surgery or trauma.
- Subjects must have an admission BG > 140 mg and < 400 mg/dL without laboratory
evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive
serum or urinary ketones).
Exclusion Criteria:
- 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 [32].
- Patients with acute critical or surgical illness admitted to the ICU or expected to
require admission to the ICU.
- Patients admitted for CABG or patients receiving continuous insulin infusion.
- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and
portal hypertension), corticosteroid therapy, or impaired renal function (creatinine
≥ 3.0 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.
- 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.
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| NCT ID: |
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NCT00979628 |
| Primary Contact: |
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Principal Investigator
Guillermo Umpierrez, MD
Emory SOM
Guillermo Umpierrez, MD
Phone: 4047781665
Email: geumpie@emory.edu
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| Backup Contact: |
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Email: dsmiley@emory.edu
Dawn Smiley, MD
Phone: 4047781664
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| Location Contact: |
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Temple, Texas 76508
United States
Vivian Fonseca, MD
Phone: 254-215-0300
Email: vfonseca@swmail.sw.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
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