Status:
COMPLETED
Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)
Lead Sponsor:
Guillermo Umpierrez, MD
Collaborating Sponsors:
Sanofi
Medical University of South Carolina
Conditions:
Type 2 Diabetes
Hyperglycemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The study is a prospective randomized study comparing safety and effectiveness of a basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once dai...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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, dipeptidyl peptidase (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 milliequivalent /L, potential hydrogen (pH) \< 7.30, or positive serum or urinary ketones).
Exclusion
- 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 coronary artery bypass graft (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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00979628
Start Date
January 1 2010
End Date
June 1 2012
Last Update
October 10 2018
Active Locations (5)
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1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
Atlanta VA Medical Center
Decatur, Georgia, United States, 30030
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-6240