Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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 daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI) on correction of insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guillermo Umpierrez; Guillermo Umpierrez, MD
• Collaborators: Medical University of South Carolina; Sanofi; Texas A&M University
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc

Criteria

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, 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 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 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.