Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes; Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Intervention: sliding scale regular insulin (SSRI); Basal Bolus; Basal Plus
Intervention description: four-time daily in patients with T2DM admitted to general medicine and surgery wards.; glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed); glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes; Inpatient Hyperglycemia

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.
    

Eligibility 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.