Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Detemir + aspart insulin before meals; NPH insulin + regular insulin
Intervention description: Detemir insulin SQ once daily + aspart insulin SQ before meals; NPH insulin SQ + regular insulin SQ before breakfast and dinner
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: type 2 diabetes; inpatient hyperglycemia; SQ insulin; Hospitalized patients with type 2 diabetes

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. Recently, the use of
      basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart,
      glulisine) has been shown to facilitate outpatient glycemic control with lower rate of
      hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will
      determine the efficacy and safety of the combination of detemir and aspart insulin in the
      inpatient management of subjects with diabetes. We hypothesize that in patients with type 2
      diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus
      insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic
      events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a
      long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a
      rapid-acting insulin which is given subcutaneously several times a day and frequently before
      meals. Detemir and aspart 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 Rush University Medical Center, Chicago, IL. 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 Rush University Medical Center, Chicago, IL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females between the ages of 18 and 70 years admitted to a general medical
             service.

          2. A known history of type 2 diabetes mellitus > 3 months, receiving any combination of
             oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin
             therapy.

          3. Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL and no evidence
             of ketoacidosis (serum bicarbonate < 18 mEq/L, venous or arterial pH < 7.30, 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 acute hyperglycemic crises such as diabetic ketoacidosis
             and hyperosmolar hyperglycemic state, or ketonuria [63].

          3. Patients with acute critical or surgical illness and/or expected to require admission
             to a critical care unit (ICU, CCU), or to undergo surgery during the hospitalization
             course.

          4. Patients with clinically relevant hepatic disease (ALT 2.5x > upper limit of normal),
             or impaired renal function, as shown by a serum creatinine ≥2.0 mg/dL for males, or ≥
             1.8 mg/dL for females.

          5. History of drug or alcohol abuse within the last 2 years.

          6. Mental condition rendering the subject unable to understand the nature, scope, and
             possible consequences of the study.

          7. Patients with recognized or suspected endocrine disorders associated with increased
             insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism.

          8. Female subjects are pregnant or breast feeding at time of enrollment into the study.