Conditions: Type 2 Diabetes
Keywords: type 2 diabetes inpatient hyperglycemia SQ insulin Hospitalized patients with type 2 diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Detemir insulin once daily + aspart insulin before meals three times a day at an initial total dose of 0.5 units/kg/day, subcutaneously arm 2: NPH insulin once a day + regular insulin before breakfast and dinner at an initial total dose of 0.5 units/kg/day, subcutaneously

Interventions: intervention 1: Detemir + aspart insulin before meals intervention 2: NPH insulin + regular insulin
Intervention descriptions: intervention 1: Detemir insulin SQ once daily + aspart insulin SQ before meals intervention 2: NPH insulin SQ + regular insulin SQ before breakfast and dinner

Protocol document: