Few randomized studies have focused on the optimal management of non-ICU patients with type 2 diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen with analogs and human insulins in general medicine patients admitted to a University Hospital in Asuncion, Paraguay.
Few randomized intervention inpatient trials have been conducted in Latin America to determine optimal treatment regimens for patients with type 2 diabetes. In the absence of regional guidelines, most international societies in Latin America recommend following international guidelines for the management of hospitalized patients with diabetes. However, hospital resources, admission cause and inpatient glycemic control differ among countries. In the US, the leading cause of admission to the hospital in patients with diabetes is cardiovascular disease, whereas infections and acute complications of diabetes are more common than cardiovascular disease in some countries. The safety and efficacy of insulin regimens in non-ICU setting in Latin countries have not been determined. Objective: to compare the efficacy and safety of a basal-bolus regimen using insulin analogs with glargine once daily plus glulisine before meals to human insulin with NPH twice daily and regular insulin before meals in medicine patients with type 2 diabetes Outcome measures. To determine differences in glycemic control between groups as measured by mean daily BG concentration during the hospital stay. Secondary outcomes included differences between treatment groups in any of the following measures: number of hypoglycemic events (BG \<70 mg/dL and \<40 mg/dL), total daily dose of insulin, length of hospital stay, hospital complications and mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Glargine daily + Glulisine before meals
NPH twice a day + Regular insulin before meals
Clínica Médica del Hospital de Clínicas, Universidad Nacional de Asunción,
Asunción, Paraguay
Glycemic control
The primary outcome of the study is to determine differences in glycemic control as measured by mean daily BG concentration between human insulin (NPH + Regular insulin) and basal bolus therapy (glargine once daily + glulisine)
Time frame: During hospitalization, an expected average of 10 days
Hypoglycemia
Number of hypoglycemic events (\<70 mg/dl) and severe hypoglycemic events (\<40 mg/dl)
Time frame: During hospitalization, an expected average of 10 days
Insulin dose
Total daily dose of insulin
Time frame: During hospitalization, an expected average of 10 days
Length of stay
Duration of hospitalization
Time frame: During hospitalization, an expected average of 10 days
Mortality
Mortality is defined as death occurring during admission
Time frame: During hospitalization, an expected average of 10 days
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