Diabetes, Hyperglycemia
Conditions
Keywords
inpatient, hospital, randomized trial, diabetes, analogs, human insulin
Brief summary
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.
Detailed description
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.
Interventions
DRUGBasal Bolus (Glargine and Glulisine)
Glargine daily + Glulisine before meals
DRUGHuman Insulin
NPH twice a day + Regular insulin before meals
Sponsors
Universidad Nacional de Asunción
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * History of type 2 diabetes \> 1 month * Treatment with diet alone, any combination of oral antidiabetic agents, and/or insulin prior to admission * Absence of diabetic ketoacidosis
Exclusion criteria
* No history of diabetes * Subjects expected to undergo surgery during the hospitalization course * Clinically relevant hepatic disease * Impaired renal function (serum creatinine ≥ 3.0 mg/dL) * Pregnancy * Any mental condition rendering the subject unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | During hospitalization, an expected average of 10 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia | During hospitalization, an expected average of 10 days | Number of hypoglycemic events (\<70 mg/dl) and severe hypoglycemic events (\<40 mg/dl) |
| Insulin dose | During hospitalization, an expected average of 10 days | Total daily dose of insulin |
| Length of stay | During hospitalization, an expected average of 10 days | Duration of hospitalization |
| Mortality | During hospitalization, an expected average of 10 days | Mortality is defined as death occurring during admission |
Countries
Paraguay
Outcome results
None listed