| Trial ID: | L4584 |
| Source ID: | NCT02278913
|
| Associated Drug: |
Basal Bolus (Glargine And Glulisine)
|
| Title: |
Basal Bolus Versus Human Insulin in Hospitalized Patients With Diabetes in Paraguay
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperglycemia|Diabetes
|
| Interventions: |
DRUG: Basal Bolus (Glargine and Glulisine)|DRUG: Human Insulin
|
| Outcome Measures: |
Primary: 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), During hospitalization, an expected average of 10 days | Secondary: Hypoglycemia, Number of hypoglycemic events (\<70 mg/dl) and severe hypoglycemic events (\<40 mg/dl), During hospitalization, an expected average of 10 days|Insulin dose, Total daily dose of insulin, During hospitalization, an expected average of 10 days|Length of stay, Duration of hospitalization, During hospitalization, an expected average of 10 days|Mortality, Mortality is defined as death occurring during admission, During hospitalization, an expected average of 10 days
|
| Sponsor/Collaborators: |
Sponsor: Universidad Nacional de Asunción
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
134
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-04
|
| Completion Date: |
2011-03
|
| Results First Posted: |
|
| Last Update Posted: |
2014-10-30
|
| Locations: |
Clínica Médica del Hospital de Clínicas, Universidad Nacional de Asunción,, Asuncion, Paraguay
|
| URL: |
https://clinicaltrials.gov/show/NCT02278913
|
