Basal Bolus Versus Human Insulin in Hospitalized Patients With Diabetes in Paraguay

Study Overview
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Brief Summary
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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
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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.

Official Title
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Basal Bolus Regimen With Insulin Analogs Versus Human Insulin in Medical Patients With Type 2 Diabetes: A Randomized Controlled Trial in Paraguay

Conditions
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Hyperglycemia, Diabetes

Intervention / Treatment
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* Drug: Basal Bolus (Glargine and Glulisine)
* Drug: Human Insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basal Bolus (Glargine and Glulisine)<br>Basal bolus: with Insulin analogs (glargine and glulisine), 50% of total daily dose as glargine given before breakfast and 50% as glulisine insulin given in three equally divided doses before each meal. | Drug: Basal Bolus (Glargine and Glulisine)<br>* Glargine daily + Glulisine before meals<br>* Other names: Glargine and glulisine;|
| Active Comparator: Human Insulin<br>Human insulin: NPH and regular insulin: 2/3 of total daily dose as NPH and 1/3 as regular insulin. NPH insulin dose given as 2/3 in the morning before breakfast and 1/3 before dinner. Regular insulin given in three equally divided doses before each meal | Drug: Human Insulin<br>* NPH twice a day + Regular insulin before meals<br>* Other names: NPH and regular;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inpatient, hospital, randomized trial, diabetes, analogs, human insulin