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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278913
• Other study ID #: P 08/09
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2014
• Last updated: October 29, 2014
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: October 2014
• Source: Universidad Nacional de Asunción
• Contact: n/a
• Is FDA regulated: No
• Health authority: Paraguay: Ministerio de Salud Pública y Bienestar Social
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: March 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Intervention

Drug:
• Basal Bolus (Glargine and Glulisine)
Glargine daily + Glulisine before meals
• Human Insulin
NPH twice a day + Regular insulin before meals

Locations

Country	Name	City	State
Paraguay	Clínica Médica del Hospital de Clínicas, Universidad Nacional de Asunción,	Asuncion

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Asunción

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
Secondary	Hypoglycemia	Number of hypoglycemic events (<70 mg/dl) and severe hypoglycemic events (<40 mg/dl)	During hospitalization, an expected average of 10 days	Yes
Secondary	Insulin dose	Total daily dose of insulin	During hospitalization, an expected average of 10 days	No
Secondary	Length of stay	Duration of hospitalization	During hospitalization, an expected average of 10 days	No
Secondary	Mortality	Mortality is defined as death occurring during admission	During hospitalization, an expected average of 10 days	Yes