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

NCT ID: NCT02278913

Last Updated: 2014-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-03-31

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.

Conditions

Hyperglycemia; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Basal Bolus (Glargine and Glulisine)

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.

Group Type: EXPERIMENTAL

Basal Bolus (Glargine and Glulisine)

Intervention Type: DRUG

Glargine daily + Glulisine before meals

Human Insulin

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

Group Type: ACTIVE_COMPARATOR

Human Insulin

Intervention Type: DRUG

NPH twice a day + Regular insulin before meals

Interventions

Basal Bolus (Glargine and Glulisine)

Glargine daily + Glulisine before meals

Intervention Type: DRUG

Human Insulin

NPH twice a day + Regular insulin before meals

Intervention Type: DRUG

Other Intervention Names

Glargine and glulisine; NPH and regular

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Nacional de Asunción

OTHER

Sponsor Role: lead

Responsible Party

Elvio Dario Bueno Colman

Jefe de Departamento de Endocrinologia y Diabetes, Hospital de Clínicas, Universidad Nacional de Asunción-Paraguay (U.N.A).

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elvio Bueno, MD

Role: PRINCIPAL_INVESTIGATOR

Universida Nacional de Asuncion

Locations

Clínica Médica del Hospital de Clínicas, Universidad Nacional de Asunción,

Asunción, , Paraguay

Countries

Paraguay

Other Identifiers

P 08/09

Identifier Type: -

Identifier Source: org_study_id