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

NCT02278913 | Completed Phase 4

• 1 other identifier: P 08/09
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Diabetes

Keywords

inpatient; hospital; randomized trial; diabetes; analogs; human insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hypoglycemia

  During hospitalization, an expected average of 10 days

• Insulin dose

  During hospitalization, an expected average of 10 days

• Length of stay

  During hospitalization, an expected average of 10 days

• Mortality

  During hospitalization, an expected average of 10 days

Study Arms (2)

Basal Bolus (Glargine and Glulisine)

EXPERIMENTAL

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)

Human Insulin

ACTIVE COMPARATOR

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

Interventions

Basal Bolus (Glargine and Glulisine) DRUG

Glargine daily + Glulisine before meals

Also known as: Glargine and glulisine

Basal Bolus (Glargine and Glulisine)

Human Insulin DRUG

NPH twice a day + Regular insulin before meals

Also known as: NPH and regular

Human Insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional de Asunción: lead

Study Sites (1)

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

Asunción, Paraguay

Location

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus; Insulin Resistance

Interventions

Insulin Glargine; Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Elvio Bueno, MD

  Universida Nacional de Asuncion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jefe de Departamento de Endocrinologia y Diabetes, Hospital de Clínicas, Universidad Nacional de Asunción-Paraguay (U.N.A).

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: October 30, 2014
• Study Start: April 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: March 1, 2011
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

PA (1)