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

October 29, 2014 updated by: Elvio Dario Bueno Colman, Universidad Nacional de Asunción

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Asuncion, Paraguay
        • Clínica Médica del Hospital de Clínicas, Universidad Nacional de Asunción,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Glargine daily + Glulisine before meals
Other Names:
  • Glargine and glulisine
Active Comparator: 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
NPH twice a day + Regular insulin before meals
Other Names:
  • NPH and regular

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: During hospitalization, an expected average of 10 days
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
Time Frame: During hospitalization, an expected average of 10 days
Number of hypoglycemic events (<70 mg/dl) and severe hypoglycemic events (<40 mg/dl)
During hospitalization, an expected average of 10 days
Insulin dose
Time Frame: During hospitalization, an expected average of 10 days
Total daily dose of insulin
During hospitalization, an expected average of 10 days
Length of stay
Time Frame: During hospitalization, an expected average of 10 days
Duration of hospitalization
During hospitalization, an expected average of 10 days
Mortality
Time Frame: During hospitalization, an expected average of 10 days
Mortality is defined as death occurring during admission
During hospitalization, an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elvio Bueno, MD, Universida Nacional de Asuncion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Estimate)

October 30, 2014

Last Update Submitted That Met QC Criteria

October 29, 2014

Last Verified

October 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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