- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02278913
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
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Asuncion, Paraguay
- Clínica Médica del Hospital de Clínicas, Universidad Nacional de Asunción,
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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:
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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:
|
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)
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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
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During hospitalization, an expected average of 10 days
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Mortality
Time Frame: During hospitalization, an expected average of 10 days
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Mortality is defined as death occurring during admission
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During hospitalization, an expected average of 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P 08/09
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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