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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278913
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Elvio Dario Bueno Colman, Universidad Nacional de Asunción

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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Diabetes Drug: Basal Bolus (Glargine and Glulisine) Drug: Human Insulin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Basal Bolus Regimen With Insulin Analogs Versus Human Insulin in Medical Patients With Type 2 Diabetes: A Randomized Controlled Trial in Paraguay
Study Start Date : April 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. Insulin dose [ Time Frame: During hospitalization, an expected average of 10 days ]
    Total daily dose of insulin

  3. Length of stay [ Time Frame: During hospitalization, an expected average of 10 days ]
    Duration of hospitalization

  4. Mortality [ Time Frame: During hospitalization, an expected average of 10 days ]
    Mortality is defined as death occurring during admission



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278913


Locations
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Paraguay
Clínica Médica del Hospital de Clínicas, Universidad Nacional de Asunción,
Asuncion, Paraguay
Sponsors and Collaborators
Universidad Nacional de Asunción
Investigators
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Principal Investigator: Elvio Bueno, MD Universida Nacional de Asuncion

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Responsible Party: Elvio Dario Bueno Colman, Jefe de Departamento de Endocrinologia y Diabetes, Hospital de Clínicas, Universidad Nacional de Asunción-Paraguay (U.N.A)., Universidad Nacional de Asunción
ClinicalTrials.gov Identifier: NCT02278913    
Other Study ID Numbers: P 08/09
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014
Keywords provided by Elvio Dario Bueno Colman, Universidad Nacional de Asunción:
inpatient
hospital
randomized trial
diabetes
analogs
human insulin
Additional relevant MeSH terms:
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Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs