Clinical trial NCT02278913: Basal Bolus Versus Human Insulin in Hospitalized Patients With Diabetes in Paraguay
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperglycemia
Diabetes
Keywords: inpatient
hospital
randomized trial
diabetes
analogs
human insulin
Lead sponsor: Universidad Nacional de Asunción
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Glycemic control
timeFrame: During hospitalization, an expected average of 10 days
Secondary outcomes:
measure: Hypoglycemia
timeFrame: During hospitalization, an expected average of 10 days
measure: Insulin dose
timeFrame: During hospitalization, an expected average of 10 days
measure: Length of stay
timeFrame: During hospitalization, an expected average of 10 days
measure: Mortality
timeFrame: During hospitalization, an expected average of 10 days
Other outcomes:
Locations:
city: Asuncion
country: Paraguay
facility: Clínica Médica del Hospital de Clínicas, Universidad Nacional de Asunción,
Study officials:
affiliation: Universida Nacional de Asuncion
name: Elvio Bueno, MD
role: PRINCIPAL_INVESTIGATOR
References: