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

Phase 4

Completed

• Conditions: Diabetes; Hyperglycemia
• Interventions: Drug: Basal Bolus (Glargine and Glulisine); Drug: Human Insulin

• Registration Number: NCT02278913
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-04
• Primary Completion: 2010-04
• Study Completion: 2011-03
• Status Verified: 2014-10
• Study First Submitted: 2014-10-24
• Study First Submitted QC: 2014-10-29
• Last Update Submitted: 2014-10-29
• Study First Posted: 2014-10-30
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Basal Bolus (Glargine and Glulisine)	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.
Human Insulin	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

Primary Outcome Measures

Name	Time	Method
Glycemic control	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

Name	Time	Method
Insulin dose	During hospitalization, an expected average of 10 days	Total daily dose of insulin
Length of stay	During hospitalization, an expected average of 10 days	Duration of hospitalization
Mortality	During hospitalization, an expected average of 10 days	Mortality is defined as death occurring during admission
Hypoglycemia	During hospitalization, an expected average of 10 days	Number of hypoglycemic events (\<70 mg/dl) and severe hypoglycemic events (\<40 mg/dl)

Trial Locations

Locations (1)

Clínica Médica del Hospital de Clínicas, Universidad Nacional de Asunción,; 🇵🇾 Asuncion, Paraguay