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

Universidad Nacional de Asunción

Status and phase: Completed; Phase 4

Conditions: Diabetes; Hyperglycemia

Treatments: Drug: Human Insulin; Drug: Basal Bolus (Glargine and Glulisine)

Study type: Interventional

Funder types: Other

Identifiers

NCT02278913

P 08/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Basal Bolus (Glargine and Glulisine)

Experimental group

Description:

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.

Treatment:

Drug: Basal Bolus (Glargine and Glulisine)

Human Insulin

Active Comparator group

Description:

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

Treatment:

Drug: Human Insulin