NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia; Diabetes Mellitus

Treatments: Drug: Twice-daily Insulin; Drug: Triple-daily Insulin; Drug: Once-daily Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02758522

MI13-005

Details and patient eligibility

About

The objective of this study is to compare the therapeutic efficacy of three regimens of insulin NPH/fast for optimal glycemic control in non-critical hospitalized patients.

Full description

Patients will be randomly assigned to one of the three treatment regimens. Also, the use of oral antidiabetic drugs would be suspended during their stay at the hospital.

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted to medical services
• Persistent blood glucose level > 140 mg/dL
• With an expected stay ≥ 48 hours

Exclusion criteria

• Subjects with type 1 diabetes mellitus
• Parenteral nutrition
• Glucose levels ≥ 400 mg/dL at screening
• Diabetic ketoacidosis or non-ketosis hyperosmolar state
• Clinically relevant hepatic disease
• Glomerular filtration rate ≤ 30 ml/min
• Pregnancy
• Terminal disease
• Inability to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Once-daily insulin

Active Comparator group

Description:

60% of total dose of insulin as NPH insulin in the once-daily regimen was administered subcutaneously before breakfast. Also, 40% in rapid insulin before meals (every 8 hours).

Treatment:

Drug: Once-daily Insulin

Twice-daily insulin

Active Comparator group

Description:

60% of total dose of insulin as NPH insulin in the twice-daily regimen it was given before breakfast and before dinner. Also, 40% in rapid insulin before meals (every 8 hours).

Treatment:

Drug: Twice-daily Insulin

Triple-daily insulin

Active Comparator group

Description:

60% of total dose of insulin as NPH insulin in the triple daily regimen it was administered before each meal. Also, 40% in rapid insulin before meals (every 8 hours).

Treatment:

Drug: Triple-daily Insulin