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Completed

NCT Number: NCT02758522

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Once-daily Insulin

Drug

Patients will receive NPH insulin in a once-daily regimen. The starting dose is calculate according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the once-daily regimen will be administered subcutaneously before breakfast. Regular insulin subcutaneously wil be given in three equally divided doses before each meal.

Twice-daily Insulin

Drug

Patients receive NPH insulin in twice-daily regimen. The starting dose is calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will de fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the twice-daily regimen will be administered subcutaneously before breakfast and before dinner. Regular insulin will be given in three equally divided doses before each meal.

Triple-daily Insulin

Drug

Patients receive NPH insulin in a triple-daily regimen. The starting dose was calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the triple daily regimen will be administered subcutaneously before each meal. Regular insulin will be given in three equally divided doses before each meal.

Primary outcomes

  1. Glycemic control

    Time frame: Within the time the patient stays at hospital (2 to 14 days)

    The achievement of fasting glucose between 70-140 mg/dL and random glucose levels of <180 mg/dL

Secondary outcomes

  1. Differences in the percentage of glucoses in the hypoglycemic range

    Time frame: Within the time the patient stays at hospital (2 to 14 days)

    Hypoglycemia was defined as glucose levels of < 70 mg/dL. Severe hypoglycemia was defined as glucose levels of < 40 mg/dL or the need of assistance.

  2. Total insulin dose required during follow up and at discharge to achieve glycemic control

    Time frame: Within the time the patient stays at hospital (2 to 14 days)

  3. Differences in hospital stay days

    Time frame: Within the time the patient stays at hospital (2 to 14 days)

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 2, 2016
Registry last updated
May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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