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

Phase 4

Completed

• Conditions: Diabetes Mellitus; Hyperglycemia
• Interventions: Drug: Twice-daily Insulin; Drug: Triple-daily Insulin; Drug: Once-daily Insulin

• Registration Number: NCT02758522
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-04
• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-04-28
• Last Update Submitted: 2016-04-28
• Study First Posted: 2016-05-02
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Twice-daily insulin	Twice-daily Insulin	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).
Triple-daily insulin	Triple-daily Insulin	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).
Once-daily insulin	Once-daily Insulin	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).

Primary Outcome Measures

Name	Time	Method
Glycemic control	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 Outcome Measures

Name	Time	Method
Differences in the percentage of glucoses in the hypoglycemic range	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.
Total insulin dose required during follow up and at discharge to achieve glycemic control	Within the time the patient stays at hospital (2 to 14 days)
Differences in hospital stay days	Within the time the patient stays at hospital (2 to 14 days)