Hospital Management of Hyperglycemia Study of Insulin Glargine Plus Insulin Lispro Versus Human Regular Insulin

Randomized Clinical Trial of Subcutaneous Analog Basal Bolus Therapy Versus Sliding Scale Human Regular Insulin in the Hospital Management of Hyperglycemia in Non-Critically Ill Patients Without Known History of Diabetes: The HMH Trial

The purpose of this study is to compare the use of insulin glargine plus insulin lispro to human regular insulin for treatment of hyperglycemia in the hospital setting in patients without known prior history of diabetes.

This study involves a comparison of 2 methods for administering subcutaneous insulin therapy to non-critically ill adult patients with hyperglycemia and without known history of diabetes who are admitted to non-intensive care unit (ICU) general medical hospital services. Basal-bolus therapy, considered the gold standard for glucose control in patients with known diabetes, will be compared with sliding scale insulin, a commonly used method of glucose control (prevailing standard practice) in hospitalized patients. In this study, basal-bolus therapy will consist of once-daily glargine plus lispro 3 to 4 times daily adjusted to achieve pre-meal capillary plasma glucose <140 milligrams per deciliter (mg/dL) and bedtime capillary plasma glucose <180 mg/dL for patients who are eating [predose plasma glucose <140 mg/dL for patients with nil per os (NPO) orders]; sliding scale insulin will be administered using human regular insulin 4 times daily as needed adjusted to achieve predose capillary plasma glucose target <140 mg/dL in patients who are eating or have NPO orders.

Major Inclusion Criteria:

• No known history of diabetes
• Admission or pre-entry plasma glucose (PG) level between 140 and 400 mg/dL
• Non-critically ill and admitted to acute care medical services
• Have a body mass index greater than or equal to 18.5 kg/m^2 and less than or equal to 45 kilograms per square meter (kg/m^2)

Major Exclusion Criteria:

• Received any insulin/analog therapy for longer than 108 hours prior to study entry or intermediate- or long-acting insulin/analogs (neutral protamine Hagedorn, detemir, or glargine) in the 24 hours prior to randomization or any intravenous insulin therapy prior to randomization
• Laboratory evidence of diabetic ketoacidosis for patients with pre-randomization PG greater than 250 mg/dL
• Have taken any oral or injectable antihyperglycemic medications other than insulin within 3 months prior to study entry
• Have acute critical illness or are expected to require admission to an ICU or equivalent or be treated with glucocorticoid therapy during the hospital study period
• Expected hospitalization less than 24 hours post-randomization