In a euglycemic clamp study of 24 healthy obese subjects with a body mass index of 30 to 39 kg/m², single doses of Humulin® R U-500 (insulin human injection) 500 units/mL (U-500R) at 50 units (0.4-0.6 units/kg) and 100 units (0.8-1.3 units/kg) resulted in a

• mean time of onset of action <15 minutes at both doses
• mean duration of action of 21 hours with a range of 13 to 24 hours, and
• median peak insulin concentration occurring between 4 (50-unit dose) and 8 hours (100-unit dose) with a range of 0.5 to 8 hours.1

After administration of single doses of 50 and 100 units of subcutaneous U-500R to healthy obese subjects (N≥21), the mean apparent half-life was approximately 4.5 hours with a range of 1.9 to 10 hours.1

The time action characteristics reflect both prandial and basal activity, consistent with clinical experience. This effect has been attributed to the high concentration of the preparation.1

Given the time action characteristics of U-500R, it is advised to be administered subcutaneously 2 to 3 times daily approximately 30 minutes before meals.1

The dosage of U-500R should be individualized and titrated based on the

• patient’s metabolic needs
• blood glucose monitoring results, and
• glycemic control goal.1

Dosage adjustments may be needed to minimize the risk of hypoglycemia or hyperglycemia with changes in

• physical activity
• meal patterns (eg, macronutrient content or timing of food intake)
• renal or hepatic function
• medications, or
• health (ie, during acute illness.)1

HUMULIN® R U-500 (insulin human injection), for subcutaneous use, Lilly