Humulin R U-500 human insulin monotherapy delivers a dual action, providing the properties of both basal and mealtime coverage when dosed as directed
U-500 insulin monotherapy may reduce the injection burden*3,4
In patients who need more than 200 units a day, U-500 is usually injected 2 or 3 times per day, compared with a median of 5‡ times for other insulin regimens.§1
Lower the daily insulin volume
80% less liquid volume than U-100 insulin delivers the same number of daily units.
Demonstrated in the Humulin R U-500 Initiation Trial
A clinical framework for transitioning patients from U-100 insulin to U-5001
How starting doses were determined in the U-500 Initiation Trial:
• If A1C was >8% at Week -4 and mean self-monitored plasma glucose (SMPG) ≥183 mg/dL in the 7 days before Week 0, then the starting total daily dose (TDD) of U-500 was 100% of the final U-100 TDD
• If A1C was ≤8% at Week -4 or mean SMPG <183 mg/dL in the 7 days before Week 0, then the starting TDD of U-500 was 80% of the final U-100 TDD (20% reduction)
24-week, open-label, randomized trial to compare the efficacy and safety of 2 dosing regimens (TID, n=162 vs BID, n=163) for U-500 insulin replacing high-dose U-100 insulin (>200 units per day) with or without oral antihyperglycemic drugs in adult patients with uncontrolled type 2 diabetes. These regimens were found to be equivalent for A1C reduction over 24 weeks, and both were found to be efficacious1.
• Treat-to-target dosing algorithms titrated TID or BID regimens to achieve fasting and pre-meal SMPG 71-130 mg/dL
• Both doses of the BID regimen were titrated; only 2 of 3 TID doses were titrated (those most needing adjustment)
• Dose reductions were prioritized over dose increases for hypoglycemia
• U-500 dosing was recommended 30 minutes before meals using a U-100 insulin syringe
• Patients checked their blood glucose before each meal and at bedtime daily, and at 3 AM if they had increased their dose in the last 48 hours
Select Safety Information for Humulin R U-500
• Hypoglycemia: Hypoglycemia is the most common adverse reaction associated with insulin, including Humulin R U-500. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Severe hypoglycemia may develop as long as 18 to 24 hours after an injection of Humulin R U-500. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important, such as driving or operating other machinery.