Initiation of human regular U-500 insulin use is associated with improved glycemic control: a real-world US cohort study

Abstract

AimDescribe the characteristics of patients initiating human regular U-500 insulin (U-500R) and their subsequent glycemic control in a real-world setting.MethodsUS Humedica electronic health record system data (July 2007–September 2011) were used to identify patients with diabetes aged ≥18 years with ≥1 records for U-500R prescriptions, 6 months of preindex data, 12 months following first use of U-500R, and at least one glycated hemoglobin (HbA1c) value in both preindex and postindex periods. Paired t tests were used to measure the change in HbA1c from preindex to postindex periods (last or most recent values) and hypoglycemia.ResultsAmong patients initiating U-500R (N=445), 96.9% had type 2 diabetes with mean age 57 years and mean body mass index 40.4 kg/m2. Postindex prescriptions were written for U-500R alone (47.0%, group A) and concomitant U-500R/U-100 insulins (53.0%, group B). Concomitant oral antihyperglycemic agents (AHAs) and non-insulin injectable AHAs were used by 43.4% and 14.6% of patients, respectively. Following initiation of U-500R, mean HbA1c improved 0.68% in all patients (p<0.0001 compared with baseline), but the decrease in HbA1c did not differ significantly between groups (A: 0.78%; B: 0.60%). Overall, hypoglycemic events, largely captured in the outpatient setting, increased in incidence from 6.7% to 11.9% (p≤0.0001) and from 0.23 to 0.39 events/patient/year, an increase of 0.16 (p=0.003), from preindex to postindex.ConclusionsThis real-world outcomes analysis demonstrates that U-500R initiation is associated with a clinically meaningful improvement in glycemic control over the subsequent 12-month period with modest increase in incidence and rate of hypoglycemia.

Concentrated insulins in current clinical practice

“…In addition, people with severe insulin resistance may need to inject > 100 units or 1 mL of Reg-U100 insulin at a time [10]. When switching these people from U-100 insulin regimens to U-500 insulin, the reduced volume of dosing with the U-500 concentration allowed treatment of people with severely insulin-resistant diabetes with 2 to 3 injections daily compared to up to 10 injections a day with U-100 insulins [11,12]. Reg-U500 and the newer concentrated insulin preparations now available (Table 1), may provide potential advantages including decreased number of injections, decreased pain, less frequent pen changes, ability to deliver larger doses, improved pen mechanics, and enhancements of continuous subcutaneous insulin infusion.…”

Delayed Response to U-500 Regular Insulin

“…In addition to the inconvenience to patients of having to take an increased number of injections, insulin absorption from large injectate volumes is impaired (3–5). For these reasons, increasing numbers of severely insulin-resistant patients, whose insulin resistance is most often due to obesity, are being treated with U-500 regular insulin (6).…”

Advances in Diabetes Pharmacotherapy: An Update for the Emergency Provider

“…More recently, other insulins have become available in concentrated forms and in insulin pen formulations, including aspart (U-200), glargine (U-300), and degludec (U-200) (6,11). Concentrated insulins have several therapeutic benefits, including smaller and fewer injections, which may lead to improved adherence and better glycemic control (12,13). At the same time, there is a greater potential for confusion and dosing errors that may lead to hypoglycemia (13).…”