TAMPA, FL – Because U-500 concentrated regular insulin is five times more concentrated (500 units/1 mL) than the more commonly prescribed U-100 insulin (100 units/1 mL), fewer injections are required, which may result in improved adherence and patient satisfaction.
Researchers from the James A. Haley VAMC, the University of South Florida and other Tampa institutions looked at the effectiveness and safety of the concentrated insulin in veterans with diabetes. Their report was presented at the Endo 2013 conference in San Francisco, CA.
Study authors suggested their study group was largest of U-500 regular insulin users published to date, adding that other published studies include retrospective chart reviews, while this was the first to include a case-control comparison.
The researchers used a case-control observational retrospective study using chart reviews, looking at a group of insulin resistant veterans with diabetes with similar baseline characteristics. They obtained data on subjects transitioned from U-100 to U-500 based regimens, analyzing it six months prior to change in treatment and for 12 months after with the U-500 group.
Of 155 patients meeting inclusion criteria, 72 were in the U-500 group, with 83 in the control group maintained on U-100 and monitored for 18 months. Hemoglobin A1C, weight, BMI, lipids, kidney function, self-reported patient satisfaction, treatment adherence, and severe hypoglycemia episodes were compared.
The researchers found no significant changes in BMI [0.86 (3.56) vs. 1.03 (2.41), p = 0.56], hemoglobin A1c [-0.23 (1.29) vs. -0.36 (1.49), p = 0.53], or LDL [-1.67 (28.4) vs. -7.32 (29.97), p = 0.44], respectively, when comparing pre- and post-interventional data between the U-100 and U-500 groups. There also were no significant changes in total cholesterol, HDL, triglycerides or creatinine.
While the majority of U-500 patients expressed satisfaction and good adherence with therapy, they did suffer a higher incidence of severe hypoglycemia, according to the report.
“U-500 regular insulin offers type 2 diabetic patients with high insulin resistance an alternative that may lead to improved adherence and satisfaction,” the researchers wrote. “When compared to controls, there was no difference in clinical outcomes, including hemoglobin A1C changes over time, despite using a lower volume of insulin and fewer injections.”
They cautioned, however, that “patients on U-500 need to be carefully monitored due to significant risks of severe hypoglycemia.”
- Villafranca III A, et al. (2013, June). U-500 Insulin Use in Type 2 Diabetes Mellitus Patients with High Insulin Resistance. Poster session presented at the Endo 2013 meeting, San Francisco, CA.