Original ArticleA Prospective Trial of U500 Insulin Delivered by Omnipod in Patients With Type 2 Diabetes Mellitus and Severe Insulin Resistance
Section snippets
INTRODUCTION
The global epidemics of obesity and type 2 diabetes mellitus are driving the need to deliver ever-increasing insulin doses to a growing population of patients with type 2 diabetes and severe insulin resistance (absolute insulin requirement of more than 200 units of insulin per day, or more than the usual insulin requirement of approximately 1 to 1.2 units of insulin per kilogram of body weight per day in patients with type 2 diabetes). Delivering high doses of U100 insulin or insulin analogues
RESARCH DESIGN AND METHODS
In this prospective, 1-year, proof-of-concept trial, patients with insulin-requiring type 2 diabetes who had a hemoglobin A1c (HbA1c) level of 7.0% or higher and severe insulin resistance (average insulin requirement, 1.74 units of insulin per kilogram each day; range, 1.4 to 2.64 units of insulin per kilogram [average insulin dose, 196.4 units daily]) were identified at routine office visits at Mountain Diabetes and Endocrine Center in Asheville, North Carolina, between December 2007 and
RESULTS
Twenty-one patients (14 men and 7 women) ranging in age from 32 to 72 years were enrolled in the study. The baseline characteristics of the study cohort are summarized in Table 1. Twelve patients used oral insulin sensitizers (metformin [n = 10]), a thiazolidinedione (n = 1), or both metformin and a thiazolidinedione (n = 1) along with highdose insulin therapy. Eighteen patients initially used MDI; the remaining 3 patients initially used CSII. Twenty of 21 patients completed the 12-month study.
DISCUSSION
This prospective pilot study was designed to test the effectiveness and safety of U500 insulin in CSII delivered via the Omnipod insulin delivery system to a group of patients with uncontrolled type 2 diabetes and severe insulin resistance with extremely high insulin requirements. These high insulin requirements had resulted in chronic poor glycemic control due to a combination of poor absorption of high volumes of injected U100 insulin and poor adherence to an uncomfortable and ineffective
CONCLUSION
Our findings indicate that patients with uncontrolled type 2 diabetes and severe insulin resistance with insulin requirements exceeding 1.4 U/kg per day on U100-based intensive insulin regimens may improve glycemic control by switching therapy to CSII using U500 regular insulin. Therapy with U500 insulin by CSII was associated with weight gain in most, but not all, patients. The Omnipod was a highly acceptable method of insulin delivery for use with U500 insulin in this cohort. Presently, U500
DISCLOSURE
Dr. Wendy S. Lane and Dr. Stephen L. Weinrib are on the speaker’s bureau for Eli Lilly. Dr. Jonathan M. Rappaport and Ms. Therese Przestrzelski have no multiplicity of interest to disclose.
ACKNOWLEDGMENT
This research was made possible through grants from Insulet Corporation and Eli Lilly, Inc. The authors wish to thank Chris Hale, MA, CRC, for excellent technical assistance with this manuscript and for performing the statistical analyses and Jay Skyler, MD, for his support and encouragement.
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2017, AACE Clinical Case ReportsCitation Excerpt :It has been shown that U-500 regular insulin can control hyperglycemia in obese patients with severe insulin resistance requiring >200 units/day (11). Continuous subcutaneous U-500 insulin delivery is also effective in type 2 diabetes with severe insulin resistance or lipodystrophy (12–14). Recombinant human IGF-I (rhIGF-I), on the other hand, is effective in the treatment of insulin resistance related to receptorpathy (15).