This article is more than 5 years old. Information may no longer be current.
Subcutaneous exenatide delivery improves glycemic control in high baseline HbA1c
Click Here to Manage Email Alerts
The GLP-1 receptor agonist exenatide delivered subcutaneously through an osmotic mini-pump significantly improved glycemic control in adults with uncontrolled type 2 diabetes and high baseline HbA1c, according to findings published in Diabetes Care.
The drug and device combination, ITCA 650 (Intarcia Therapeutics), is currently in development for the treatment of type 2 diabetes, according to study background.
“ITCA 650 provides an innovative method of delivering exenatide (AstraZeneca), which has the potential to address important and prevalent unmet medical needs of patients with [type 2 diabetes] by improving and sustaining glycemic control over time,” the researchers wrote.
Robert R. Henry, MD, of the VA San Diego Healthcare System and the University of California, San Diego, and colleagues evaluated data from the FREEDOM-1 High Baseline (HBL) study on 60 adults (mean age, 51.9 years; 56.7% men; 80% white) with poorly controlled type 2 diabetes and high HbA1c (mean HbA1c, 10.8%; mean diabetes duration, 8.5 years) treated with ITCA 650 20 µg per day for 13 weeks, then 60 µg per day for 26 weeks to determine the change in HbA1c at week 39.
Participants of the current study were excluded from the FREEDOM-1 study because of their high baseline HbA1c. Endocrine Today previously reported on results from the study that revealed that ITCA 650 significantly reduced HbA1c and weight compared with placebo in adults with type 2 diabetes inadequately controlled with oral antidiabetes medications.
The mean change in HbA1c was a reduction of 2.8% in all participants (P < .001 vs. baseline). Twenty-five percent of participants achieved HbA1c less than 7% and 18.6% achieved HbA1c of 6.5% or less at week 39. Seventy-three percent of participants had a reduction in HbA1c of at least 2%, and 46% had a reduction of at least 3%.
At least one adverse event was reported by 86.7% of participants. Six serious adverse events were reported among four participants, but researchers did not consider them to be related to ITCA 650 therapy. The most commonly reported adverse events were gastrointestinal disorders.
“Placement of ITCA 650 is highly effective in reducing daylong plasma glucose, easy to inset and remove in a short office visit and assures 100% adherence to exenatide therapy,” Henry told Endocrine Today. “Research moving forward will need to compare benefits of ITCA 650 alone and in addition to over anti-hyperglycemic medications. We will also need to perform a cardiovascular trial to assure CV safety and possible benefits of ITCA 650.” – by Amber Cox
For more information:
Robert R. Henry, MD, can be reached at rrhenry@outlook.com.
Disclosures: The study was funded by Intarcia Therapeutics Inc. Henry reports he receives grants from AstraReal, AstraZeneca, Hitachi, Eli Lilly, Lexicon, Novo Nordisk and Vitacyte; has served on advisory boards and acted as a consultant for AstraZeneca, Intarcia, Johnson & Johnson/Janssen and Sanofi-Aventis; has served on scientific advisory boards for Boehringer Ingelheim, Elcelyx and Sanofi; and has acted as a consultant for Alere and Ionis. Please see the study for all other authors’ relevant financial disclosures.
Click Here to Manage Email Alerts