As part of a 24-week phase 2 study to select a specific dosing regimen for a phase 3 clinical program, researchers found that higher doses of injection-free exenatide were well-tolerated and reduced HbA1c levels.
Researchers randomly assigned 155 patients with type 2 diabetes and a mean baseline HbA1c of 8% to injection-free exenatide (ITCA 650, Intarcia Therapeutics, Inc.) at 20 mcg (n=51), 40 mcg (n=51), or twice daily injectable exenatide (Byetta, Amylin) at 5 mcg titrated to 10 mcg (n=53) for 12 weeks.
ITCA 650 provides continuous subcutaneous administration for 3, 6, or 12 months from a single placement.
After 12 weeks, patients who received ITCA 650 were randomly assigned to either continue their dose or increase to a higher dose. According to researchers, half of the patients originally assigned to 20 mcg increased to 60 mcg, and half of the patients originally assigned to 40 mcg increased to 80 mcg.
Additionally, patients randomly assigned to exenatide injections were assigned 1:1 to ITCA 650 at 40 mcg or 60 mcg.
The researchers found that chronic administration of the higher doses of ITCA 650 (at 40 mcg, 60 mcg, or 80 mcg) saw greater improvements in HbA1c, fasting plasma glucose, postprandial glucose and body weight, compared with the 20 mcg dose. According to data, the 40 mcg and 60 mcg doses of ITCA 650 were better tolerated than the 80 mcg doses and HbA1c levels were lower in patients who received 60 mcg compared with 40 mcg.
Overall, 61.1% of patients treated with 60 mcg whose baseline HbA1c was >8%, achieved a target HbA1c of <7%. Of those patients, 44.4% achieved HbA1c levels ≤6.5%. However, 28.6% of patients on 40 mcg achieved <7% HbA1c and no patients achieved ≤6.5%, according to data.
These findings will be used to further examine the ITCA 650 global phase 3 clinical program, researchers said.
For more information:
Henry RR. #109. Presented at: the European Association for the Study of Diabetes 48th Annual Meeting; October 1-5, 2012; Berlin.