Intarcia Therapeutics has started enrolling patients in the first of four Phase III trials, Freedom-1, evaluating the safety and efficacy of ITCA 650 in type 2 diabetes (T2D).
The Freedom-1 study will involve T2D patients whose HbA1c is not controlled on zero to three oral anti-diabetes drugs, and whose HbA1c measures between 7.5% and 10.0%.
Intarcia vice president and chief medical officer Dr Michelle Baron said; "Our goal is to demonstrate that ITCA 650 can successfully deliver up to a full year of treatment from a single placement of the mini-pump – a potential breakthrough in addressing a huge unmet need in this chronic disease."
The placebo-controlled, double-blind study will randomise 450 patients into three groups in a 1:1:1 ratio, evaluating ITCA 650 40mcg/d and ITCA 650 60mcg/d versus placebo.
Active arm subjects will be treated with three-month devices for the first 13 weeks, which deliver an initial dose of 20mcg/d, followed by six-month ITCA 650 at doses of 40mcg/d or 60mcg/d.
The change in HbA1c at nine months is the primary endpoint, while secondary endpoints are changes in weight, FPG, PPG, tolerability and other measures of safety and efficacy.
Intarcia chairman, president and CEO Kurt Graves said; "We firmly believe that a once-yearly GLP-1 therapy that virtually ensures long-term compliance can do extremely well in any real-world outcomes comparative trials and in the payor-driven and outcomes-focused healthcare environment of the future."
Quintiles, Intarcia’s strategic partner for the Freedom clinical programme, will implement of all four trials.
At the same time, Intarcia will conduct an open-label study, Freedom-1 HBL (high baseline), in patients meeting all eligibility criteria for Freedom-1, but whose baseline HbA1c is greater than 10%.
All patients will be treated for the first three months with ITCA 650 20mcg/d and with ITCA 650 60mcg/d for the next six months.