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%.

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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.

"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%."

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.

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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.

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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.