Intarcia’s Phase III diabetes data shows sustained blood sugar control

USA-based Intarcia Therapeutics has announced successful top-line results from two of its four Phase III clinical trials for ITCA 650 (exenatide, delivered continuously once or twice yearly through a matchstick-sized, subcutaneous osmotic mini-pump).

The first trial, FREEDOM-1, was a placebo-controlled, double-blind Phase III clinical study that tested the efficacy and safety of ITCA 650 in patients with type 2 diabetes against placebo. This study demonstrated ITCA 650 to be significantly superior to placebo for both 40mcg and 60mcg doses, and met all its clinical endpoints. Also, pre-specified sub-group analyses showed substantial improvement in hyperglycemia across a wide spectrum of patients and background medications.

The second trial, FREEDOM-1 HBL (High Baseline), was an open-label Phase III clinical trial in type 2 diabetes patients with very high baseline HbA1c levels between 10%-12%. The 39-week (9-month) results showed a sustained reduction of 3.4% in HbA1c among these poorly controlled patients. The HBL study also showed the ability of a 39-week therapy with ITCA 650 to bring 25% of these patients, many uncontrolled on multi-drug therapy, to their HbA1c goal of <7%.