Roche/Ipsen's taspoglutide meets Ph III primary endpoints against Lantus and placebo in patients with high BMI

Swiss drug major Roche has announced headline results from the fourth and fifth of eight T-emerge Phase III studies involved taspoglutide, a diabetes drug candidate licensed from France's Ipsen, with both studies meeting their primary endpoints.

The results of T-emerge 5 (a head to head comparison study of subcutaneous weekly taspoglutide versus insulin glargine) showed that taspoglutide demonstrated non-inferiority in HbA1c change versus insulin glargine (French drug major Sanofi-Aventis's Lantus brand). The study analysis included 1,049 patients, randomized into three arms (taspoglutide 10mg once weekly, taspoglutide 20mg once weekly and insulin glargine once daily. The average final dose of insulin glargine was 37 units.

T-emerge 7 (subcutaneous weekly taspoglutide versus placebo in patients with high body mass index [BMI] patients) showed that taspoglutide demonstrated HbA1c superiority versus placebo in patients with high BMI. The study analysis included 305 patients, randomized into two arms (taspoglutide 20 mg once weekly and placebo). In both studies taspoglutide was generally well tolerated and the most frequently reported adverse events among taspoglutide treated patients were nausea and vomiting.