Ipsen has announced that its partner Roche has disclosed the results of the second and third of eight T-emerge phase III studies in patients with diabetes for Taspoglutide.
Taspoglutide is the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s research and developed by Roche. T-emerge 1 (subcutaneous weekly Taspoglutide versus placebo in treatment-naive patients) and T-emerge 4 (subcutaneous weekly Taspoglutide versus Sitagliptin versus placebo) both met their respective primary endpoints of change in HbA1c. In both studies Taspoglutide was generally well tolerated.
T-emerge 1 is a double-blind, randomised, placebo-controlled, 24 week study, to demonstrate superiority of Taspoglutide versus placebo in 373 treatment-naive type 2 diabetic patients. The results of T-emerge 1 showed that Taspoglutide demonstrated superior HbA1c reduction versus placebo. The study analysis included 373 patients, enrolled into three arms (Taspoglutide 10mg once weekly, Taspoglutide 10mg once weekly titrated up to 20mg once weekly after 4 weeks, and placebo).
T-emerge 4 is a head to head comparison study versus Sitagliptin (Januvia) as an add-on to Metformin. It is a double blind, active and placebo controlled, 24 week study to demonstrate the non-inferiority of Taspoglutide to Sitagliptin with a statistical test for superiority to placebo, involving 636 patients who have failed to reach their treatment targets with Metformin. T-emerge 4 showed that Taspoglutide demonstrated superior HbA1c reduction versus Sitagliptin. The study analysis included 636 patients, enrolled into four arms (Taspoglutide at doses of 10mg and 20mg, sitagliptin 100mg and placebo) in a ratio of 2:2:2:1.
Roche’s T-emerge Phase III clinical trial programme is designed as multicenter, multi-country, randomised, controlled (active or placebo), double-blind and open studies. Over 6,000 patients will be enrolled in the eight studies that comprise the T-emerge programme. Studies include two parallel Taspoglutide arms including 10mg once weekly and 10mg once weekly titrated up to 20mg once weekly after 4 weeks. Four of the eight studies have active comparators, including Exenatide, Sitagliptin, insulin Glargine and Pioglitazone.