NEW YORK (Reuters Health) – The glucagon-like peptide 1 analog taspoglutide administered subcutaneously once weekly improves glycemic control and reduces body weight in drug-naive patients with type 2 diabetes, according to the results of a randomized, double-blind, placebo-controlled phase 3 study reported in Diabetes Care online February 1.
“Taspoglutide monotherapy was generally well tolerated; the most frequently reported AEs were nausea and vomiting,” Dr. Itamar Raz, at Hadassah Ein Kerem Hospital, Jerusalem, Israel, and colleagues report.
However, the paper includes this explanatory note about the development of taspogluide: “In September 2010, Roche decided to stop dosing patients in the taspoglutide phase 3 trials because higher than expected discontinuation rates of taspoglutide-treated patients were observed, mainly due to gastrointestinal tolerability, and as a result of the implementation of the risk mitigation plan to address serious hypersensitivity reactions.”
It continues: “Since this time, Roche has worked on the root cause analysis and on the modified taspoglutide formulations with the input of Ipsen. After further analysis, Roche has now made the decision to stop the development of taspoglutide and to return the product to the originator, Ipsen, which is currently pursuing further investigations.”
For the current study, the researchers randomized 373 patients with type 2 diabetes who had not previously been treated with antidiabetic medication to receive weekly subcutaneous injections of 10 mg or 20 mg taspoglutide or placebo for 24 weeks.
Changes in HbA1c from baseline in the three arms were -1.01%, -1.18% and -0.09%, respectively (p<0.0001 for both doses vs placebo), the report indicates. “Notable findings included a mean reduction in HbA1c of nearly 1.2% in patients with a mean baseline of 7.7% treated with taspoglutide 20 mg,” the authors comment.
In addition, bodyweight decreased in all three groups, by1.45 kg, 2.25 kg, and 1.23 kg, respectively.
GI complaints were reported by 37.9% of subjects in the 10-mg group, 45.0% of those given 20 mg, and 10.6% of the placebo group, according to the report. Rates of withdrawal due to adverse events were 11.2%, 13.2% and 3.3% in the three ams, respectively.
“In summary, once-weekly taspoglutide given as monotherapy was efficacious and generally well tolerated in patients with type 2 diabetes naive to treatment with antidiabetic agents,” Dr. Raz and colleagues conclude.
So far, Ipsen has not responded to a request to clarify the status of taspoglutide.
