Once-weekly taspoglutide works better than sitagliptin (Januvia) in type 2 diabetes: Roche

Taspoglutide, an once-weekly anti-diabetic drug by Roche, has been found superior to the currently marketed drug sitagliptin (Januvia).

Taspoglutide is found to be providing potent and durable glucose control in comparison with sitagliptin (Januvia), another drug from the same class of compounds, by Merck.

Roche has announced 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.

Roche licensed taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market taspoglutide, except in Japan. Taspoglutide rights in Japan are shared with Teijin.

T-emerge 1 (subcutaneous weekly taspoglutide versus placebo in treatment-naïve patients) and T-emerge 4 (subcutaneous weekly taspoglutide versus sitagliptin versus placebo) both met their respective primary endpoints of change in HbA1c, Roche announced in a press statement.

Taspoglutide was generally well tolerated, in both studies. The most frequently reported adverse events among taspoglutide treated patients were nausea and vomiting.

Taspoglutide is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation. GLP-1 analogues stimulate insulin secretion and suppress glucagon secretion.

Taspoglutide is a long-acting glucagon-like peptide-1 analogues with structural modifications which confer intrinsic controlled release properties. Since the structure of taspoglutide is similar to that of the natural human hormone GLP-1, it has the potential for intervals of up to two weeks in between administration without the use of a matrix.

T-emerge 1 is a double-blind, randomized, placebo-controlled, 24 week study, to demonstrate superiority of taspoglutide versus placebo in 373 treatment-naïve type 2 diabetic patients.
Data from T-emerge 1, which included the analysis of 373 patients, showed that taspoglutide demonstrated superior HbA1c reduction versus placebo.

The study enrolled into three arms – taspoglutide 10 mg once weekly, taspoglutide 10 mg 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.

Data from the analysis of 636 patients, showed that taspoglutide demonstrated superior HbA1c reduction versus sitagliptin.

The patients, enrolled into four arms – taspoglutide at doses of 10 mg and 20 mg, sitagliptin 100 mg 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, randomized, controlled, 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 10 mg once weekly and 10 mg once weekly titrated up to 20 mg once weekly after 4 weeks.

Four of the eight studies have active comparators, including exenatide, sitagliptin, insulin glargine and pioglitazone.

Diabetes is a disease characterized by excess blood glucose due to a deficiency in insulin availability and/or resistance to its action. Type 2 diabetes accounts for 90% to 95% of all diabetes cases worldwide and occurs almost entirely in adults.

Coronary artery and peripheral vascular disease, stroke, diabetic neuropathy, amputations, renal failure and blindness are the major complications from diabetes. They result in
increasing disability, reduced life expectancy and enormous health cost for virtually every society.

The number of people with diabetes is set to more than double in the next 20 years to over 300 million by the year 2025, according to current estimates by the World Health Organization.

Ipsen is a specialty pharmaceutical group with over 20 products on the market. Ipsen is targeting therapeutic areas of oncology, endocrinology, neurology and haematology, and primary care products which contribute significantly to its research financing.