Roche study drug may offer valuable new treatment option for patients with type 2 diabetes

RocheRoche has announced that results from the first five Phase III clinical trials show that taspoglutide has met the primary end-points of reduction in blood glucose (blood sugar) in these studies. Roche's taspoglutide, the first weekly human GLP-1 analogue in late stage development may improve treatment options for patients with type 2 diabetes.

Taspoglutide is similar to the naturally occurring human hormone GLP-1 which plays a key role in blood glucose metabolism through a range of mechanisms, including improvement of insulin secretion, suppression of abnormal glucose production by the liver, slowing food absorption through the gut and suppressing appetite in animal studies resulting in glycaemic control and weight loss with a low risk of hypoglycaemia. Roche's Phase III clinical trials programme – called T-emerge - includes placebo-controlled and active-comparator controlled studies with current standards of care* in patients treated with metformin or other therapies as well as evaluating the effect of this innovative option in patients who are not controlled on diet and exercise alone.

"Taspoglutide's consistent robust efficacy data across studies in terms of glucose control, when compared head-to-head with other widely prescribed diabetes treatments, are encouraging. This weekly GLP-1 receptor agonist has the potential to become a valuable new treatment option for patients with type 2 diabetes," said one of the lead investigators, Julio Rosenstock, MD, Director of Dallas Diabetes and Endocrine Center at Medical City and also Clinical Professor of Medicine University of Texas Southwestern Medical School.

In all five studies taspoglutide was generally well tolerated; the most frequently reported adverse events among taspoglutide treated patients were nausea and vomiting which is an expected occurrence in all medications in this class.

"These Phase III studies have shown that treatment with once weekly taspoglutide leads to significantly improved blood glucose control, consistent weight loss, a minimal risk of hypoglycaemia, and manageable safety profile. We believe taspoglutide has the potential to become an important therapy for diabetic patients," said Hal Barron, Global Head of Product Development at Roche.

Roche exercised its licensing option for taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market taspoglutide, except in Japan where these rights are shared with Teijin and in France where Ipsen may elect to retain co-marketing rights.

About the T-emerge Programme
The T-emerge Phase III clinical trial programme is designed as multicentre, multi-country, randomized, 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 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.

T-emerge 1: Double-blind, randomized, placebo-controlled study versus placebo in 373 treatment-naïve type 2 diabetes patients (taspoglutide at doses of 10 and 20 mg, and placebo).

T-emerge 2: Open-label core study versus exenatide, involving 1189 patients, equally randomized into three active arms (taspoglutide at doses of 10 and 20 mg, and exenatide 10-μg).

T-emerge 4: Head-to-head comparison study versus sitagliptin (Januvia®) as add-on to metformin involving 636 patients who have failed to reach their treatment targets with metformin (taspoglutide at doses of 10 and 20 mg, sitaglipton, and placebo).

T-emerge 5: Head-to-head comparison study of taspoglutide versus insulin glargine (Lantus®) as add-on to metformin in patients failing on metformin and sulfonylurea with 1,049 patients equally randomized into three arms (taspoglutide at doses of 10 mg and 20 mg, and insulin glargine once daily).

T-emerge 7: Combination therapy study of taspoglutide as add-on to metformin in patients with high BMI involving 305 patients equally randomized into two arms (taspoglutide at a dose of 20 mg, and placebo).

About Diabetes
Type 2 diabetes is a global epidemic growing at an exponential rate. Currently type 2 diabetes affects more than 180 million adults worldwide and the number is expected to escalate to over 360 million by the year 2030. Type 2 diabetes accounts for 90% to 95% of all diabetes cases and is causally linked to obesity; as many as 90% of type 2 diabetes patients worldwide are overweight or obese. Weight management is thus often an important clinical goal. Despite available therapies, managing type 2 diabetes remains a challenge due to the multi-faceted nature of the disease, complex treatment regimens and the constant demand on life style modification. Many patients struggle with therapy related side effects such as weight gain and hypoglycaemia as a trade off for glucose control. Approximately two-thirds of patients fail to achieve an HbA1c < 7%, and nearly 90% of patients fail to reach the combined treatment goals of glucose control, blood pressure and lipids.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80'000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

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