Boehringer cheered by diabetes data

pharmafile | June 28, 2010 | News story | Research and Development Boehringer, DPP-4, diabetes, linagliptin 

Boehringer Ingelheim has been cheered by phase III data showing its new oral once-daily type II diabetes tablet linagliptin significantly lowered blood glucose with no safety issues.

Presented last week at the 70th Scientific Sessions of the American Diabetes Association, the data showed “significant, sustained and clinically meaningful reductions” in haemoglobin, fasting plasma and postprandial glucose.

Results also suggest the drug would not need dose adjustment in patients regardless of the stage of renal impairment – a potentially significant development.

“Only approximately 5% of the orally administered drug is excreted via the kidneys,” said Julio Rosenstock, director of the Diabetes and Endocrine Center at Medical City in Dallas, Texas.

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“Data to date appear to indicate that linagliptin would not require dose adjustment, which could translate into an important benefit for physicians when choosing a treatment.”

This means it may be of use beyond the type II diabetes patient population, perhaps for other patients at risk of developing renal complications, he explained.

The dipeptidyl peptidase (DPP) -4 inhibitor is set to enter a market which already contains two approved DPP-4s: MSD’s Januvia (sitagliptin) and Novartis’ Galvus (vildagliptin).

It will also be up against new DPP-4 Onglyza (saxagliptin), marketed by Bristol-Myers Squibb and AstraZeneca.

GlaxoSmithKline may also be looking on anxiously as linagliptin is a potential threat to its older oral diabetes treatment Avandia (rosiglitazone).

The phase III trial suggested linagliptin’s tolerability was excellent, there was no weight gain and it showed no increased risk of hypoglycaemia either as monotherapy or in combination with metformin or pioglitazone.

The results square with phase II studies, where it was given as add-on therapy to patients inadequately controlled with metformin.

DPP-4 inhibitors affect incretins, the hormones that lower blood sugar levels by increasing the body’s utilisation of sugar. The class is effective at lowering blood sugar levels without side-effects such as weight gain.

Boehringer Ingelheim’s promotional efforts for the drug include its recently launched European disease awareness website, diabeteshealthlounge.com.

Meanwhile, AstraZeneca-funded research has shown that UK diabetes rates are growing at a faster rate than in the US, with two million sufferers in this country and more than 100,000 diagnosed each year.

Linked to obesity, type II diabetes sufferers experience related complications such as cardiovascular disease and renal failure.

An estimated 250 million people have diabetes worldwide, with 3.8 million deaths each year, and the International Diabetes Federation says sufferer numbers will rise to 380 million in the next 15 years.

Adam Hill

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