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New data support safety profile of diabetes drug

Data show significant and sustained reductions in blood glucose and suggest no dose adjustment will be required for any patient with type 2 diabetes, regardless of stage of renal impairment or kidney function.
New data from the linagliptin late-stage clinical trial programme were presented this week at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD), Stockholm, Sweden.

The studies included two phase III trials and one pharmacokinetic study. Linagliptin belongs to the novel class of DPP-4 inhibitors and is currently in late stage development as a once-daily, single-dose oral tablet for the treatment of type 2 diabetes. A marketing authorisation has not yet been granted for linagliptin.
Linagliptin has a primarily non-renal route of excretion, a pharmacological feature not yet seen in other drugs in this class.

Results from the pharmacokinetic study confirmed that decreases in renal function had only little effect on the elimination of linagliptin and only minor changes were observed in linagliptin exposure in patients with renal impairment (1.4-fold increase in exposure in type 2 diabetes patients with severe renal impairment compared with type 2 diabetes patients with normal renal function). This supports the assumption that linagliptin may not require dose adjustment even in patients with type 2 diabetes and renal impairment.
"Treating type 2 diabetes demands a holistic approach if we want to be successful in helping patients not only achieve but also maintain good blood glucose levels. Kidney function is an important consideration when prescribing an anti-diabetes therapy," said Professor Anthony Barnett, Professor of Medicine and Clinical Director of the Department of Diabetes and Endocrinology, Heart of England NHS Foundation Trust, Birmingham, UK.

"Currently available DPP-4 inhibitors are mainly eliminated via the kidney and therefore not recommended in patients with advanced renal impairment. The clinical data for linagliptin seen to date suggest an advantage in this respect due to its primarily non-renal route of excretion."
This new phase III data adds to the previous body of evidence presented in June at the 70th Scientific Sessions of the American Diabetes Association (ADA) which further demonstrates that linagliptin produces significant and sustainable reductions in blood glucose.
Professor Anthony Barnett concludes, "The clinical data seen to date for linagliptin suggest an interesting and efficacious new treatment option for patients with type 2 diabetes, with the added convenience for both patients and clinicians, of a drug that does not require additional monitoring of kidney function nor dose adjustment."