* Dapagliflozin meets primary end-point in late-stage trial
* Weight loss also seen with Astra, BMS drug
* Data is latest in series of successful Phase III trials
By Kate Kelland
LONDON, Sept 24 (Reuters) - An experimental diabetes drug from AstraZeneca (AZN.L) and Bristol-Myers Squibb (BMY.N) met its target in a late-stage trial as a combination therapy, working as well as a comparison in reducing blood sugar levels.
Data released at the European Association for the Study of Diabetes (EASD) conference in Stockholm on Friday also showed that the drug, dapagliflozin, helped diabetes patients lose weight when given in combination with the generic treatment metformin.
Compared with a combination of glipizide plus metformin over a 52-week trial, dapagliflozin reduced the number of patients reporting one or more hypoglycaemic events — when blood sugar falls to dangerously low levels — the data showed.
Glipizide is one of an older class of diabetes drugs known as sulfonylureas.
Dapagliflozin, a once-daily pill, is a member of a class of drugs known as SGLT2 inhibitors, designed to block reabsorption of glucose. If approved, it could be the first such drug to reach the market. AstraZeneca and BMS have said they might file for approval late this year or early 2011.
“Type 2 diabetes patients often present with multiple co-morbidities in addition to their blood sugar levels,” said Michael Nauck, head of the Diabetes Centre at Bad Lauterberg in Germany, who led the study.
“We are pleased to see the results from this Phase III study found that dapagliflozin plus metformin compared favourably to glipizide plus metformin, helping patients lower their HbA1c levels with a lower risk of hypoglycaemia.”
The study, which included 814 adult patients with type 2 diabetes, found that after 52 weeks those taking dapagliflozin plus metformin, compared to those taking glipizide plus metformin, achieved the same 0.52 percentage point reduction in HbA1c — a key indicator of glucose concentration in the blood.
It also found that patients treated with dapagliflozin plus metformin lost an average of 3.22 kilos in body weight over the 52-week trial, compared with an average gain of 1.44 kg among those taking glipizide plus metformin.
The Bristol-Myers and Astra drug is the farthest along in development from the SGLT2 class and Friday’s data were the latest in a series of successful Phase III trials. Johnson & Johnson (JNJ.N) is also developing a SGLT2 inhibitor drug called canagliflozin, which is also in Phase III trials.
An estimated 200 million people across the world have diabetes. Most have type 2 diabetes, the kind linked to poor diet and lack of exercise. In 2009, sales of diabetic drugs, including insulin, totalled $27 billion, according to industry analysts at Deutsche Bank. (Editing by Michael Shields)