New typs of drugs being developed to treat Type 2 diabetes showed the potential to help lower blood glucose levels through a different mechanism than current treatments, according to new studies released at a major diabetes conference.
At present the most advanced drug in the class, dapagliflozin, is being developed by Bristol-Myers Squibb Co. (BMY) and AstraZeneca PLC (AZN, AZN.LN).
The product is designed to lower blood glucose levels in patients with diabetes by increasing the amount of glucose excreted in the urine of people with diabetes. The companies hope to file for U.S. Food and Drug Administration and European Medicines Agency approvals of the product later this year.
Dapagliflozin as well as canagliflozin, a similar product being developed by Johnson & Johnson (JNJ), inhibit sodium-glucose transporter-2 system used by the kidneys to filter and reabsorb glucose circulating in the blood. The products are known as SGLT2 inhibitors.
Data from an advanced Phase 3 study of dapagliflozin involving 807 patients with diabetes who were on insulin showed the drug helped lower A1C blood hemoglobin levels, a common measurement of blood glucose, compared to those receiving a placebo. Some patients in the study were also on other oral diabetes drugs.
Separately, a mid-stage, Phase 2 study of canagliflozin also showed the drug helped lower blood glucose levels in study that involved 451 patients over 12 weeks that was designed to look at different doses of the drug. Johnson & Johnson has started more advanced Phase 3 studies of canagliflozin that will involve more than 10,000 patients.
Both studies were presented Saturday at the American Diabetes Association's annual meeting in Orlando. Diabetes affects about 24 million Americans and is characterized by high blood glucose levels caused by the body's inability to either make or properly use insulin. Type 2 diabetes is the most common form of the disease and is often associated with weight gain and older age. Type 1 is an autoimmune disease often diagnosed in children in which the body's immune system destroys pancreatic beta cells that produce insulin.
The dapagliflozin study was lead by John Wilding, a professor of medicine and the head of the diabetes and endocrinology clinical research unit at University Hospital Aintree in the United Kingdom.
The study enrolled 807 people with type 2 diabetes whose disease wasn't considered well controlled. People in the study had an average A1C level of 8.5%. (People without diabetes typically have an A1C level of less than 6%.)
Patients were divided into four separate treatment groups for 24 weeks. Three groups were given three different doses of dapagliflozin ranging from 2.5 to 10 milligrams daily. One group was given a placebo treatment.
After 24 weeks, patients receiving the lowest dose of dapagliflozin had an average drop in A1C levels of 0.75%, which is considered statistically significant. Patients receiving the highest dose of the drug had an average decline of 0.9% while patients in the placebo group had a decline of 0.3%. The study is still continuing and will last for two years.
Wilding said there was a higher rate of urinary tract infections and genital infections in the study, which could be a side effect of having more glucose released in the urine. (People without diabetes typically don't have sugar or glucose in their urine.)
Higher rates of hypoglycemia, or blood sugar falling too low, were seen among patients treated with dapagliflozin compared to patients not receiving the drug. Hypoglycemia, which can be severe and even fatal, is a side effect of many diabetes treatments including insulin. Wilding said that most cases of hypoglycemia were considered mild and that the most serious cases of hypoglycemia affected about 1% of patients and were split between the placebo and the dapagliflozin groups.
Reports of hypoglycemia seen in the dapagliflozin treatment groups compared to a placebo were 55% for dapagliflozin 2.5 milligrams, 47.6% for dapagliflozin 5 mg, 44.9% for dapagliflozin 10 mg and 42.1% for a placebo.
The study also showed patients in the dapagliflozin group lost slightly more weight than patients in the placebo group and had a drop in blood pressure.
Other companies developing SGLT2 inhibitors include Boehringer Ingelheim and Astellas Pharma Inc (4503.TO).
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