Drug Helps Tackle Type 2 Diabetes in New Way, Study Says

By Amanda Gardner
HealthDay Reporter

THURSDAY, June 24 (HealthDay News) -- A new drug, the first in its class, gives added blood sugar control to people with type 2 diabetes who are already taking the glucose-lowering medication metformin.

The new agent, dapagliflozin, which also helped patients lose weight, is novel in that it does not work directly on the body's insulin mechanisms, according to a study appearing in the June 26 issue of The Lancet and slated for presentation at the annual meeting of the American Diabetes Association (ADA) in Orlando.

"It will probably be used as an add-on therapy," said study lead author Clifford Bailey, a chemical pathologist and professor of clinical science at Aston University in Birmingham, U.K. "If you don't quite get to target with [the first therapy tried], this approach would offer you an opportunity hopefully to maintain improved control."

Bailey, who could not predict if or when the drug might get final approval from drug regulatory authorities, also pointed out that dapagliflozin is flexible, meaning it can be used with various other treatments and at more or less any stage in the disease.

"It's a good add-on," agreed Dr. Stanley Mirsky, associate clinical professor of metabolic diseases at Mount Sinai Medical Center in New York City. "Is it a wonder drug? No. It may play a small role."

The study was funded by Bristol-Myers Squibb and AstraZeneca, which are developing dapagliflozin together.

Dapagliflozin works by stimulating the kidneys to eliminate more glucose from the body via urine.

In this study of 534 adult patients with type 2 diabetes who were already taking metformin, the highest dose of dapagliflozin (10 milligrams daily) was associated with a 0.84% decrease in HbA1c levels.

HbA1c is a measure of blood sugar control over time.

Participants taking 5 mg of the drug saw a 0.70% decrease in HbA1c levels, while those taking 2.5 mg had a 0.67% decrease.

In the placebo group, the decrease in HbA1c was 0.3%, the study found.

Weight loss was also greater in volunteers taking the study drug: 2.2 kilograms (4.8 pounds) in the 2.5 mg group; 3 kilograms (6.6 pounds) in the 5 mg group; and 2.9 kilograms (6.4 pounds) in the 10 mg group.

Those in the placebo group lost 0.9 kilograms, or almost 2 pounds.

Much, though not all, of this loss was likely to be water weight, the authors stated.

There were more genital infections seen among those taking dapagliflozin, the team noted.

"One of the complications of the drug is an increase in urinary tract infections or yeast infections because you have high glucose levels in the urine," said Dr. Jacob Warman, chief of endocrinology at The Brooklyn Hospital Center in New York City. "That's a very good culture medium for yeast, so the endocrinologists aren't too happy about that."

On the other hand, he said, this drug appears to work without some of the kidney, liver and muscle complications of other drugs so "it would be excellent as an add-on to usual medications."

A second study, also simultaneously being presented at the ADA meeting and published in The Lancet, found that adding inhaled insulin before each meal and long-acting insulin glargine before going to bed worked just as well as taking conventional therapy.

The regular therapy consisted of taking biaspart insulin twice a day. This is a combination of short-acting insulin and intermediate-acting insulin.

The new regimen involved less weight gain, fewer episodes of low blood sugar and was more convenient, according to the study, which was funded by MannKind, the maker of Technosphere, the inhaled insulin featured in the trial.

A third study found that once-weekly injections of the drug Byetta (exenatide) worked better at controlling blood sugar levels than long-acting insulin.

The practice thus far has been to give Byetta twice a day. This study, funded by Amylin Pharmaceueticals and Eli Lilly, looked at a new formulation of the drug.

Patients who got the once-a-week form also lost an average of 2.6 kilograms (5.7 pounds), the study found.

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SOURCES: Clifford J. Bailey, Ph.D., professor of clinical science and chemical pathologist, Aston University, Birmingham, U.K.; Jacob Warman, M.D., chief of endocrinology, The Brooklyn Hospital Center, New York City; Stanley Mirsky, M.D., associate clinical professor of metabolic diseases, Mount Sinai Medical Center, New York City; June 26, 2010 The Lancet