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Once-Daily Insulin Shot Proves Effective in Study
Date:3/27/2008

Participants preferred it to product requiring three injections a day

THURSDAY, March 27 (HealthDay News) -- Researchers report that a once-daily shot of insulin appears to control blood sugar levels in people with type 2 diabetes just as well as injecting insulin three times a day.

The once-a-day formulation, known as insulin glargine (Lantus), is already on the market, as is insulin lispro (Humalog), which is taken with meals. The new, international study found more patient satisfaction with the glargine.

"This study just confirms that insulin is effective and there are good reasons to use insulin if oral agents are not working," said Dr. Sue Kirkman, vice president of clinical affairs at the American Diabetes Association. "It's certainly not that one is good and one is bad."

The new study did show slight benefits for insulin glargine in terms of patient satisfaction and low blood sugar. But the study was funded by Lantus' maker, Sanofi Aventis, and other studies funded by makers of other insulin formulations have found slight benefits for those products, too, Kirkman noted.

The results are published in the March 29 edition of The Lancet.

Maintaining strict blood sugar control is critical to avoid the complications of diabetes, which can include blindness, kidney failure, and even amputations.

The American Diabetes Association recommends that concentrations of hemoglobin A1c -- a measure of blood sugar control -- remain below 7 percent. Lower levels can substantially reduce the risk of diabetes complications.

Type 2 diabetes -- often linked to being overweight -- is caused by the body's inability to properly use the hormone insulin, which transports blood sugar to the cells for energy. Type 1 diabetes, which is less common, results from the body's failure to produce insulin.

Oral medications, along with lifestyle changes such as improved diet and exercise, can often control type 2 diabetes in the beginning. But, in many cases, insulin needs to be added to a patient's regimen as the disease progresses.

"Diabetes is a worsening epidemic worldwide and studies examining glycemic control are very important," said Dr. Spyros Mezitis, an endocrinologist at Lenox Hill Hospital in New York City. "Diabetes is not well controlled in many patients and insulin is not used early enough in the treatment algorithm for type 2 diabetes to achieve maximal benefit."

Lantus is known as a "basal" insulin analogue, meaning it is given once a day either in the morning or at night; it lasts for about 24 hours. Insulin lispro is shorter-acting and is administered with meals.

For the new study, more than 400 men and women with type 2 diabetes that was poorly controlled by oral medication were randomly assigned to receive either Lantus or Humalog. The trial, conducted at 69 study sites in Europe and Australia, lasted 44 weeks. All participants continued to take oral medications.

Blood sugar control was about equivalent in the two groups, with a decrease of 1.7 percent in the Lantus group and 1.9 percent in the Humalog group.

Lantus was associated with a lower risk of low blood sugar. It also offered the advantages of fewer injections and less blood glucose monitoring throughout the day (only once before breakfast). People taking Lantus also experienced less weight gain, the study authors said.

Certainly, Lantus seems to present another, viable option for people with type 2 diabetes, and one that fits with current treatment recommendations, Kirkman said.

"The American Diabetes Association has a consensus treatment algorithm for type 2 diabetes and insulin is suggested as a second- or third-line treatment," she said. "The suggestion is to start with basal insulin, but that's really primarily because it tends to be easier to convince a patient to go on one shot a day."

Dr. Juan Castro, director of the Texas A&M Health Science Center Coastal Bend Health Education Center, said, "I don't think it [the new study] is going to revolutionize what we're doing but, to clinicians, it really supports what we have seen in the Hispanic population. Historically there has been a lot of resistance with Hispanic patients to accept the idea of being on insulin. This basal insulin gives us a good transition to help patients accept insulin because it's only once a day. If, two to three months later, we need to give them lispro, it's easier for them to accept it."

More information

The American Diabetes Association has more on insulin.



SOURCES: Sue Kirkman, M.D., vice president, clinical affairs, American Diabetes Association, Alexandria, Va.; Spyros Mezitis, M.D., endocrinologist, Lenox Hill Hospital, New York City; Juan Castro, M.D., director, Texas A&M Health Science Center Coastal Bend Health Education Center, Corpus Christi; March 29, 2008, The Lancet


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