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New Diabetes Treatments Show Promise

Inhaled Insulin, Lizard-Saliva Drug Offer New Options

Medically Reviewed by Brunilda Nazario, MD on October 17, 2005
From the WebMD Archives

Editor's Note: The FDA approved the inhaled insulin drug Exubera in 2006, but in October 2007 the drug company Pfizer said it was halting sales of the drug because of financial reasons.

Oct. 17, 2005 -- Two new diabetes treatments appear to control blood sugar in people with type 2 diabetes who do not achieve glucose control.

Newly published studies highlight the strengths and weaknesses of the two treatments -- a long awaited inhaled version of insulin and a novel injected drug derived from the saliva of the American Southwest's venomous lizard, the Gila monster.

"Both of these new therapies hold promise, but also uncertainty," American Diabetes Association president Robert Rizza, MD, tells WebMD. "They will increase the options for people with diabetes."

Improving Blood Sugar

People with type 2 diabetes progressively lose their ability to make and use their own insulin, an important hormone that the body needs to process sugar. The aim of treatment is to improve impaired blood sugar control to reduce the risk of diabetic complications.

This might be possible with diet and exercise alone early in the disease process, or a single medication to either enhance insulin secretion or help increase insulin sensitivity like the drug Metformin.

Later on, patients may be put on a combination of diabetes drugs, but eventually many need daily injections of insulin to control their blood sugar levels.

The two new treatments were tested in people with type 2 diabetes whose blood sugar could no longer be controlled with a combination of these pills for diabetes.

Both studies are published in the Oct. 18 issue of the Annals of Internal Medicine.

Weight Gain, Weight Loss

Unlike most other medications used to treat type 2 diabetes, including insulin, the new drug exenatide, made from the saliva of the Gila monster, does not cause weight gain. In fact, most patients lose some weight while taking the drug.

In a 26-week study comparing twice-daily injections of exenatide to long-acting, once-daily injections of insulin, patients on both treatments achieved similar blood sugar control. On average, those taking exenatide lost an average of 5 pounds, while those on insulin gained about 4.

But the exenatide group reported much higher rates of gastrointestinal side effects, with 57% reporting nausea, compared with 9% of the insulin patients, and 17% reported vomiting, compared with just fewer than 4% of those on insulin.

Overall, roughly 19% of the patients taking exenatide withdrew from the study because of side effects vs. just under 10% of those on insulin.

Patients receiving exenatide showed more improvement in blood glucose level after meals compared with the long-acting insulin (glargine), yet those taking long-acting insulin showed a greater reduction in fasting blood sugars compared with exenatide.

Both drugs similarly improved overall blood sugar control in people with type 2 diabetes with less than adequate control with a combination of oral diabetes medications, concludes the study.

The study was funded by exenatide manufacturer Eli Lilly and Co., a WebMD sponsor.

No More Needles

In a separate three-month trial involving 309 patients, the inhaled insulin Exubera was compared with treatment with two blood sugar-lowering drugs or in combination with the two treatments.

The groups receiving Exubera either alone or in combination with the two diabetes pills achieved better blood sugar levels than those taking oral medications use to enhance insulin secretion or increase insulin sensitivity.

But mild weight gain was seen in patients taking the inhaled insulin and was similar to that seen with injected insulin.

Exubera therapy resulted in more low-blood-sugar episodes (hypoglycemia) than those taking the combination oral drug alone. The study was paid for by Exubera manufacturers Pfizer Inc. and the French company Sanofi-Aventis. Both companies are WebMD sponsors.

An FDA advisory panel recently approved Exubera, and experts tell WebMD that they expect the treatment to be commercially available soon.

Patients would be expected to embrace an alternative to insulin shots, and studies have shown that, in theory, this is the case. But the experts say acceptance of inhaled insulin is far from certain.

That is because the insulin-delivery device is relatively large -- about the size of a standard flashlight -- and it must be used before every meal.

"Most people picture an asthma inhaler, but this is much bigger," diabetes treatment expert Richard Comi, MD, tells WebMD.

There is also some concern about the long-term toxicity of inhaled insulin, says Rizza. And Comi expressed concerns about whether smokers and patients with lung problems will be candidates for inhaled treatment.

The inhaled insulin comes in a dry powder delivery system similar to some asthma inhalers. When it hits the lungs, it's absorbed directly into the bloodstream, allowing it to take effect faster than injected insulin.

Time Will Tell

Rizza and Comi agree that only time with tell if patients will flock to the two new diabetes treatments.

"I can tell you that my patients have told me that they would love to exchange their needles for inhaled insulin, even if its delivery is somewhat cumbersome," says Comi, who is chief of endocrinology at New Hampshire's Dartmouth Hitchcock Medical Center. "But I think it is impossible to know what patient acceptance will be until [these treatments] are out there."

Show Sources

SOURCES: Rosenstock, J. and Heine, R.J. Annals of Internal Medicine, Oct. 18, 2005; vol 143: pp 549-569. Robert Rizza, MD, president, American Diabetes Association; chairman, division of endocrinology and professor of medicine, Mayo Clinic College of Medicine, Rochester, Minn. Richard J. Comi, MD, chief of endocrinology, Dartmouth Hitchcock Medicine Center, Lebanon, N.H. WebMD Medical News: "Inhaled Insulin Appeals to Diabetes Patients."

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