Oct 17 2006
The Food and Drug Administration (FDA) in the U.S. has granted approval for a new drug to treat adults with type 2 diabetes.
The new drug, Januvia (sitagliptin phosphate), is taken orally, and has the ability to control blood sugar levels in the body without causing the patient to gain weight, a common side-effect with current treatments.
Type 2 diabetes, affects the majority of the nearly 21 million Americans with diabetes which is the result of the body building resistance to insulin, needed to break down food and it causes blood sugar levels to be too high.
Obesity is a major risk factor for the disease, which if not controlled can lead to heart problems, blindness and other complications.
The FDA says Januvia can be used on it's own or in combination with other oral diabetes drugs such as metformin and PPAR agonists.
Common side effects in trials were diarrhea, sore throat and upper respiratory tract infections.
The FDA advises that diet and exercise should also be part of the treatment.
Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, says the new medication treats the disease in an entirely new way and is another option for type 2 diabetes patients who continue to have inadequate blood sugar control.
He says it can be added to existing treatment regimens to help patients gain more control over their blood sugar levels.
Insulin injections are necessary in order for some type 2 diabetes sufferers to control their blood sugar levels, while others rely on oral medicines.
The one a day pill made by Merck will be in direct competition with a rival drug by from Novartis called Galvus, which is still waiting for FDA approval.
Both drugs belong to a new class of medicines called dipeptidyl peptidase IV, or DPP-4, inhibitors that work to enhance the body's own ability to lower blood sugar.
Both drugs showed in clinical the advantage of no weight gain.
Older diabetes medications are known as thiazolidinediones, or TZDs, which make patients less resistant to insulin are often used as additional treatments and are associated with water retention and weight gain.
In a trial with 2,719 patients it was seen that Januvia provided better blood sugar control when used alone or in patients not satisfactorily managed with metformin or a PPAR agonist.
The vast majority of doctors are eager to prescribe the new drugs as the ability to control blood sugar without the added weight gain is seen as a huge advantage
Treatment with Januvia is expected to cost between $3 - $6 per day.