New Diabetic Medications Tested
Drugs to Maintain Normal Blood Sugar Count Likely More Effective
Feb 3, 2009
Lower diabetes blood sugar levels may be a more attainable goal, thanks to a new medication for diabetes called liraglutide. Part of a new class of type 2 diabetes medicines, liraglutide is made by Novo Nordisk, a long-time diabetes research firm with a wide range of products for treatment of diabetes sugar levels. The new drug just finished a large year-long study recently published in the British medical journal The Lancet.
Good News for Those with Type 2 Diabetes
This looks like it could be terrific news for many people who have high diabetes glucose levels that are poorly controlled with metformin medication and sulfonylureas like Amaryl. Liraglutide is similar to exenatide, marketed as Byetta, but Novo Nordisk says trials show it is significantly more effective in improving glycemic control.
Before treatment, participants’ A1C levels ranged as high as 11. With the highest dose studied, liraglutide dropped more than half of users down below the American Diabetes Association’s target A1C level of 7. Other significant benefits included reduced blood pressure and weight loss. The weight loss happened within the first four months, and participants maintained the lower weight a year later.
A key advantage in the way this class of drugs works is the response to the presence of glucose. This method for treatment of diabetes acts only when diabetic sugar levels are high. Because the drug isn’t active when glucose levels are normal or low, there is expected to be a much lower risk of low blood sugar levels than with some current medications.
Tougher Review Process for New Diabetes Drugs
When the new drug may reach the market is uncertain. The company submitted applications in the U.S., Japan and Europe. It is scheduled for a March review by an FDA panel, and WebMD reports that approval seems likely eventually. But recently, the FDA announced that new drugs for diabetes sugar levels will have to pass higher standards before they could be prescribed.
The FDA indicated its screening protocols are tighter to prevent future controversies like the one around Avandia, which is still available even though debate continues over its effect on heart attack risk.
The new policy has tougher standards on testing for diabetes drugs. Pharmaceutical company trials must include more patients who are high risk. That means many who also have more complex type 2 diabetes symptoms and others with diabetes complications such as kidney disease.
Independent experts would have to oversee some key safety measures to assure objectivity in assessing higher risk of heart attack, stroke and related issues. That process will probably take years longer and seems likely to increase drug costs, but according to some experts it won’t stifle new drug innovations and will ultimately benefit people who need help controlling their blood sugar count.
Sources:
Dentistry For Diabetics, accessed 2/2/09
Drug Development Technology, accessed 2/2/09
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