FDA Approves New Drug for Type 2 Diabetes

The 29.1 million people living with type 2 diabetes now have another medication available to help them manage their blood sugars.

The U.S. Food and Drug Administration (FDA) recently approved the drug lixisenatide for treatment of type 2 diabetes. In clinical studies, the drug has been proven more effective than current medications at lowering postprandial (after-meal) blood glucose levels. The drug will be available in disposable pre-filled pens, which contain a single dose of either 10 or 20 mcg.

Clinical Evidence

The FDA approved lixisenatide based on the results of the GetGoal clinical program. In this series of 13 clinical trials, scientists evaluated over 5,000 type 2 diabetics across the globe, comparing the effects of lixisenatide against two other sample groups. One group took a placebo as a monotherapy, and the other took a placebo as an adjunct therapy to both oral antidiabetics.

Ultimately, the results of all trials were the same: lixisenatide managed to lower a test subject's A1c (between 0.7 and 1 percent), weight (between 0.2 and 2.96 kg), and 2-hour postprandial blood sugar readings (between 3.1 and 7.96 mmol/L). These results proved that the drug was more effective than the placebo or current antidiabetic medications.

A Few Warnings

Though most test subjects generally tolerated lixisenatide well, there were a few side effects the clinicians made sure to note. The most common side effects were only present in fewer than five percent of patients, and they were: nausea (25%), vomiting (10%), headache (9%), diarrhea (8%), dizziness (7%), and hypoglycemia (2% when lixisenatide was taken as monotherapy, 3% to 47% when it was part of a combination therapy).

Additionally, the FDA noted in their recommendation that lixisenatide was approved for treatment of type 2 diabetics “along with diet and exercise.” It is important to note that healthy lifestyle choices are critical to managing one's type 2 diabetes well, regardless of the medication a person may be taking.

Source: Modern Medicine Network

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