News Briefs for Kombiglyze XR, Diamyd, and Lorcaserin

FDA OKs Kombiglyze XR, a Once-a-Day Type 2 Med That Combines Metformin and Onglyza.

The FDA has approved the use of Kombiglyze XR, a drug that combines metformin and Onglyza, to treat type 2 diabetes in adults.

Produced by Bristol-Meyers Squibb and AstraZeneca PLC, the once-a-day drug comes in an extended-release pill. It combines the companies’ proprietary drug Onglyza, a DPP-4 inhibitor introduced in August 2009, with metformin, the inexpensive drug that doctors often prescribe for people with pre-diabetes or newly diagnosed cases of type 2.

Kombiglyze has not been studied for use in treating type 1 or in combination with insulin use.

Diamyd Readies Phase III Study of Drug Designed to Halt or Slow Beta Cell Destruction in Type 1s

Swedish pharmaceutical company Diamyd Medical is ready to begin the Phase III U.S. study of its drug, Diamyd®, after completing the recruitment of 320 type 1 patients between the ages of 10 and 20 years.

The U.S. study, called “DiaPrevent,” is part of a global Phase III program. It will investigate whether Diamyd can halt or slow the destruction of beta cells in the pancreases of people with type 1 diabetes, preserving the body’s own ability to control blood sugar levels. In Phase II studies, the drug successfully slowed the loss of beta cell function compared to placebo.

FDA Nixes Approval of Obesity Drug Lorcaserin

Citing concerns about incidences of cancer in laboratory rats and a desire for more clinical data, the U.S. Food and Drug Administration has declined to approve lorcaserin, a weight-loss drug produced by San Diego-based Arena Pharmaceuticals and Eisai, a Japanese company.  

In clinical studies, 37.5 percent of 600 patients taking lorcaserin achieved a weight loss of at least 5 percent, compared with 16.1 percent of those taking a placebo. Patients taking the drug achieved an 0.9 percent reduction in their A1Cs, compared to 0.4 percent for those taking a placebo. Fasting glucose levels improved, but the drug had no effect on fasting insulin, triglyceride levels, cholesterol, or blood pressure.

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