VIVUS' Qnexa Shows Significantly Improved Blood Sugar Control Through Weight Loss In Patients With Type ... (ined weight loss. The 56-week r...)

VIVUS' Qnexa Shows Significantly Improved Blood Sugar Control Through Weight Loss In Patients With Type 2 Diabetes

Date:6/8/2009

ined weight loss."

The 56-week randomized, double-blind, placebo-controlled, efficacy and safety study showed:

Patients treated with Qnexa achieved a 1.6% reduction in HbA1c (from 8.8% to 7.2%), as compared to 1.1% (from 8.5% to 7.4%) in the placebo group (p<0.05), despite the addition of diabetes medications required in the placebo group during the course of the study;
Patients on Qnexa had continual reductions in fasting plasma glucose (FPG) throughout the entire one-year treatment. FPG levels were reduced in subjects treated with Qnexa from 176 mg/dL to 133 mg/dL, as compared to a decrease from 171 mg/dL to 145 mg/dL for the placebo group (p=0.02). Additionally, patients had improvements in postprandial glucose as measured by increases in GlycoMark(TM). GlycoMark improvement were demonstrated and were significantly greater in patients taking Qnexa (p=0.01).
Patients treated with Qnexa lost 9.4% of their baseline body weight, or 20.5 pounds, as compared to 2.7%, or 6.1 pounds, for the placebo group (p<0.001);
65% of the Qnexa patients lost at least 5% of their body weight as compared to 24% in the placebo group (p<0.001), and 37% of the Qnexa patients lost at least 10% of their body weight as compared to 9% of patients in the placebo group (p<0.001);
Patients treated with Qnexa demonstrated reductions in blood pressure, triglycerides and waist circumference.

Overall, the study had a greater than 90 percent completion rate. All results were evaluated based on an intent-to-treat population using the last observation carried forward, known as ITT-LOCF, the method of analysis required by the U.S. Food and Drug Administration.

"Type 2 diabetes is a challenging disease to manage for clinicians and patients alike, especially given the high incidence of co-morbid conditions a
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