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New Interim Analysis From Observational Study Suggests That Delivery Of Insulin Via Valeritas' V-Go Shows Promise In Improving Glycemic Control For Patients With Type 2 Diabetes
Date:5/2/2013

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The primary objective of the observational study was to compare change of average glycemic control as measured by A1C from baseline to the end of V-Go use for the whole cohort as well as each of the categories of baseline treatment. Patients in the study were followed on their current therapy for up to 6 weeks before starting the V-Go insulin delivery device. The study, observational in nature, has no mandated or forced titration instructions to guide insulin therapy with the exception of starting doses for V-Go basal rate options.1

The interim analysis of the observational study suggests that 47 patients had continuous V-Go use for a minimum of 3 months. Most of the patients in the study were men with an average age of 60 having diabetes for 13 years. At the time of this interim analysis, A1C levels for the study participants reduced from 9.0 percent to 8.6 percent during the 4 to 6 week run-in phase. After the run-in period and starting the V-Go, the interim results suggest that patient A1C levels further improved with a mean change from 8.6 percent to 7.8 percent; P<0.0001 from month 0 to month 3. Five patients reported adverse events probably related to V-Go (primarily rash or skin irritation). Six patients reported hypoglycemia <70 mg/dL. There was no significant change in weight. Additionally, total daily insulin dose was reduced by 19 percent (12.5 units) on average.1

About Diabetes

In order to fuel the human body's cells with glucose, or sugar, insulin is required. While the body continuously produces insulin, people with Type 2 diabetes, the most common form of diabetes, either do not produce enough insulin, or their bodies cannot use the insulin adequately. When there is not enough, or insulin is not used properly, glucose builds up in the blood instead of going into the body's cells. If not controlled properly, diabetes can increase the risk of heart disease, blindness, amputati
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SOURCE Valeritas, Inc.
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