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www.fdanews.com/articles/71550-insmed-begins-trial-with-somatokine-in-type-a-extreme-insulin-resistance

Insmed Begins Trial With SomatoKine in Type A Extreme Insulin Resistance

April 26, 2005

Insmed has initiated a Phase II clinical trial examining the therapeutic benefit of treating Type A Extreme Insulin Resistance with SomatoKine, the company's proprietary once daily IGF-I therapy.

The clinical trial is a Phase II, open-label, dose-ranging study designed to evaluate the safety and efficacy of SomatoKine for 16 weeks in 10 patients with Type A Extreme Insulin Resistance. To qualify for inclusion in the study, patients must be between 10 and 65 years of age and have a diagnosis of Type A insulin resistance.

The primary efficacy endpoints of the trial are improvement in glycemic control, improvement in insulin sensitivity, reduction in hemoglobin A1c and improvement in body composition.