Insmed Incorporated has initiated a Phase II clinical trial examining the therapeutic benefit of treating Type A Extreme Insulin Resistance (EIR) 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 10-65 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 haemoglobin A1c and improvement in body composition.
"As there are no effective therapies for these patients and the long term prognosis of declining health is well documented, I am pleased to have the opportunity to be evaluating SomatoKine as a potential treatment to reverse the significant insulin resistance and abnormalities in these patients," commented Principal Investigator Professor David Dunger. "Our past studies have demonstrated that with SomatoKine administration, these abnormalities can be overcome leading to an improved insulin sensitivity with ultimately better blood sugar control," he added.
Syndromes of Insulin Resistance result from genetic defects in the insulin receptor or insulin signaling pathways. In addition to insulin resistance and glucose intolerance or overt diabetes, these syndromes share a number of common features including variable degrees of hyperandrogenism, hirsutism, and dysmorphic features.
Insmed's SomatoKine is a proprietary drug product of insulin-like growth factor-I (IGF-I) and its principal binding protein, IGFBP-3.