The clinical trial is an 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.
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.
The lead researcher, Professor David Dunger, believes the research to be an important step forward in an area where no effective therapies currently exist. The professor, pleased by the opportunity to further investigate SomatoKine said; “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.”
Individuals with Type A insulin resistance who develop frank diabetes require large doses of subcutaneous insulin, oral hypoglycemic agents and insulin sensitizers. Despite this intense regimen, glycemic control remains poor and these patients are at high risk of the complications of diabetes, such as cardiovascular disease, nephropathy, retinopathy and neuropathy.