Lowering elevated glucose has long been viewed as the primary goal in the treatment of diabetes mellitus. Furthermore, this goal has come into renewed focus after the publication of the Diabetes Control and Complications Trial (DCCT) in the September 1993 issue of The New England Journal of Medicine. The DCCT, a pivotal study in the treatment of diabetes, concluded that improved glycemic control reduces the progression of microvascular complications caused by diabetes, namely retinopathy and neuropathy. However, concerns have been raised that the achievement of tight control in the type II diabetic population using currently available therapies might exacerbate the hyperinsulinemia and obesity often associated with this disorder. Preliminary data has shown that recombinant human insulin growth factor (rhIGF-1) is a therapeutic agent that does not raise endogenous insulin levels or increase weight in subjects with type II diabetes. In vitro studies have revealed that IGF-1 can mimic insulin's capacity to promote glucose uptake and metabolism in isolated muscle and adipose tissue, stimulate glycogen synthesis in rat heart and diaphragm muscles, accelerate amino acid transport in fibroblasts, and increase net protein synthesis in cartilage. Furthermore, in states of severe insulin resistance, results from small studies (one to three subjects) indicate that IGF-1 is able to decrease serum glucose concentrations while also decreasing insulin levels and apparently improving insulin sensitivity. This study will help ascertain the benefits of the addition of IGF to insulin therapy with regard to glycemic control, hypoglycemia, and risk of weight gain. The goal of this study is to identify a safe, tolerable, and effective dose of IGF-1 for the treatment of patients with type II diabetes mellitus who are taking at least 50 units of insulin daily prior to enrollment into study. Each patient is randomized to 1 of 4 treatment groups, a total daily dose of 40, 80, 120ug/kg, or placebo. Patients are evaluated in the hospital at randomization and after 12 weeks of treatment for a fasting lipid profile, 24 hour plasma glucose, insulin, pharmacokinetic profile, and CT of visceral and mid-thigh fat. Additionally, each patient is evaluated in the clinic every 2 to 4 weeks, including Hemoglobin A1c (HgA1c), home blood glucose results, and total daily insulin dose. This multi-center study has been completed, but the results are not yet available. All sites have submitted there data to the sponsor, and are awaiting the results/conclusions. Our IRB is currently reviewing a similar protocol using IGF in patients with secondary sulfonylurea failure, which we will soon begin.
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