Insulin therapy clinical studies

Receptor-mediated endocytosis may be possible because receptors have a high affinity for BDNF (Deckner et al. 1993). A linear relation between intranasal administration of -labeled NGF and brain concentrations of the compound suggest that this transportation is not mediated by receptors and that this releasing method of agents to the brain via olfactory nerves may be effective for many therapies (Frey et al. 1995). BDNF and the insulin-type growth factor (IGF-1) are currently used in clinical studies (Appel 1997). 

The importance and need for intensified insulin therapy in the treatment of insulin-dependent diabetes, however, seems to be not yet fully settled, despite the fact that nearly all clinical studies that compared CSII and/or... 

The serum cholesterol-lowering effect of plant sterols and stanols has been proven in several clinical studies. The hypocholesterolemic effects have been verified in normocholesterolemic individuals, in individuals with mild to moderate hypercholesterolemia or with familial hypercholesterolemia, in women with coronary heart disease, and in men with non-insulin-dependent diabetes -in conjunction with cholesterol-lowering statin therapy and irrespective of the background diet. In addition, studies have been conducted with normocholesterolemic children and with children with slightly elevated cholesterol levels, or with familial hypercholesterolemia. 

In studies in the 1970s peripheral edema developed in 15 of 86 middle-aged insulin-treated patients (112) and between 4 and 10% of intensively treated people with type I diabetes (113). In later studies of patients with type 2 diabetes, 5.4% of 408 patients treated with insulin developed edema compared with 15% of those who received insulin and a glitazone. In a further study edema occurred in 4.8% of patients who used rosiglita-zone alone (114). Insulin can cause edema that can become clinically significant, particularly when it is combined with other therapies that cause edema. 

Raskin P, Rendell M, Riddle MC, Dole JF, Freed MI, Rosenstock JRosiglitazone Clinical Trials Study Group. A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. Diabetes Care 2001 24(7) 1226-32. 

Troglitazone, the first clinically available thiazolidinedione, was approved for use in patients who have failed diet therapy and, in combination with insulin and/or sulfonylureas, in patients inadequately controlled with these agents alone (117). Although studies have documented the hypoglycemic efficacy of troglitazone in patients with type 2 diabetes, its use was associated with elevated liver enzymes, liver damage, and death... 

Carcinogenicity studies are not generally needed for endogenous substances, when given essentially as replacement therapy (i.e., physiological levels), particularly, where there is previous clinical experience with similar products (for example animal insulins, pituitary hormones). 

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