The current medical literature contains many reports of studies with oral hypoglycemic agents.1-3 These substances thus far have been sulfonylurea derivatives with blood-sugar-lowering ability in certain types of diabetes. Within the last year studies were started with a new group of compounds classified as formamidinyliminoureas.These drugs are biguanides, not to be confused with the diguanidines, which include Synthalin (guanidine-deca-methylene-guanidine) (Fig. 1). They also have no structural relationship to either carbutamide or tolbutamide and have no sulfonyl radical in their formulae. Ungar et al.4 recently reported that one of these agents, phenethylformamidinyliminourea hydrochloride, was effective orally in both normal and alloxandiabetic animals. He also re-ported5 the uptake of glucose by a rat diaphragm preparation. Williams6 reported a hypoglycemic effect in animals, and Nielsen et al.7 stated that this hypoglycemic effect was observed in depancreatized animals. Pomeranze8 first demonstrated successful hypoglycemic effects in clinical trials with patients. This present report is a clinical evaluation of the effectiveness of a DI6UANIDINE Figure 1 amidinyliminourea hydrochloride, referred to hereafter as DBI. The object of this study was to observe the blood-sugarlowering effect of this preparation, to de¬ termine side-effects or evidence of toxicity, and to evaluate effective dosage. Blood sugar lowering was the primary object of this study, with "control" as a by-product observed secondary to the main objective.
Materials and MethodsOne hundred twenty-one diabetic patients were observed for periods varying from one day to six months. They were hospitalized, maintained with a constant weighed diet, and observed individually by three physicians. Patients previously receiving insulin had DBI substituted for the insulin. Newly discovered diabetic patients were treated with DBI immediately after the diagnosis had been estab¬ lished. Laboratory studies consisted of fasting venous blood sugar determinations and capillary blood sugar tests repeated at intervals throughout the day. The Somogyi-Nelson " method was used. Benedict urine sugar tests were done four times daily, as well as an estimation of sugar in the 24hour collection of urine. Each patient had a com¬ plete blood cell count and differential determination, as well as a complete urinalysis. Most of the patients had liver-function studies, including sul fobromophthalein ( B romsulphalein ), thymol turbidity and flocculation, alkaline phosphatase, cephalin flocculation, and blood bilirubin tests prior
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