What is Sucanon®?

Clinical Trial Summary

Clinical Results

Regulatory Approvals

SUCANON®



Clinical Results

 

Clinical Experience
The clinical benefits of Sucanon were convincingly demonstrated in a double-blind, randomized, placebo- & Glibenclamide controlled, multi-center, efficacy and safety study in 370 adult patients with Type II diabetes. Sucanon® was administered as tablets, one in the morning and one in the evening. The duration of the study was 6 months; four months treatment, preceded by one month screening evaluation, and followed by one month post-treatment follow-up. Glibenclamide is a commonly prescribed sulfonylurea, its benefits and limitations have been well known to diabetologists for over a decade. The parameters of response to therapy included an evaluation of the changes in clinical signs and symptoms of diabetes, an alteration in the blood and urine measurements of glucose metabolism, and an alteration in blood lipid levels.

 

The results indicated that the parameters of disease activity in patients receiving either Glibenclamide or Sucanon responded in a highly relevant clinical manner and that the differences from baseline measurements were statistically highly significant (p values <0.01). The lack of response in the group of patients who were randomized to receive placebo was also unequivocal, where the effect of administration was clinically small or non-existent, and the baseline to treatment difference was statistically insignificant (p value >0.05). An extract of the data is summarized in the following graphs and tables.

 

Table 1
Changes in glucose abnormalities in 370 Type II diabetic patients in 3 treatment groups of the randomized, double-blind, controlled study (before treatment and at the end of treatment analyses)

 

Table 2
Results from table 1 expressed as "Percent Improvement"(baseline to end of treatment)

 

 

Response to therapy was documented not only by a loss of, or a reduction in, disease related symptoms which included polyuria, polvdipsia, polyphagia, and fatigue, but also by the improvement in objective parameters of disease, namely, a reduction to normal or near normal levels in the elevated fasting blood glucose, and urinary sugar, and a normalization of the 100 g - oral glucose tolerance test. The objective results are given in table 1 above where the mean and standard deviations for these Values are listed, as well as the calculated "t" and “p" values. Given that the coefficient of variance of baseline values for the three treatment groups is small, and the patient number per group relatively large (n = 123), a between treatment group comparison is not unreasonable. These calculations (not shown) reveal that the improvements associated with therapy for both the Glibenclamide group of patients and the Sucanon® group of patients were hoth better than placebo for all objective parameters measured, to a level that was statistically significant (p Values <0.05 to <0.01 respectively. This was not surprising from the t values listed in table 1. The difference in reduction of fasting blood glucose between the latter treatment groups was not statistically significant (p value >.0.05).

 

Table 3
Sucanon associated improvements in blood lipid levels

 


 

 

Pre-clinical pharmacology

Pre-clinical in vivo and in vitro studies have identified that intravenous and oral Sucanon® is pharmacodynamically active in diabetic rats, and out-performed all biguanides and sulfonylureas tested in those models. When added to rat muscle cells, its critical influence commences in seconds as it up-regulates insulin receptors, in a manner not yet understood, With the resultant increase in insulin endocytosis, uptake of glucose and L-leucine effects which last more than an hour.

In single-dose rat studies, peak response in lowering blood glucose takes 2 to 4 hours to occur, and the effect is lost by about 10 hours. Multiple oral dosing in rats (48 davs) and up to 4 months in man, shows no loss of activitv. Clear-cut pharmacological dose-response features were documented. Sucanon® is also superior to other hypoglycemic agents in these models.

 

Toxicity

The therapeutic index is so large (10,000 in mice) that its margin of safety must be unique in the armamentarium of drugs for the treatment of diabetes. Carcinogenicity, mutagenicity, and teratogenicity toxicities were not found in mice. Chronic dosing in dogs and rats at 2000 times the therapeutic dose was free of any toxicity.



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