Pre-diabetes is an increasingly common public health problem that has been recognized by international organizations such as the World Health Organization, the American Diabetes Association, and the International Diabetes Federation. If effective treatment is not available, 70%-90% of pre-diabetes patients will develop type 2 diabetes. Valedia is the first product to be clinically proven to reduce the risk of developing type 2 diabetes in pre-diabetic patients. The active pharmaceutical ingredient of Valedia is TOTUM-63. This is a unique combination of five plant extracts with up to 63 total bioactive molecules, synergistically targeting five key metabolic organs (liver, pancreas, intestine, muscle, adipose tissue) targeting the physiological and pathological mechanisms of type 2 diabetes. In clinical research, TOTUM-63 is a pure natural product that exhibits perfect tolerance and safety.
Recently, Valbiotis published additional positive results for four parameters in a secondary endpoint of a Phase IIa clinical study evaluating Valedia (active ingredient: TOTUM-63) in patients with pre-diabetes.
Figure 1 Results of Valedia in the Phase IIa Clinical Study of Prediabetes Patients (Valbiotis Corporate presentation 2019)
The top line results previously published (July 3, 2019) showed that Valedia significantly reduced blood glucose levels and body weight compared with placebo. The additional secondary endpoints presented this time showed that compared with placebo, Valedia significantly reduced blood triglyceride levels by 32.2%, fatty liver index (liver fat accumulation) by 18.7%, and blood low-density lipoprotein cholesterol (LDL-C) levels by 11.7%, arterial hypertension significantly reduced 10.6 mm Hg (significantly reduced 18.9 mm Hg in hypertensive patients). Based on the above results, Valedia is the first product to be clinically proven to be effective in reducing pre-diabetes patients with multiple risk factors for type 2 diabetes, and for various abnormalities such as carbohydrates and lipid metabolism and arterial hypertension. The results of Phase IIa studies have exceeded all established goals, and Valedia’s overall efficacy for subjects at risk for metabolic disease has been confirmed.
The study was a multicenter, randomized, double-blind, placebo-controlled study conducted in pre-diabetic patients in Europe to assess the efficacy and safety of Valedia versus placebo. In the study, subjects received 5 grams of Valedia daily, and the control group received 5 grams of placebo daily for 6 months. During the study period, the dietary habits and physical activity levels of the two groups remained unchanged. The results showed that Valedia significantly reduced fasting and postprandial blood glucose levels in this cohort compared with placebo, which is the two major risk factors for type 2 diabetes and the primary and secondary endpoint of the study. Valedia also significantly reduced body weight and waist circumference compared to placebo.
Based on the data from this study, Valbiotis has initiated the last two Phase IIb clinical studies (REVERSE-IT and PREVENT-IT). Because moderate fasting hyperglycemia is a major risk factor for type 2 diabetes in pre-diabetes patients, the primary endpoints of these two studies were set to fasting blood glucose levels, and data will be used to support health claims for lowering the risk of type 2 diabetes in Valedia in Europe and North America. This regulatory process does not require a Phase III study. As mentioned earlier, Valedia’s commercialization plan was carried out in 2021. In clinical research, TOTUM-63 is a pure natural plant product that exhibits perfect tolerance and safety.
1.Valbiotis Corporate presentation – July 2019
2.VALBIOTIS Announces Additional Positive Results From the Phase IIA Clinical Study of VALEDIA?, the First Product Proven Effective in People With Prediabetes, in Lipid Metabolism and Arterial Hypertension