Valedia®

Context

Prediabetes affects 527 million people worldwide.  

Diabetes affects 415 million people in the world. The disease caused over 5 million deaths in 2015 and generated close to 673 billion dollars in health expenditure worldwide due to scope of the disease and the seriousness of its complications. Although type 2 diabetes (once diagnosed) is irreversible in the vast majority of cases, its risk condition, prediabetes, which is defined by the American Diabetes Association as a fasting plasma glucose level between 100 mg/dl and 125 mg/dl, is reversible. Managing prediabetes would make it possible to defer the disease or even to revert to a healthy physiological state.

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Valedia®

Valedia® is a world premiere for 527 million prediabetics. The product entered Phase II in November 2016, and is designed to prevent type 2 diabetes.

Preclinical studies conducted on its active ingredient have proven its ability to:

  • Reduce fasting blood glucose;
  • Reduce glycated hemoglobin (HbA1c);
  • Improve insulin sensitivity;
  • Improve carbohydrate tolerance;
  • Reduce body weight (specific effect on body fat mass);
  • Reduce liver and blood triglycerides.

In Humans, the results of the Phase I/II clinical trial confirmed the safety of Valedia® and provided proof of concept on the metabolism of glucose and insulin, showing:

  • Increased carbohydrate tolerance with a 13% decrease in the postprandial glycemic peak;
  • A 37% decrease in postprandial insulin secretion;
  • A 41% improvement in the insulin sensitivity index, a key mechanism for preventing and treating type 2 diabetes.

The results of the Phase II studies, which included over 450 people from Europe, the United States and Canada, will provide key data to facilitate the submission of a proprietary health claim to European and American regulatory authorities. This claim will enable Valedia® to be positioned as the first product in the world designed for over 527 million prediabetics.

Valedia® is the first of a line of new-generation, first-in-class products that provide a true preventive solution. Valedia® enables patients to live life to the fullest, in good health, and it helps ease the economic burden placed on public and private health systems.

Oral Carbohydrate Tolerance Test
Glycemic peak

Evolution of postprandial blood glucose

Oral Carbohydrate Tolerance Test
Postprandial insulinemia