Imeglimin, a novel compound being developed to treat Type 2 diabetes, showed increasing effectiveness as an add-on therapy to sitagliptin, in patients inadequately controlled by sitagliptin monotherapy, in a Phase II trial conducted by Poxel SA.

The study accomplished its main endpoint of superiority in blood sugar levels (HbA1c) reduction, compared to a placebo. The reduction seen in Fasting Plasma Glucose (FPG) was also significant. The decrease in HbA1c and FPG are critical in controlling diabetes.

The Phase II study analyzed the advantages of adding imeglimin to sitagliptin in 150 subjects. Results from the trial showed that patients treated with imeglimin-sitagliptin therapy saw 0.73% decrease in HbA1c after 12 weeks, compared to the placebo group.

The imeglimin-sitagliptin therapy, which showed great tolerability and safety, was more beneficial to patients than the sitagliptin-placebo treatment.

Professor Valdis Pirags, Principal Investigator, said:

“I am pleased to see this study meeting its end-points. Imeglimin is effective as add-on therapy to sitagliptin with a great safety/tolerability profile. Combinability associated to safety is essential for new products to tackle type 2 diabetes.”

The treatment showed impressive results in this study, said Professor Harold Lebovitz, a prominent member of Poxel’s scientific advisory board. “They do confirm the attractiveness of Imeglimin for both regulators and future prescribers: the molecule is unique and demonstrates its great efficacy potential in monotherapy as in combination with the two most important molecules on the treatment armamentarium today, metformin and sitagliptin”.

Thomas Kuhn, CEO of Poxel concluded:

“In just two years since our first round of financing, the Company has now completed two successful phase II clinical trials with Imeglimin. This second positive clinical trial demonstrates Imeglimin’s potential to complement the efficacy of major drugs, which brings further value to our compound and added confidence in its further development. Within the type 2 diabetes landscape, Imeglimin is ahead in a race where new entrants have yet to prove their efficacy, their combinability and their safety.”

Imeglimin is the first in a new group of anti-diabetic prototypes, the glimins.

Imeglimin affects three organs involved in glucose homeostasis:

  • liver
  • pancreas
  • muscle

This behavior is what makes Imeglimin unique from other existing treatments for Type 2 diabetes, and therefore, the best component to add to other therapies.

The first phase II trial, Imeglimin phase 2a monotherapy, was published in April in 2012 in Diabetes, Obesity, and Metabolism. Poxel announced phase 2 results of Imeglimin as add-on therapy to metformin in patients inadequately controlled with metformin monotherapy, in October 2011. This research accomplished its main end-point of superiority in HbA1c reduction compared to a placebo. The results were demonstrated in Philadelphia last June in a poster during the 73rd edition of the American Diabetes Association meeting, and it will be published in Diabetes Care.

The most prevalent type of diabetes is Type 2 diabetes. Although it is normally seen in adults, there is an elevating number of children and adolescents affected by the disease.

With this type, the body is capable of producing insulin, but it is just not enough or the body cannot react to its impact, causing the blood to have a build-up of glucose.

Cardiovascular and kidney diseases are likely to develop from Type 2 diabetes. The disease is affecting an increasing number of people around the world. Scientists believe that the rise is due to:

  • increasing urbanization
  • economic development
  • dietary changes
  • aging populations
  • decreased physical activity
  • changes in other lifestyle patterns

The International Diabetes Federation estimated 366 million people worldwide to have diabetes in 2011, and according to them, that number will increase to 552 million in 2030. An additional 7 million people develop diabetes each year.

Since today’s market is made up of only a few product classes, there are a significant amount of needs still not met for both doctors and patients.

The worldwide pharmaceutical market for Type 2 diabetes is currently made up of 60% oral anti-diabetics. The market is estimated to almost double from $26 billion in 2011 to $48.8 billion in 2021.

Written by Sarah Glynn