The Challenge: Balancing Diabetes Control and Hypoglycemia Risk

High glucose increases long-term complications1, 2:

  • Less than 1/3 of diabetes patients achieve glucose targets
  • 1 in 3 T1D patients keep their glucose artificially high to avoid hypoglycemia
  • Loss of ~13 years of life expectancy
  • Most common cause of blindness, kidney failure, and lower limb amputations

Low glucose increases short term hypoglycemia risk1, 2:

  • ~1.4M emergency hospital visits/hospitalizations per year (USA)4
  • Continuous Glucose Monitoring reveals that hypoglycemia is an almost daily occurrence
  • Almost every person with T1D will have a 1-2 severe hypoglycemic events per year
  • 4% -10% of deaths in T1D are attributed to acute hypoglycemia3
challenge

Sources:

    1. http://www.nejm.org/doi/full/10.1056/NEJMoa1408214#t=article
    2. https://www.nejm.org/doi/full/10.1056/Nejmoa1003795
    3. Klonoff, et al. 2017
    4. Senior author Elizabeth Selvin, Ph.D., a professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health in Baltimore, March, 2017

The Idea

A titratable, fixed-ratio combination of two well-understood and FDA approved peptides to control glycemia while mitigating the threat of hypoglycemia. A Smart solution that fits well with current and future pharmacological and device platforms.

Alan Cherrington PhD, a well respected researcher at Vanderbilt University, discovered that it is feasible to deliver insulin and glucagon together in a fixed concentration ratio. It is known that the actions of the two peptides are opposing: insulin lowers blood glucose while glucagon raises blood glucose (and is the foundation for emergency rescue from hypoglycemia). His discovery is founded on the observation that the actions of insulin and glucagon, when given together, are glucose dependent. The hormones act in concert for improved glycemic control and protection from hypoglycemia when co-administered at a critical concentration ratio.

See the ADA 2020 Late Breaker Presentation

The Medical Need

Insulin replacement therapy involves multiple daily insulin injections or the delivery of insulin by a pump, the need for careful blood glucose monitoring, and the fear of an unwanted fall in blood glucose (hypoglycemia). Fear of hypoglycemia prevents optimal glycemic management leading to long term hyperglycemia and damage to the body (kidney, heart, extremities).

The Promise

Patients who use the Abvance combination product, in place of insulin alone, will be able to experience improved blood glucose control with a safety buffer against hypoglycemia. This would not require some new behavioral change or device enablement, and will lighten the daily burden of their disease management.

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