Committed to Improving the Lives of People with Diabetes

Forging a New Path
in Diabetes Care

vTv Therapeutics (vTv) is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, currently in a Phase 3 trial, a potential first-in-class oral liver-selective glucokinase activator being investigated for the treatment of type 1 diabetes (T1D)*.

// Unmet Need

Obstacles on the Path to Glucose Management

Despite major advances in medical devices used to help manage blood glucose levels in people living with T1D, there have been few therapeutic advances in the past 100 years. To date, there has never been an FDA-approved oral adjunctive therapy to insulin for the 1.5M Americans living with T1D.1

Approximately 75% of people living with T1D in the US do not maintain the HbA1c blood glucose target (< 7%)2 recommended by the American Diabetes Association. The majority experience frequent episodes of hypoglycemia, which can be life-disruptive, and in severe cases may be life-threatening.3 Even with current technologies such as CGM and AID systems, recent data shows most people with T1D have several mild to moderate episodes of hypoglycemia each week4 and ~20% experience at least one severe episode in a 12-month period.5

Importantly, hypoglycemia is often the major limiting factor in glycemic management for people living with T1D. The fear of hypoglycemia often leads people to reduce insulin, skip injections, or snack continuously to maintain higher blood glucose levels. These avoidance behaviors may increase periods of hyperglycemia and raise the risk of long-term health complications.6

// Cadisegliatin

Focusing Innovation Where It Matters

To help people with T1D navigate the highs and lows of blood glucose management, vTv Therapeutics is focused on developing cadisegliatin, an oral liver-selective glucokinase activator that, if approved, may become the first FDA-approved oral adjunctive therapy to insulin to treat T1D. Cadisegliatin is designed to help the body’s natural glucose regulation system in the liver function more effectively, potentially offering a novel approach to blood glucose management.

*Cadisegliatin is under investigation and the safety and efficacy has not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated.

References

  1. Breakthrough T1D. (2024, July 29). Incidence and Prevalence. Breakthrough T1D. https://www.breakthrought1d.org/t1d-basics/incidence-prevalence/
  2. Ebekozien, O., et al. (2023). Longitudinal Trends in Glycemic Outcomes and Technology Use for Over 48,000 People with Type 1 Diabetes (2016–2022) from the T1D Exchange Quality Improvement Collaborative. Diabetes Technology & Therapeutics, 25(11), 765–773. https://doi.org/10.1089/dia.2023.0320
  3. American Diabetes Association. (n.d.). Severe Hypoglycemia. American Diabetes Association. https://diabetes.org/living-with-diabetes/hypoglycemia-low-blood-glucose/severe
  4. Breakthrough T1D. (n.d.). Low Blood Sugar (Hypoglycemia). Breakthrough T1D. https://www.breakthrought1d.org/t1d-basics/symptoms/low-blood-sugar/
  5. Sherr, J. L., et al. (2024). Severe Hypoglycemia and Impaired Awareness of Hypoglycemia Persist in People With Type 1 Diabetes Despite Use of Diabetes Technology: Results From a Cross-sectional Survey. Diabetes Care47(6), 941–947. https://doi.org/10.2337/dc23-1765
  6. American Diabetes Association. (n.d.). Fear of hypoglycemia (and other diabetes-specific fears). In Diabetes and Emotional Health Workbook: A practical guide for health professionals supporting adults with type 1 and type 2 diabetes. American Diabetes Association. https://professional.diabetes.org/professional-development/behavioral-mental-health/MentalHealthWorkbook