Will a Pill for Type 2 Diabetes Help the Heart and Kidneys?
By Emma Ryan
A study recruiting 10,000 people will look at whether Zynquista (sotagliflozin) has effects beyond glucose-lowering and weight loss
Clinical Trials Identifier: NCT03315143
Trial name: Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED)
Diabetes type: Type 2
What the trial is testing: This study will test the effects of Zynquista (sotagliflozin), an SGLT-1/2 dual inhibitor, on heart health outcomes of people with type 2 diabetes who are at higher risk for heart disease and have moderate kidney disease. Zynquista is a once-daily pill that has been shown to aid A1C reduction and weight loss. It is under review by the FDA for people with type 1 diabetes, but may also help people with type 2 diabetes. Both the drug and healthcare provider visits will be free for study participants.
What the trial is measuring: In addition to heart attacks, strokes, and deaths from heart disease, the study will record the progression of kidney disease over time.
Why is this new/important?: People with type 2 diabetes are more likely to develop heart disease and kidney disease than people without diabetes. Beyond A1C-lowering and weight loss, SCORED will examine the impact of Zynquista on the heart or kidneys. We might expect a positive impact, given results for similar SGLT-2 inhibitor drugs currently available for type 2 diabetes. In a similar cardiovascular outcomes trial, Jardiance (empagliflozin) showed positive heart health outcomes, spurring the FDA to update the drug’s label. More recently, another SGLT-2 inhibitor, Invokana (canagliflozin), showed protection against kidney disease in people with type 2 diabetes. For healthcare providers and patients choosing among various type 2 diabetes drugs, these long-term outcomes are very important to know.
Trial length: The trial will follow up with participants for up to 51 months (about 4 years).
Trial locations: The study is recruiting over 10,000 participants in over 500 locations globally, including 30 states in the US. See a complete list here.
Do you qualify? Eligibility criteria include:
Type 2 diabetes with an A1C greater than 7%
An estimated glomerular filtration rate (eGFR) between 25 and 60 (approximately stage 3A and 3B of chronic kidney disease)
At least 18 years old with at least one major cardiovascular risk factor – e.g., high blood pressure, smoking
At least 55 years old with at least two minor cardiovascular risk factors – e.g., obesity, lack of regular exercise, stress
Where to get more information: Contact Sanofi at 800-633-1610, extension 1 then #, or at email@example.com.