Will a Pill for Type 2 Diabetes Help the Heart and Kidneys?
By Emma Ryan
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 protected].
