Sanofi has announced that its joint SGLT1/SGLT2 inhibitor with Lexicon, Zynquista (sotagliflozin), has been approved in Europe for certain patients with type I diabetes.
The approval is for adjunct use to insulin therapy to improve blood sugar (glycemic) control in adults with type I diabetes mellitus and a body mass index of 27 kg/m2 or more, who could not achieve adequate glycemic control despite optimal insulin therapy.
The authorisation is based on evidence including data from the inTandem clinical trial program, which included three Phase III clinical trials assessing the safety and efficacy of the drug, involving approximately 3,000 adults with inadequately controlled T1D.
The trial found that there were consistent and significant reductions from baseline at 24 weeks in average blood sugar, body weight, systolic blood pressure, a significant improvement of time in target blood sugar range and improved patient-reported outcomes compared to insulin alone.
“Millions of people across Europe who live with type I diabetes struggle to control their blood sugar, even with optimal insulin therapy,” commented Thomas Danne, Professor of Pediatrics, Children’s Hospital ‘Auf der Bult,’ Hannover, Germany. “For the many people living with type I diabetes who are overweight or obese, Zynquista will offer a new treatment option physicians can now consider in combination with insulin therapy for appropriate patients.”
Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2, which are responsible for glucose absorption in the gastrointestinal tract, and glucose reabsorption by the kidney, respectively.