Sanofi-Aventis Korea said it would start phase-3 clinical trials (SAR439954) in Korea to check safety and tolerability of Sotagliflozin, a treatment for type-2 diabetes inhibiting SGLT (sodium-glucose transport proteins) 1 and 2.
The Ministry of Food and Safety granted the nod for the study plan on Wednesday.
The trials will be randomized, double-blind, placebo-controlled, parallel arm, and multi-center in hemodynamically stable patients with worsening heart failure.
In other words, the study will assess safety, tolerability, and pharmacodynamic activity of Sotagliflozin in patients who went stable after worsening heart failure.
The multi-country trials will be on 50 domestic patients hospitalized in Seoul National University Hospital and Hallym University Dongtan Sacred Heart Hospital.
Sanofi has obtained four approvals for Sotagliflozin in Korea to date. In April last year, the company received the green light for a phase-3 study on adding Sotagliflozin to sulfonylurea monotherapy or combo therapy of sulfonylurea and metformin.
In December, Sanofi was allowed to test Sotagliflozin’s effect on cardiovascular and renal events in type-2 diabetic patients with cardiovascular risk factors and moderate renal insufficiency. In February, the drugmaker received the nod to conduct a 26-week study on the agent’s efficacy and bone safety in type-2 diabetic patients aged 55 or more with difficulty in blood sugar control.
Sotagliflozin is a double inhibitor of SGLT 1 and SGLT 2. SGLT 1 inhibition interferes with glucose uptake in the intestine and reduces blood glucose after meals. SGLT 2 inhibition lowers blood sugar by inhibiting glucose reabsorption in the kidneys.
In March, Sanofi submitted the marketing authorization application to the European Medicines Agency and the U.S. Food and Drug Administration to use Sotagliflozin with insulin to control blood glucose in type-1 diabetic adults.
The application was based on the results of phase-3, placebo-controlled clinical trials in 1,402 patients with type-1 diabetes.
The study results showed that Sotagliflozin-treated patients had a significant efficacy, compared to the placebo group. The Sotagliflozin group’s glycated hemoglobin level was less than 7 percent at the 24th week and did not experience severe hypoglycemia or diabetic ketoacidosis.
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