Sept. 13 (UPI) -- A Phase 3 clinical trial of the drug, sotagliflozin, show promise at helping to control glucose levels and reduce the need for insulin in type 1 diabetics.
Preliminary results of the trial by the University of Colorado Anschutz Medical Campus were published today in the New England Journal of Medicine.
Sotagliflozin is an investigational new oral drug for patients with type 1 diabetes to improve glucose control without any increase in severe hypoglycemia, or low blood sugar, or diabetic ketoacidosis compared to insulin alone.
Researchers found that of the 1,402 trial participants given sotagliflozin, the drug showed clinically meaningful and statistically significant effects on glucose control with improved A1C numbers compared to placebo after 24 weeks of treatment. Most patients struggle to achieve optimal blood glucose control with just insulin alone.
"Sotagliflozin added to insulin therapy can potentially help patients with type 1 diabetes improve their glucose control and hopefully manage the disease with fewer complications," Dr. Satish Garg, professor of medicine and pediatrics at the Barbara Davis Center for Diabetes at the Anschutz Medical Campus, said in a press release. "This would not be a replacement for insulin; it is an adjunctive therapy. However, because it works in the gut and the kidneys, it doesn't require insulin to have an effect."
Sotagliflozin would be used in conjunction with insulin and researchers found that participants taking the drug orally along with traditional insulin treatments had significant improvements in glucose control, a drop in systolic and diastolic blood pressure and weight loss.
"Sotagliflozin may reduce the bad effects of insulin and the dose patients need," Garg said. "Patients in our study had lower weights, no severe hypoglycemia and better blood pressure."