Oral Medication For Type 1 Diabetes Does Well In Phase 3 Trial
Sotagliflozin is an oral medication being investigated for use by type 1 diabetes patients. The drug is used with insulin and designed to improve blood sugar control without increasing severe hypoglycemic or ketoacidosis events.
In a recent phase 3 trial, sotagliflozin was given to 1,402 subjects, and outcomes were promising. Hemoglobin A1C readings improved, and the subjects had lower rates of confirmed severe hypoglycemia than the participants taking a placebo. Those on the new drug also experienced drops in blood pressure, and weight.
“If approved by the FDA, sotagliflozin may be the first oral drug that helps patients with type 1 diabetes in improving their glucose control without any weight gain or increase of severe hypoglycemia,” said Satish Garg, M.D., professor of medicine and pediatrics at the Barbara Davis Center for Diabetes, University of Colorado. “If long-term use continues to show similar metabolic improvements in patients with type 1 diabetes, it is likely that the long-term complications of diabetes would be significantly reduced.”
Sotagliflozin works by inhibiting two sodium-glucose transporters. One of the transporters regulates glucose uptake in the gut, and the other regulates glucose re-uptake in the kidneys. “This [sotagliflozin] would not be a replacement for insulin; it is an adjunctive therapy,” says Garg. “However, because it works in the gut and the kidneys, it doesn't require insulin to have an effect.”
The 24-week phase 3 study was a double-blind, randomized, placebo controlled trial involving people in 133 countries. Subjects included men, and non-pregnant women aged 18 and up treated via insulin pump, or injection. Those in the drug group took 400 mg of sotagliflozin per day; all subjects were required to self-monitor glucose levels.
Participants on sotagliflozin had more episodes of ketoacidosis, and more diarrhea, and genital mycotic infection than the placebo group, but less than one percent of participants left the trial owed to these effects.
Initial phase 3 results were published in the New England Journal of Medicine.
Source: Science Daily
Photo credit: Daniel Pink
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