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

Get a Free Diabetes Meal Plan

Get a free 7-Day Diabetes Meal Plan from Constance Brown-Riggs who is a Registered Dietitian-Certified Diabetes Educator and who is also a national spokesperson for the American Dietetic Association.

Just enter in your email below to download your free Diabetes Meal Plan.

By clicking Submit, you agree to send your info to InformationAboutDiabetes.com who may contact you with updates and information and we agree to use it according to our privacy policy.

More Articles

Limiting our intake of highly processed foods, and eating more whole and lightly processed fare can boost our nutrient and fiber intake, lower...

Chamomile tea has long been prized for its calming properties, but few people realize it’s also beneficial for glucose regulation. Traditionally,...

Today, the healing benefits of essential oils are more than the claims of ancient tradition and alternative medicine. They are increasingly the...

The different sugar content of fruits can be confusing when you are trying to manage your...

There is nothing close to a one-size-fits-all exercise program for those with diabetic peripheral neuropathy. The best general advice is to...

More Articles

Limiting our intake of highly processed foods, and eating more whole and lightly processed fare can boost our nutrient and fiber intake, lower...

With such a marked increase in the number of new diabetes cases, more people are wondering if type 1 diabetes...

Keeping your blood sugar levels under control can be tough. There are so many factors that can affect blood sugar, like exercise, food, illness,...

Today, the healing benefits of essential oils are more than the claims of ancient tradition and alternative medicine. They are increasingly the...

Stomach aches and other gastrointestinal pains can be signs of a bigger problem. One such problem for diabetics is gastroparesis, or delayed...

While some celebrities aren't quick to talk about living with diabetes, others are quite transparent and inspiring - acting as advocates for the...

People with diabetes are about twice as likely to experience heart disease as those without the condition, making cardiovascular health a critical...

All diabetics know that maintaining proper blood sugar levels is the lifeline...

Pilates is an exercise method proven to improve flexibility, strength, coordination, muscular stamina, balance, and posture. Many Pilates...

It can be difficult enough to get on stage and make a roomful of strangers laugh, but for comedians suffering from type 1 or type 2 diabetes,...

Most people with insulin-dependent diabetes use syringes and lancets every day. However, many of them do not know how to dispose of these...

Diabetes is a complex disease, affecting virtually every part of the body. The damage it does, to nerve endings, blood vessels, organs, and the...

People with type 1 and type 2 diabetes have successfully competed in the Olympic Games. Their amazing stories prove that diabetes is no match for...

Explaining diabetes to children can seem like a daunting task, but in reality, it is no more difficult than discussing anything else important....

If your child has diabetes, you want him or her to be safe while in school and to have the same educational opportunities as other children....