Nav: Home

New oral diabetes drug shows promise in phase 3 trial for patients with type 1 diabetes

September 13, 2017

A University of Colorado Anschutz Medical Campus study finds sotagliflozin helps control glucose and reduces the need for insulin in patients with type 1 diabetes.

Principal results were published today in the New England Journal of Medicine of a global Phase 3 clinical trial in patients with type 1 diabetes treated with sotagliflozin. Sotagliflozin is an investigational new oral drug for patients with type 1 diabetes that has shown promise in improving glucose control without any increase in severe hypoglycemia or diabetic ketoacidosis compared to insulin alone.

Among 1,402 trial participants given the drug, sotagliflozin showed clinically meaningful and statistically significant effects on glucose control. Concentrations of hemoglobin A1C, a measure of plasma glucose, were improved. Patients experienced a lower rate of confirmed severe hypoglycemia than observed in patients on placebo and also had weight loss.

According to lead investigator Satish Garg, MD, professor of medicine and pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, no oral medication has ever been approved for the treatment of type 1 diabetes and sotagliflozin has the potential to become the first new treatment innovation in nearly a century since insulin.

Most patients do not achieve optimal glycemic control with insulin alone. A1C concentrations, hypertension and reduction in body weight are critical issues which significantly impact people living with type 1 diabetes.

"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 and severe hypoglycemia," Garg said. "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 would be used in conjunction with insulin. Trial participants taking the drug as an oral pill alongside traditional insulin treatments experienced significant improvements in glucose control, a drop in systolic and diastolic blood pressure and weight loss.

Sotagliflozin is a unique dual inhibitor that works by inhibiting two sodium-glucose transporters: SGLT1 and SGLT2. Each modulates glucose levels. SGLT1 regulates the uptake of glucose in the gut while SGLT2 regulates the re-uptake of glucose in the kidney, according to the authors.

"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," Garg said. "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."

The inTandem3 study was a double-blind, placebo controlled and randomized Phase 3 trial including adults with type 1 diabetes at 133 sites worldwide. In conjunction with this publication, the data were announced today at the 53rd Annual Meeting of the European Association Study for Diabetes in Lisbon, Portugal.

The 24-week trial evaluated the safety and efficacy of sotagliflozin at 400mg per day in randomized patients treated with any insulin regimen - pumps or injections. Eligible patients included men and nonpregnant women aged 18 and older, and they were required to self-monitor blood glucose.

The study met its primary endpoint with statistical significance, demonstrating the superiority of sotagliflozin 400 mg compared to placebo in the proportion of patients with A1C less than seven percent at week 24, no episode of severe hypoglycemia and no episode of diabetic ketoacidosis after randomization.

The outcome on every secondary endpoint favored sotagliflozin over placebo, achieving statistical significance for all four secondary endpoints, including change from baseline in A1C, body weight, systolic blood pressure in patients with baseline SBP less than or equal to 130 mm Hg and bolus insulin dose. Sotagliflozin significantly reduced A1C compared to placebo after 24 weeks of treatment.

"As is known with sodium glucose cotransporter 2 (SGLT2) inhibitors, patients experienced more episodes of diabetic ketoacidosis in the trial," Garg said.

Diarrhea and genital mycotic infection also affected participants more than placebo, but less than one percent discontinued the study due to these effects.

"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."

Garg is a faculty member at the University of Colorado School of Medicine at the Anschutz Medical Campus and is editor in-chief of Diabetes Technology and Therapeutics Journal.

Garg and his colleagues are working to publish more results on other inTendem1 and 2 phase 3 clinical trials in type 1 diabetes, including data on continuous glucose monitoring in future publications.
-end-
The University of Colorado Anschutz Medical Campus is the only comprehensive academic health sciences center in Colorado, the largest academic health center in the Rocky Mountain region and one of the newest education, research and patient care facilities in the world. Home to 21,000 employees, more than 4,000 degree-seeking students and two nationally recognized hospitals that handle 1.7 million patient visits each year, CU Anschutz trains the health sciences workforce of the future and fuels the economy. CU Anschutz features schools of medicine, pharmacy, dental medicine and public health, a college of nursing and a graduate school. All interconnected, these organizations collaboratively improve the quality of patient care they deliver, research they conduct, and health professionals they train.

University of Colorado Anschutz Medical Campus

Related Diabetes Articles:

Maternal gestational diabetes linked to diabetes in children
Children and youth of mothers who had gestational diabetes during pregnancy are at increased risk of diabetes themselves, according to new research published in CMAJ (Canadian Medical Association Journal).
Two diabetes medications don't slow progression of type 2 diabetes in youth
In youth with impaired glucose tolerance or recent-onset type 2 diabetes, neither initial treatment with long-acting insulin followed by the drug metformin, nor metformin alone preserved the body's ability to make insulin, according to results published online June 25 in Diabetes Care.
People with diabetes visit the dentist less frequently despite link between diabetes, oral health
Adults with diabetes are less likely to visit the dentist than people with prediabetes or without diabetes, finds a new study led by researchers at NYU Rory Meyers College of Nursing and East Carolina University's Brody School of Medicine.
Diabetes, but not diabetes drug, linked to poor pregnancy outcomes
New research indicates that pregnant women with pre-gestational diabetes who take metformin are at a higher risk for adverse pregnancy outcomes -- such as major birth defects and pregnancy loss -- than the general population, but their increased risk is not due to metformin but diabetes.
New oral diabetes drug shows promise in phase 3 trial for patients with type 1 diabetes
A University of Colorado Anschutz Medical Campus study finds sotagliflozin helps control glucose and reduces the need for insulin in patients with type 1 diabetes.
Can continuous glucose monitoring improve diabetes control in patients with type 1 diabetes who inject insulin
Two studies in the Jan. 24/31 issue of JAMA find that use of a sensor implanted under the skin that continuously monitors glucose levels resulted in improved levels in patients with type 1 diabetes who inject insulin multiple times a day, compared to conventional treatment.
Complications of type 2 diabetes affect quality of life, care can lead to diabetes burnout
T2D Lifestyle, a national survey by Health Union of more than 400 individuals experiencing type 2 diabetes (T2D), reveals that patients not only struggle with commonly understood complications, but also numerous lesser known ones that people do not associate with diabetes.
A better way to predict diabetes
An international team of researchers has discovered a simple, accurate new way to predict which women with gestational diabetes will develop type 2 diabetes after delivery.
The Lancet Diabetes & Endocrinology: Older Americans with diabetes living longer without disability, US study shows
Older Americans with diabetes born in the 1940s are living longer and with less disability performing day to day tasks than those born 10 years earlier, according to new research published in The Lancet Diabetes & Endocrinology journal.
Reverse your diabetes -- and you can stay diabetes-free long-term
A new study from Newcastle University, UK, has shown that people who reverse their diabetes and then keep their weight down remain free of diabetes.
More Diabetes News and Diabetes Current Events

Top Science Podcasts

We have hand picked the top science podcasts of 2019.
Now Playing: TED Radio Hour

Risk
Why do we revere risk-takers, even when their actions terrify us? Why are some better at taking risks than others? This hour, TED speakers explore the alluring, dangerous, and calculated sides of risk. Guests include professional rock climber Alex Honnold, economist Mariana Mazzucato, psychology researcher Kashfia Rahman, structural engineer and bridge designer Ian Firth, and risk intelligence expert Dylan Evans.
Now Playing: Science for the People

#540 Specialize? Or Generalize?
Ever been called a "jack of all trades, master of none"? The world loves to elevate specialists, people who drill deep into a single topic. Those people are great. But there's a place for generalists too, argues David Epstein. Jacks of all trades are often more successful than specialists. And he's got science to back it up. We talk with Epstein about his latest book, "Range: Why Generalists Triumph in a Specialized World".
Now Playing: Radiolab

Dolly Parton's America: Neon Moss
Today on Radiolab, we're bringing you the fourth episode of Jad's special series, Dolly Parton's America. In this episode, Jad goes back up the mountain to visit Dolly's actual Tennessee mountain home, where she tells stories about her first trips out of the holler. Back on the mountaintop, standing under the rain by the Little Pigeon River, the trip triggers memories of Jad's first visit to his father's childhood home, and opens the gateway to dizzying stories of music and migration. Support Radiolab today at Radiolab.org/donate.