New oral diabetes drug shows promise in phase 3 trial for patients with type 1 diabetesSeptember 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.
University of Colorado Anschutz Medical Campus
Related Diabetes Articles:
There has been no known link between diabetes and vitamin A -- until now.
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.
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.
Social and economic factors have led to a dramatic rise in type 2 diabetes and obesity around the world.
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.
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.
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.
Although insulin-producing cells are found in the endocrine tissue of the pancreas, a new mouse study suggests that abnormalities in the exocrine tissue could cause cell non-autonomous effects that promotes diabetes-like symptoms.
A new study published in The Lancet Diabetes & Endocrinology journal suggests that reducing sugar content in sugar sweetened drinks (including fruit juices) in the UK by 40 percent over five years, without replacing them with any artificial sweeteners, could prevent 500,000 cases of overweight and 1 million cases of obesity, in turn preventing around 300,000 cases of type 2 diabetes, over two decades.
Women with gestational diabetes who consistently and continuously breastfeed from the time of giving birth are half as likely to develop type 2 diabetes within two years after delivery, according to a study from Kaiser Permanente published today in Annals of Internal Medicine.
Related Diabetes Reading:
Bright Spots & Landmines: The Diabetes Guide I Wish Someone Had Handed Me
by Adam Brown (Author), Kelly L. Close (Foreword)
Adam Brown’s acclaimed diaTribe column, Adam’s Corner, has brought life-transforming diabetes tips to over 1 million people since 2013. In this highly actionable guide, he shares the food, mindset, exercise, and sleep strategies that have had the biggest positive impact on his diabetes – and hopefully yours too! Bright Spots & Landmines is filled with hundreds of effective diabetes tips, questions, and shortcuts, including what to eat to minimize blood sugar swings; helpful strategies to feel less stressed, guilty, and burned out; and simple ways to improve exercise and... View Details
The End of Diabetes: The Eat to Live Plan to Prevent and Reverse Diabetes
by Dr. Joel Fuhrman (Author)
The New York Times bestselling author of Eat to Live and Super Immunity and one of the country’s leading experts on preventive medicine offers a scientifically proven, practical program to prevent and reverse diabetes—without drugs.
At last, a breakthrough program to combat the rising diabetes epidemic and help millions of diabetics, as well as those suffering with high blood pressure and heart disease. Joel Fuhrman, M.D. Research director of the Nutritional Research Foundation, shows you how to live a long, healthy, and happy life—disease free. He... View Details
The Diabetes Code: Prevent and Reverse Type 2 Diabetes Naturally
by Jason Fung (Author), Nina Teicholz (Foreword)
From acclaimed author Dr. Jason Fung, a revolutionary guide to reversing diabetes.... View Details
Dr. Neal Barnard's Program for Reversing Diabetes: The Scientifically Proven System for Reversing Diabetes Without Drugs
by Neal Barnard (Author)
Tackle diabetes and its complications for good with this newly updated edition of Dr. Neal Barnard's groundbreaking program.
Revised and updated, this latest edition of Dr. Barnard’s groundbreaking book features a new preface, updates to diagnostic and monitoring standards, recent research studies, and fresh success stories of people who have eliminated their diabetes by following this life-changing plan.
Before Dr. Barnard’s scientific breakthrough, most health professionals believed that once you developed diabetes, you were stuck with it—and could... View Details
Choose Your Foods: Food Lists for Diabetes
by American Diabetes Association (Author)
The standard for diabetes meal planning for over 60 years, this edition features updated carbohydrate, protein, and fat information for a wide variety of foods and beverages and replaces exchange terminology with choices. Includes tips on exercise, reading food labels, and a glossary of diabetes related terms. View Details
Diabetes For Dummies
by Alan L. Rubin (Author)
The straight facts on treating diabetes successfully
With diabetes now considered pandemic throughout the world, there have been enormous advances in the field. Now significantly revised and updated, this new edition of Diabetes For Dummies includes the latest information on diabetes medications and monitoring equipment, new findings about treating diabetes in the young and elderly, new ways to diagnose and treat long- and short-term complications, updated nutritional guidelines, new tools for measuring blood sugar and delivering insulin to the body, and much more.
There's... View Details
The Official Pocket Guide to Diabetic Food Choices
by American Diabetes Association ADA (Author)
Completely updated to match the newest edition of Choose Your Foods: Food Lists for Diabetes Meal Planning, this pocket-sized guide is now better and more complete than ever.
Every day and at every meal, millions of people use the food list system to plan meals, make healthier choices, and better estimate portions. This proven system is the most popular approach to diabetes meal planning and has been used by dietitians, diabetes educators, and millions of people with diabetes for more than 70 years. This portable version of the Food Lists takes all of the information from... View Details
What Do I Eat Now?: A Step-by-Step Guide to Eating Right with Type 2 Diabetes
by Patti B. Geil R.D. (Author), Tami A. Ross R.D. (Author)
Any person diagnosed with diabetes has one simple question: What do I eat now? When diagnosed with type 2 diabetes, doctors typically tell their patients to start eating healthy. But what does that mean? If figuring out what to eat seems like taking a test, here’s the solution, the American Diabetes Association book, What Do I Eat Now?. Written in clear, concise, and down-to-earth language that takes the mystery out of confusing nutrition recommendations, this indispensable guide can help readers make lasting changes in as little as a month. In only 4 weeks, readers can eat... View Details
Mayo Clinic The Essential Diabetes Book
by Mayo Clinic (Author)
More people than ever before have diabetes. The disease affects an estimated 21 million adults and children in the US and many people with the disease don't have it under control. Unlike years ago, you have a good chance of living an active and healthy life with diabetes - provided you work with your health-care team to take the necessary steps to control your blood sugar. This title covers: the pre-diabetes stage — taking charge to prevent diabetes; types of diabetes; symptoms and risk factors; treatments and strategies for managing your blood sugar; avoiding serious complications;... View Details
Diabetic Living Diabetes Meals by the Plate: 90 Low-Carb Meals to Mix & Match
by Diabetic Living Editors (Author)
An easy, graphic guide to planning delicious, diabetes-friendly meals This innovative, graphic cookbook offers the easiest and most flavorful way to build complete meals that are diabetes-friendly and delicious. Sidestepping complex programs that turn meal-planning into work, the 90 complete meals in Diabetes Meals by the Plate follow the Plate Method—a simple approach to eating the right foods in proper amounts by filling your plate with one half nonstarchy vegetables, one quarter protein, and one quarter starch. A clever photo style showing every meal in its three... View Details