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

September 13, 2017, CU Anschutz Medical Campus

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 control without any increase in severe hypoglycemia or 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 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 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 and the dose need," Garg said. "Patients in our study had lower weights, no 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 , including data on continuous glucose monitoring in future publications.

Explore further: Risks of diabetics fasting during Ramadan: Hypoglycemia rates with insulin pump v. injections

Related Stories

Risks of diabetics fasting during Ramadan: Hypoglycemia rates with insulin pump v. injections

April 7, 2017
A new study examining the risk of fasting during Ramadan for people with type 1 diabetes compared blood glucose control and the rates of hypoglycemia and hyperglycemia between users of insulin pump therapy versus multiple ...

Biosimilar insulin lispro shown not inferior to Humalog in efficacy or safety

August 9, 2017
A study comparing the safety and efficacy of SAR342434, a biosimilar (follow-on form) of insulin lispro-Humalog, found it to be comparable to that of the brand name drug in patients also using insulin glargine. The phase ...

Similar defects ID'd for T2DM, chronic pancreatitis and diabetes

August 2, 2017
(HealthDay)—Patients with type 2 diabetes and those with diabetes secondary to chronic pancreatitis have similarly impaired α-cell responses to oral glucose ingestion and hypoglycemia, according to a study published online ...

In T2D, glycemic control up with continuous glucose monitoring

August 23, 2017
(HealthDay)—Adults with type 2 diabetes receiving multiple daily insulin injections randomized to continuous glucose monitoring (CGM) have improved glycemic control versus usual care, according to a study published online ...

Lowest glucose variability for insulin + GLP-1 RA in T2DM

December 20, 2016
(HealthDay)—For patients with type 2 diabetes, the lowest glucose variability (GV) and hypoglycemia is seen for patients using basal insulin + glucagon-like peptide 1 receptor agonist (GLP-1 RA) (BGLP), according to a study ...

Studies compare types of insulin for reducing episodes of low blood sugar for patients with Type 1 or 2 diabetes

July 3, 2017
Treatment with the insulin degludec compared to glargine U100 for 32 weeks resulted in a reduced rate of hypoglycemic (low blood sugar) episodes among patients with type 1 or 2 diabetes and at least one risk factor for hypoglycemia, ...

Recommended for you

Researchers find existing drug effective at preventing onset of type 1 diabetes

February 15, 2018
A drug commonly used to control high blood pressure may also help prevent the onset of type 1 diabetes in up to 60 percent of those at risk for the disease, according to researchers at the University of Colorado Anschutz ...

Chemist designs diabetic treatment minus harmful side effects

February 9, 2018
A chemist in the College of Arts and Sciences (A&S) has figured out how to control glucose levels in the bloodstream without the usual side effects of nausea, vomiting or malaise.

Peptide improves glucose and insulin sensitivity, lowers weight in mice

February 8, 2018
Treating obese mice with catestatin (CST), a peptide naturally occurring in the body, showed significant improvement in glucose and insulin tolerance and reduced body weight, report University of California San Diego School ...

Study reports use of nutritional ketosis with mobile app intervention could reverse Type 2 diabetes

February 7, 2018
A newly published study has shown that an individualized approach to nutritional ketosis (utilizing fat rather than glucose to fuel the body), combined with remote monitoring via a mobile application, could sustainably and ...

Simple molecule could prevent, alleviate pre-diabetes

February 7, 2018
Restoring levels of coenzyme Q10 (CoQ), a key molecule in energy production in cells, could overcome insulin resistance or pre-diabetes—a precursor to type 2 diabetes and cardiovascular disease.

Brain scans show why some type 1 diabetics miss low blood sugar cues

February 2, 2018
The brains of people with type 1 diabetes react differently to low blood sugar compared with healthy adults, say Yale researchers.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.