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Type I Diabetes Trial Finds Hopeful Results

A trial investigated the effects of sotagliflozin with insulin therapy in controlling blood glucose levels in people living with type I diabetes mellitus (T1DM).1

A new era of improved control over blood glucose levels for patients with type I diabetes may be here. Insulin therapy controls blood glucose levels within a target range and is critical for T1DM. However, despite advances in therapeutics, preventing and managing hypoglycemia (low blood sugar/low blood glucose) remains a challenge.

A new diabetes discovery

A potential new pharmaceutical treatment called sotagliflozin inhibits two proteins responsible for regulating glucose. By inhibiting these proteins, there are improvements of glycemic control after meals and a reduction of glucose lost in urine. Sotagliflozin is the first dual-inhibitor studied in humans and has the potential to reduce the risk of low blood sugar.

Recently, the phase III inTandem3 clinical trial was conducted across 134 globally distributed sites. It included 1400 adults with type I diabetes who were using either an insulin pump or multiple-injection therapy.

Multiple injection therapy means the patient used one or two long-acting insulin injections along with rapid or short-acting insulin injections before each meal, over 24-hours. The study compared the safety and effectiveness of two different doses of sotagliflozin plus insulin therapy versus insulin therapy on its own.

The results: the good

After 52-weeks the effects of the different treatments were assessed. Researchers evaluated the safety of the drug and the changes in blood glucose levels and body weight. The participants receiving either of the 200mg or 400mg doses of sotagliflozin with insulin therapy had better control of blood glucose levels with a benefit of reduced body weight.

Additionally, the participants using sotagliflozin with insulin therapy lowered their total daily insulin dose compared to those only using insulin therapy. The reported adverse events from the study were 3.2% lower for the sotagliflozin group versus the group who did not use sotagliflozin.

The results: the bad

The researchers identified that inhibiting one of the proteins responsible for blood sugar management increased the risk of diabetic ketoacidosis.1 Diabetic ketoacidosis is a life-threatening complication of diabetes where the body produces high levels of blood acids.

There was a greater number of patients experiencing diabetic ketoacidosis in the groups taking sotagliflozin.1 However, the researchers noted that this increased risk of diabetic ketoacidosis could be managed with more monitoring and patient education.

The big picture

The inTandem3 trial suggests that patients receiving sotagliflozin wtih insulin therapy can better manage blood glucose levels. With millions worldwide living with T1DM,2 the inTandem3 results are promising for saving lives and improving health and quality of life.


  1. Garg SK, Henry RR, Banks P, et al. Effects of sotagliflozin added to insulin in patients with type 1 diabetes. NEJM. Published December 14, 2017. Accessed July 4, 2018.
  2. Diabetes. World Health Organization. Published September 16, 2022. Accessed December 13, 2022.
Lacey Hizartzidis PhD
Lacey Hizartzidis PhD
Lacey has a Ph.D. in Medicinal Chemistry from the University of Newcastle in Australia. Her research investigated the use of flow chemistry to synthesize potential anti-cancer agents. Having authored a number of articles published in international journals, she has developed a love for writing. Coupled with her passion for science and health, Lacey truly enjoys writing for Medical News Bulletin and helping people to understand the important and exciting scientific research being conducted around the world. With an adventurous spirit, Lacey also enjoys travelling the world, living a healthy life and helping others to do so as well.


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