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.
- Garg SK, Henry RR, Banks P, et al. Effects of sotagliflozin added to insulin in patients with type 1 diabetes. NEJM. https://www.nejm.org/doi/full/10.1056/nejmoa1708337. Published December 14, 2017. Accessed July 4, 2018.
- Diabetes. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/diabetes. Published September 16, 2022. Accessed December 13, 2022.