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Posted by on Mar 22, 2019 in Diabetes mellitus | 0 comments

In a nutshell

The aim of this study was to examine the effects of sotagliflozin added to insulin on blood sugar levels in patients with type 1 diabetes (T1D). The main finding of the study was that sotagliflozin and insulin together improved blood sugar control in T1D.

Some background

The main treatment of T1D is insulin (the hormone that controls blood sugar levels). However, the side effects of insulin are weight gain and hypoglycemia (blood sugar going dangerously low). Therefore, it is difficult to maintain a balance between blood sugars going too high and too low. It is now suggested that adding other drugs to the treatment of T1D may improve blood sugar control, without increasing the risk of hypoglycemia. Hypoglycemia is defined as a blood sugar level of less than 3.9 mmol/L.

Sotagliflozin is a drug used in the treatment of type 2 diabetes (T2D). It is an SGLT-2 inhibitor. It works by preventing sugar from being taken back up into the body after it is filtered out of the blood in the kidney. Instead, the sugar is removed from the body in the urine. Recent studies have shown that sotagliflozin has improved the HbA1c (blood test measuring blood sugar levels over the past 3 months), lowered fasting blood sugar levels and helped with weight loss in T1D. Blood sugar target range is 3.9-10.0 mmol/L.

It is not known if a combination of sotagliflozin and insulin could improve the time spent in the target range (TIR), reduce hypoglycemia and reduce after-meal blood sugar levels in T1D.

Methods & findings

This study included 278 patients with T1D who were treated with insulin. Patients were randomized to receive either 200mg sotagliflozin, 400mg sotagliflozin or a placebo daily. Patients were treated for 24 weeks.

After 24 weeks, average TIR for patients treated with 400mg sotagliflozin was 64.2%. Average TIR for patients treated with 200mg sotagliflozin was 57.8% and patients treated with placebo had an average TIR of 51.6%.

Patients treated with both 400mg and 200 mg sotagliflozin spent, on average, 5.5% of the time with a blood sugar less than 3.9mmol/L, compared to 5.9% of the time in the placebo group. After-meal blood sugar levels were reduced by 1.9 in those treated with 200mg sotagliflozin and 2.8 in those treated with 400mg sotagliflozin compared to the placebo group.

The bottom line

The authors concluded that sotagliflozin and insulin combined increased time spent in blood sugar target range and reduced after-meal blood sugar levels, without increasing time spent with a blood sugar of less than 3.9mmol/L.

The fine print

This study was funded and conducted by Lexicon Pharmaceuticals Inc. and Sanofi, the developers of sotagliflozin.

Published By :

Diabetes Care

Date :

Mar 04, 2019

Original Title :

Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program.

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