Efficacy and safety of sotagliflozin adjuvant therapy for type 1 diabetes mellitus

Abstract

Background: To systematically evaluate the efficacy and safety of sotagliflozin (SOTA) adjuvant therapy for type 1 diabetes mellitus (T1DM). Methods: Through April 2019, the Web of Science, PubMed, Cochrane Library, Embase, and China National Knowledge Infrastructure databases were electronically searched to identify randomized controlled trials exploring SOTA adjuvant therapy for T1DM. Strict screening and quality evaluations of the obtained literature were performed independently by 2 researchers. Outcome indexes were extracted, and a meta-analysis of the data was performed using Revman 5.3 software. Results: A total of 7 randomized controlled trials were included. The meta-analysis results showed that compared with the patients in the placebo group, the patients in the SOTA group had a lower hemoglobin A1c (mean difference [MD] = −0.28, 95% confidence interval [CI] [−0.34, −0.22], P < .01), lower total daily insulin use (MD = −8.89, 95% CI [−11.64, −6.13], P < .01), faster weight loss (MD = −3.03, 95% CI [−3.79, −2.26], P < .01), better fasting blood glucose and 2-hour postprandial blood glucose control (MD = −0.75, 95% CI [−1.04, −0.45], P < .01; MD = −2.42, 95% CI [−3.17, −1.67], P < .01), and a higher rate of well-controlled glucose levels (relative risk = 1.75, 95% CI [1.55, 1.99], P < .01), while no significant difference in the incidence of severe hypoglycemic events was found between the SOTA and placebo groups (risk difference [RD] = −0.01, 95% CI [−0.02, 0.00], P = .13). The incidence of diabetic ketoacidosis was higher in the SOTA group than in the placebo group (RD = 0.03, 95% CI [0.02, 0.04], P < .01). The incidence of genital mycotic infection was higher in the SOTA group than in the placebo group (RD = 0.06, 95% CI [0.05, 0.08], P < .01). No significant difference in the incidence of urinary tract infections was detected between the SOTA group and the placebo group (RD = 0.00, 95% CI [−0.01, 0.01], P = 0.97). Conclusions: SOTA is a potential drug for the treatment of T1DM and is effective for controlling blood sugar. The main adverse reactions to SOTA are genital mycotic infections and diabetic ketoacidosis. We must further assess the severity of diabetic ketoacidosis caused by SOTA.

Effect of sodium-dependent glucose transporter inhibitors on glycated hemoglobin A1c after 24 weeks in patients with diabetes mellitus

“…SOTA-related studies were not included in this study, so the drugs included in this study are all SGLT-2 inhibitors. [ 50 ] SGLT-2 inhibitors achieve the goal of blood sugar control by increasing the excretion of glucose from urine. [ 40 , 41 ]…”

Association of British Clinical Diabetologists (ABCD) and Diabetes UK joint position statement and recommendations on the use of sodium-glucose co-transporter inhibitors with insulin for treatment of type 1 diabetes (updated October 2020)

“…[30][31][32][33][34][35][36][37] In a recent meta-analysis including over 7000 participants and 17 randomised controlled trials (RCTs), SGLT inhibitor therapy significantly reduced HbA1c (4 mmol/mol (0.37%)) and body weight (2.88 kg). 38 In another meta-analysis of seven RCTs, lower HbA1c (−3 mmol/mol (−0.28%)), lower insulin dose (MD −0.89) and greater weight loss (−3.03) without any significant difference in hypoglycaemia 39 was seen in the sotagliflozin group.…”

“…44 Sotagliflozin meta-analysis of seven RCTs including nearly 3,600 participants showed a higher rate of DKA (RD 0.03) and genital mycotic infections (RD 0.06) but no increase in urinary tract infections compared with placebo. 39 People with type 1 diabetes develop DKA in the absence of insulin. Insulin helps reduce glucose but also prevents lipolysis.…”

Association of British Clinical Diabetologists (ABCD) and Diabetes UK joint position statement and recommendations on the use of sodium–glucose cotransporter inhibitors with insulin for treatment of type 1 diabetes (Updated October 2020)

“…In another meta‐analysis of 7 RCTs, lower HbA1c [−3 mmol/mol (−0.28%)], lower insulin dose (MD: −0.89) and greater weight loss (−3.03), without any significant difference in hypoglycaemia 39 was seen in the sotagliflozin group.…”

“…[30][31][32][33][34][35][36][37] In a recent meta-analysis including over 7000 participants and 17 randomised control trials, SGLT inhibitor therapy significantly reduced HbA 1c (4 mmol/mol [0.37%]) and body weight (2.88 kg). 38 In another meta-analysis of 7 RCTs, lower HbA1c [−3 mmol/mol (−0.28%)], lower insulin dose (MD: −0.89) and greater weight loss (−3.03), without any significant difference in hypoglycaemia 39 was seen in the sotagliflozin group.…”