

FOLLOWUS
1. 1Department of Endocrinology, Key Laboratory of Endocrinology of Ministry of Health, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;
2. 2Health Science Popularization Research Center, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China;
*Corresponding author Tel: 86-10-69155845, E-mail: pan20111111@163.com
Published Online:11 April 2017,
Published:2017-04
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Yang Yingying, Pan Hui, Wang Bo, et al. Efficacy and Safety of SGLT2 Inhibitors in Patients with Type 1 Diabetes: A Meta-analysis of Randomized Controlled Trials[J]. Chinese medical sciences journal, 2017, 32(1): 22-27.
Objective
To assess the efficiency and safety of a novel sodium-glucose co-transporter 2 (SGLT2) inhibitor—SGLT2 inhibitors
in combination with insulin for type 1 diabetes mellitus (T1DM).
Methods
We searched Medline
Embase
and the Cochrane Collaboration Library to identify the eligible studies published between January 2010 and July 2016 without restriction of language. The Food and Drug Administration (FDA) data and ClinicalTrials (http://www.clinicaltrials.gov) were also searched. The included studies met the following criteria: randomized controlled trials; T1DM patients aged between 18 and 65 years old; patients were treated with insulin plus SGLT2 inhibitors for more than 2 weeks; patients’ glycosylated hemoglobin (HbA1c) levels were between 7% and 12%. The SGLT2 inhibitors group was treated with SGLT2 inhibitors plus insulin
and the placebo group received placebo plus insulin treatment. The outcomes should include one of the following items: fasting blood glucose
HbA1c
glycosuria
or adverse effects. Data were analyzed by two physicians independently. The risk of bias was evaluated by using the Cochrane Collaboration’s Risk of Bias tool and heterogeneity among studies was assessed using Chi-square test. Random effect model was used to analyze the treatment effects with Revman 5.3.
Results
Three trials including 178 patients were enrolled. As compared to the placebo group
SGLT2 inhibitor absolutely decreased fasting blood glucose [mean differences (
MD
) -2.47 mmol/L
95% confidence interval (
CI
) -3.65 to -1.28
P
<
0.001] and insulin dosage (standardized MD -0.75 U
95%
CI
-1.17 to -0.33
P
<
0.001). SGLT2 inhibitors could also increase the excretion of urine glucose (
MD
131.09 g/24 h
95%
CI
91.79 to 170.39
P
<
0.001). There were no significant differences in the incidences of hyperglycemia [odds ratio (
OR
) 1.82
95%
CI
0.63 to 5.29
P
=0.27]
urinary tract infection (
OR
0.95
95%
CI
0.19 to 4.85
P
=0.95)
genital tract infection (
OR
0.27
95%
CI
0.01 to 7.19
P
=0.43)
and diabetic ketoacidosis (
OR
6.03
95%
CI
0.27 to 135.99
P
=0.26) between the two groups.
Conclusion
SGLT2 inhibitors combined with insulin might be an efficient and safe treatment modality for T1DM patients.
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