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. 2018 Sep 12;9(5):1831–1851. doi: 10.1007/s13300-018-0496-z

Table 2.

Summary of the main findings of trials investigating the use of sodium glucose co-transporter type 2 inhibitors in type 1 diabetes

Perkins et al. [30] Pieber et al. [29] Tamez et al. [31] Sands et al. [32] Garg et al. [33] Dandona et al. (DEPICT trial) [35]
Year 2014 2015 2015 2015 2017 2017
Study design Single-arm, proof of concept study Placebo-controlled RCT with variable dosing Single-arm, proof of concept study Placebo-controlled RCT Placebo-controlled RCT Placebo-controlled RCT
Agent investigated Empagliflozin Empagliflozin Dapagliflozin Sotagliflozin Sotagliflozin Dapagliflozin
No. of participants 40 75 12 33 1402 833
Duration of study 8 weeks 28 days 24 weeks 29 days 24 weeks 24 weeks
Change in HbA1c (%) compared to placebo − 0.4 (p ≤ 0.0001)

2.5 mg empagliflozin

− 0.35 (− 0.62, − 0.09), p = 0.01

10 mg empagliflozin

− 0.38 (− 0.62, − 0.10), p = 0.008

25 mg empagliflozin

− 0.49 (− 0.75, − 0.22), p < 0.001

− 0.55% (p = 0.002) − 0.49 (p = 0.002) − 0.46 (p < 0.001)

5 mg dapagliflozin

− 0.48 (p < 0.0001)

10 mg dapagliflozin

− 0.46 (p < 0.0001)

Change in total daily insulin dose (units unless stated otherwise) − 8.9 (p < 0.0001)

2.5 mg empagliflozin

− 0.07 (− 0.14, 0.05), p = 0.044

10 mg empagliflozin

− 0.09 (− 0.16, 0.00), p = 0.013

25 mg empagliflozin

− 0.08 (− 0.15, − 0.01), p = 0.023

Not reported − 14.6% (p = 0.029) − 5.3 (p < 0.001)

5 mg dapagliflozin

− 6.79 (p < 0·0001)

10 mg dapagliflozin

− 7.24 (p < 0·0001)

Change in weight (kg) − 2.6 (p < 0.0001)

2.5 mg empagliflozin

− 1.5 (− 2.4, − 0.7), p < 0.001

10 mg empagliflozin

− 1.8 (− 2.7, −  0.9), p ≤ 0.001

25 mg empagliflozin

− 1.9 (− 2.7, − 1.0), p ≤ 0.001

Not reported − 2.2 (p = 0.005) − 2.98 (p < 0.001)

5 mg dapagliflozin

− 2.29 (p < 0·0001)

10 mg dapagliflozin

− 2.98 (p < 0·0001)

Adverse events reported

Improvement in rates of symptomatic hypoglycaemia reported

2 episodes of DKA, but as a result of insulin pump failure and gastrointestinal upset leading to withdrawal from trial

No significant increase in rates of hypoglycaemia reported between groups

No episodes of DKA reported in any group

No significant adverse events reported

Rates of hypoglycaemia among groups not numerically tested, but a decrease in hypoglycaemic events was observed in both groups

2 episodes of DKA in the sotagliflozin group, but was found to be pump-related by the study team

Increased rates of DKA in the sotagliflozin group (8.6% vs 2.4%), but statistical significance not commented on

Numerical increase in rates of hypoglycaemia in the sotagliflozin group, but statistical significance not commented on

No significant differences in rates of hypoglycaemia or DKA between either of the dapagliflozin groups and placebo