Content of review 1, reviewed on July 26, 2020

In this brief report, Danne et al reported a post-hoc analysis of the InTandem RCTs that aimed to assess the efficacy and safety of sotagliflozin as adjunct therapy to insulin in patients with T1D and BMI > 27 kg/m2.

This paper is well-written and balanced and it is of interest for the clinicians since it offers a view on the target population selected by EMA.

I've only some minor comments and suggestions.

  1. It would be interesting to perform a sensitivity analysis in patients with grade 1 obesity cut-off (BMI > 30 kg/m2) in order to assess the benefit of SOTA in this population (since the median BMI in T1D with BMI > 27 kg/m2 is 32.0, we can expect a sufficient number of such patients to perform the analysis). This could be added as supplemental data.

  2. Beside SBP, it would be interesting also to show the results on diastolic BP.

  3. I suggest in the Table 1 to show the insuline dose by dose/kg rather than crude values since it's more indicative of insulin sensitivity.

  4. A brief definition of hypoglycemia (severe, confirmed, etc..) use in InTandem studies should be remind in the Methods section

  5. The apparent less efficacy of SOTA (at least 200 mg dose) on SBP in BMI > 27 group compared to control group should be discussed.

Source

    © 2020 the Reviewer.

Content of review 2, reviewed on October 09, 2020

I've no additional comments. The authors adequately responded to my queries.

Source

    © 2020 the Reviewer.

References

    Thomas, D., Steven, E., Pablo, F. J., Javier, A. F., Philip, B., Wenjun, J., J., D. M., Sangeeta, S. 2021. Efficacy and safety of adding sotagliflozin, a dual sodium-glucose co-transporter (SGLT)1 and SGLT2 inhibitor, to optimized insulin therapy in adults with type 1 diabetes and baseline body mass index ≥ 27 kg/m2. Diabetes, Obesity and Metabolism.