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Exploring the effect of SGLT inhibition on kidney function
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Sanofi Diabetes Update:

For use with Ex-US media only


Background: Exploring the effect of SGLT inhibition on kidney function

June 8, 2018 – San Francisco, Calif., United States (U.S.)


As diabetes progresses, it increases the risk of life-threatening conditions, including renal complications1 It is commonly thought that up to 40% of people living with type 1 diabetes (T1D) will develop diabetic kidney disease (DKD), with a recent report suggesting that over the course of 50 years it could affect nearly 90% of patients.2 In addition to potentially progressing to end-stage renal disease, requiring kidney transplant or long-term dialysis, DKD also directly increases the risk of cardiovascular (CV) disease. Each of these comorbidities has a substantial impact on outcomes and overall cost of care, as well as makes it more complex to manage diabetes effectively.3

Decline in kidney function as DKD progresses is measured by several parameters, such as progressive decrease in estimated glomerular filtration rate (eGFR) and increase in urinary albumin to creatinine ratio (UACR).4 In adults with type 2 diabetes, selective SGLT2 inhibitors have established to reduce the risk of DKD progression in people with or without established CV disease.5-8

To further explore the impact that the dual inhibition of SGLT1 in addition to SGLT2 might have on kidney function in people living with T1D, Sanofi, and its development partner Lexicon Pharmaceuticals, presented a new analysis at the American Diabetes Association (ADA) 79th Scientific Sessions in San Francisco, Calif., U.S.9


Sotagliflozin* showed beneficial effect on cardio-renal clinical parameters in adults with type 1 diabetes


In a pooled analysis9 of 1,575 participants of the inTandem1 and 2 phase 3 clinical trials conducted in the U.S. and Europe,10,11 sotagliflozin lowered blood pressure and induced mild hemoconcentration, and was associated with short- and long-term changes in eGFR and a decline in albuminuria.

This overall profile suggests that dual SGLT1 and 2 inhibition may confer cardio-renal protection in analogous ways to selective SGLT2 inhibition in people with T1D and T2D,” said Dr. David Cherney, Associate Professor, Department of Medicine & Division of Nephrology, University of Toronto, Canada. “This analysis suggests that further studies should investigate the cardio-renal effects of sotagliflozin.

Sotagliflozin has a distinct dual mechanism of action, inhibiting SGLT1 in addition to SGLT2, so it is important to explore its effect on diabetic kidney disease,” said Rachele Berria MD, PhD, Global Vice President, Head of Diabetes, Sanofi Medical. “Our SCORED study is underway to evaluate how this dual mechanism translates to renal and cardiovascular outcomes in people with type 2 diabetes, as part of our extensive program of 11 clinical trials in this population.


Summary of analysis

This new pooled analysis9 combines data from the inTandem110 and inTandem211 Phase 3 clinical trials to evaluate 1,575 adults with insufficiently-controlled T1D. Participants were treated with sotagliflozin (200 mg or 400 mg) added to optimized insulin, or with optimized insulin only.

At baseline, participants had an eGFR of 89.30 ± 0.86 mL/min/1.73m2, signifying normal kidney function. After 4 weeks, there was an anticipated initial “dip” in eGFR in both sotagliflozin groups, (-2.5 and -2.8 mL/min/1.73m2 [SE 0.6, p < 0.0001]) in the 200-mg and 400-mg dose groups vs. placebo). However, from Week 4 to 52, although lower than placebo, eGFR tended to return toward baseline. At 52 weeks, eGFR change from baseline was -2.0 (SE 0.8, p = 0.010) and -0.5 mL/min/1.73m2 (SE 0.8, p = 0.52) for sotagliflozin 200 mg and 400 mg vs. placebo, respectively.

After 52 weeks, blood pressure was significantly lower with both doses of sotagliflozin, particularly in the hypertensive group at baseline. In patients with systolic blood pressure ≥ 130 mmHg, the difference at week 52 vs. patients treated with optimized insulin alone was -2.7 ± 0.77 mmHg (p=0.0005) for sotagliflozin 200 mg and -3.73 ± 0.77 mmHg (p<0.0001) with sotagliflozin 400 mg. Similarly, in the group with diastolic blood pressure


≥ 80mmHg at baseline, difference from optimized insulin alone group was -2.28 ± 0.83 (p=0.0005) with sotagliflozin 200 mg and -2.08 ± 0.86 mmHg (p<0.0001) with sotagliflozin 400 mg.


Sotagliflozin is approved only in Europe as adjunct to insulin to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy and is not currently approved for use in any other markets, where it is considered an investigational product.


References

1.        Chase HP, et al. JAMA 1989;261(8):1155-60, DOI: 10.1001/jama.1989.03420080075034.

2.        Costacou T, et al. Diabetes Care. 2018;41(3):426-33, DOI: 10.2337/dc17-1118.

3.        Nichols GA, et al. Diabetes Care. 2011;34(11):2374-8, DOI: 10.2337/dc11-0475.

4.        Mogensen CE. Diabetologia. 1999;42(3):263-85, DOI: 10.1007/s001250051151

5.        Wanner C, et al. New England Journal of Medicine. 2016;375(4):323-34, DOI:

10.1056/NEJMoa1515920.

6.        Perkovic V, et al. The Lancet Diabetes & Endocrinology. 2018;6(9):691-704, DOI:

10.1016/S2213-8587(18)30141-4.

7.        Perkovic V, et al. New England Journal of Medicine. 2019 Online ahead of print, DOI: 10.1056/NEJMoa1811744.

8.        Wiviott SD, et al. N Engl J Med. 2019;380(4):347-57, DOI: 10.1056/NEJMoa1812389.

9.        Cherney D et al. Presentation at American Diabetes Association (ADA) 79th Scientific Sessions, San Francisco, CA, U.S. June 9, 2019.

10.     Buse JB et al. Diabetes Care Jun 2018, dc180343; DOI: 10.2337/dc18-0343.

11.     Danne T et al. Diabetes Care Sep 2018, 41 (9) 1981-1990; DOI: 10.2337/dc18-0342.


Global Diabetes Communications

Emily Dell


Tel.: +1 (0) 908-239-4622

emily.dell@sanofi.com

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