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Effect of exenatide twice daily and dapagliflozin, alone and in combination, on markers of kidney function in obese patients with type 2 diabetes: A prespecified secondary analysis of a randomized controlled clinical trial

van Ruiten, Charlotte C., van der Aart‐van der Beek, Annemarie B, IJzerman, Richard G., Nieuwdorp, Max, Hoogenberg, Klaas, van Raalte, Daniël H, Heerspink, Hiddo J. L.·2021·Diabetes, Obesity and Metabolism
DOI 10.1111/dom.14410PMC PMC8360098
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Abstract

Aims: To evaluate the effects of separate and combined use of the sodium‐glucose cotransporter‐2 (SGLT2) inhibitor dapagliflozin and the glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) exenatide on measures of kidney function. Methods: In this prespecified secondary analysis of the DECREASE trial, we enrolled 66 obese patients with type 2 diabetes in a 16‐week randomized double‐blind placebo‐controlled clinical trial to investigate the effects of dapagliflozin and exenatide twice daily, alone or in combination, versus placebo on 24‐hour urinary albumin:creatinine ratio (UACR), creatinine and cystatin C‐estimated glomerular filtration rate (GFR) and kidney injury molecule‐1:creatinine ratio (KIM‐1:Cr). Results: At week 16, the mean UACR change from baseline was −39.6% (95% confidence interval [CI] −58.6, −11.9; P = 0.001) in the combined exenatide‐dapagliflozin group, −18.1% (95% CI −43.1, 18.0; P = 0.278) in the dapagliflozin group, −15.6% (95% CI −41.4, 21.6; P = 0.357) in the exenatide group and − 11.0% (95% CI −39.8, 31.5; P = 0.552) in the placebo group. Compared to placebo, UACR difference at week 16 in the exenatide‐dapagliflozin group was −32.2% (95% CI −60.7, 16.9; P = 0.159). Effects were similar in 37 participants who were using angiotensin‐converting enzyme inhibitors or angiotensin receptor blockers at baseline. Compared to placebo, in the exenatide‐dapagliflozin group, an acute dip in estimated GFR was observed with creatinine‐estimated GFR (−4.0 mL/min/1.73 m 2 [95% CI −9.3, 1.2]; P = 0.129) and cystatin C‐estimated GFR (−10.4 mL/min/1.73 m 2 [95% CI −14.9, −5.8]; P < 0.001). The mean KIM‐1:Cr difference in the combined treatment arm versus placebo was −43.8% (95% CI −73.5, 18.9; P = 0.129). Conclusion: This prespecified secondary analysis suggests that combined therapy with exenatide and dapagliflozin may have synergistic effects on markers of kidney function compared to either therapy alone or placebo in obese patients with type 2 diabetes.

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Crossref · 10.1111/dom.14410

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FIGURE 1 Changes in kidney function variables after 16 weeks' treatment with placebo (red, n = 14), exenatide (grey, n = 16), dapagliflozin (light blue, n = 16) and exenatide‐dapagliflozin (dark blue, n = 16). A, Change in urinary albumin:creatinine ratio (UACR; %). B, Change in 24‐hour urinary albumin excretion (%). C, Change in UACR in 37 participants (placebo, n = 10; exenatide, n = 12; dapagliflozin, n = 5; exenatide‐dapagfliflozin, n = 10), using an angiotensin‐converting enzyme inhibitor or angiotensin receptor blocker. D, Change in urinary kidney injury molecule‐1:creatinine ratio (%). E, Change in creatinine‐estimated glomerular filtration rate (eGFRcreat; mL/min/1.73 m2). F, Change in cystatin C‐estimated GFR (eGFRcystC; mL/min/1.73 m2). CI, confidence interval; KIM, kidney injury molecule‐1
FIGURE 1 Changes in kidney function variables after 16 weeks' treatment with placebo (red, n = 14), exenatide (grey, n = 16), dapagliflozin (light blue, n = 16) and exenatide‐dapagliflozin (dark blue, n = 16). A, Change in urinary albumin:creatinine ratio (UACR; %). B, Change in 24‐hour urinary albumin excretion (%). C, Change in UACR in 37 participants (placebo, n = 10; exenatide, n = 12; dapagliflozin, n = 5; exenatide‐dapagfliflozin, n = 10), using an angiotensin‐converting enzyme inhibitor or angiotensin receptor blocker. D, Change in urinary kidney injury molecule‐1:creatinine ratio (%). E, Change in creatinine‐estimated glomerular filtration rate (eGFRcreat; mL/min/1.73 m2). F, Change in cystatin C‐estimated GFR (eGFRcystC; mL/min/1.73 m2). CI, confidence interval; KIM, kidney injury molecule‐1CC BY-NC-ND · PubMed Central

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Research works printed but not linked: 15

  1. 10.1161/CIRCULATIONAHA.116.021887 · DOI · Paper page
  2. 10.2337/dc18-0588 · DOI
  3. 10.1016/S2213-8587(16)30267-4 · DOI
  4. 10.1038/s41598-019-55524-w · DOI
  5. 10.7326/0003-4819-150-9-200905050-00006 · DOI · Paper page
  6. 10.1016/S2213-8587(18)30104-9 · DOI · Paper page
  7. 10.1111/dom.12936 · DOI
  8. 10.1111/dom.12654 · DOI
  9. 10.1056/NEJMoa1515920 · DOI · Paper page
  10. 10.1001/jama.2015.0602 · DOI
  11. 10.1038/nrneph.2017.123 · DOI · Paper page
  12. 10.1038/nrneph.2016.159 · DOI
  13. 10.2215/CJN.11220720 · DOI
  14. 10.1111/dom.12954 · DOI · Paper page
  15. 10.1016/S2213-8587(19)30086-5 · DOI · Paper page

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Metadata

Authors
van Ruiten, C. C., van der Aart‐van der Beek, A. B., IJzerman, R. G., Nieuwdorp, M., Hoogenberg, K., van Raalte, D. H., & Heerspink, H. J. L.
Affiliations
  • Diabetes Centre, Department of Internal Medicine Amsterdam UMC, Location VUMC Amsterdam The Netherlands
  • Clinical Pharmacy and Pharmacology University of Groningen Groningen The Netherlands
  • Department of Internal Medicine Martini Hospital Groningen The Netherlands
ORCID
Venue
Diabetes, Obesity and Metabolism
Publisher
Wiley
Published
2021-05-14
Volume
23
Issue
8
Pages
1851-1858
ISSN
  • 1462-8902
  • 1463-1326
DOI
10.1111/dom.14410
PMC
PMC8360098
Cited by
53
References
11
Language
en
Licence
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)

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