Kidney Week

Abstract: TH-PO1156

Effect of Adding Dapagliflozin as an Adjunct to Insulin on Urinary Albumin-to-Creatinine Ratio over 52 Weeks in Adults with Type 1 Diabetes

Session Information

• Late-Breaking Clinical Trials Posters
  October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• No subcategory defined

Authors

• Edelman, Steven, University of California, San Diego, California, United States

Steven Edelman,

• Jendle, Johan, Orebro University, Örebro, Sweden

Johan Jendle,

• Dandona, Paresh, State University of New York at Buffalo, Buffalo, New York, United States

Paresh Dandona,

• Mathieu, Chantal, KULeuven, Leuven, Belgium

Chantal Mathieu,

• Tschoepe, Diethelm, Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

Diethelm Tschoepe,

• Thorén, Fredrik Allan viktor, AstraZeneca, Gothenburg, Sweden

Fredrik Allan viktor Thorén,

• Scheerer, Markus Florian, AstraZeneca, Gothenburg, Sweden

Markus Florian Scheerer,

• Xu, John, AstraZeneca, Gothenburg, Sweden

John Xu,

• Langkilde, Anna Maria, AstraZeneca, Gothenburg, Sweden

Anna Maria Langkilde,

Group or Team Name

• DEPICT-1 and -2 Investigators

Background

DEPICT-1 and DEPICT-2 studies, where dapagliflozin (DAPA) was added as adjunct to insulin in adults with inadequately controlled type 1 diabetes (T1D) (glycated hemoglobin: 7.5%–10.5%), reported improvements in glycemic control and weight, and was well tolerated.

Methods

In this pooled post hoc analysis of the DEPICT-1 and -2 studies, we evaluated the effect of dapagliflozin on Urinary Albumin to Creatinine Ratio (UACR) in individuals with T1D with baseline albuminuria.

Results

In total, 548 individuals treated with DAPA 5 mg, 565 with DAPA 10 mg, and 532 with placebo had UACR recorded at baseline. Albuminuria at baseline was found in 80, 84, and 87 individuals in the DAPA 5 mg, 10 mg, and placebo arms, respectively. Of these 251 individuals, baseline renal function measured as estimated glomerular filtration rate (eGFR) was normal in 93 individuals (eGFR ≥90 mL/min/1.73 m²), mildly impaired in 131 individuals (eGFR ≥60 or <90 mL/min/1.73 m²), and moderately impaired in 27 individuals (eGFR <60 mL/min/1.73 m²). Changes in eGFR appeared similar across the treatment arms (data not shown). However, treatment with DAPA resulted in a dose-dependent reduction in UACR at weeks 12, 18, 24, and 52 (Figure). The difference in UACR between DAPA 10 mg vs placebo was significant from weeks 18 to 52. At week 52, the differences in UACR between DAPA 10 mg and placebo and DAPA 5 mg and placebo were −31.12% (95% CI: −49.94, −5.22) and −13.30 (95% CI: −37.24, 19.79), respectively.

Conclusion

Treatment with DAPA appears to provide a dose-dependent benefit in reducing UACR, suggesting renoprotective effects in individuals with T1D with baseline albuminuria.

Funding

• Commercial Support – AstraZeneca, Gaithersburg, MD, USA.