AstraZeneca today announced the results of DERIVE, a Phase 3 study that evaluated the efficacy and safety of FARXIGA®(dapagliflozin 10 mg), in patients with type 2 diabetes (T2D) with moderate renal impairment (chronic kidney disease [CKD] stage 3A with eGFR of 45-59 mL /min /1 .73m2). The results were presented at the Endocrine Society’s 100th Annual Meeting and Expo (ENDO).
FARXIGA, an SGLT2 inhibitor, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D mellitus.1 FARXIGA is not indicated for weight loss or for the treatment of CKD or hypertension.
The DERIVE trial randomized 321 patients with T2D (hemoglobin A1C [HbA1C] between 7-11%; mean 8.2%) and stage 3A CKD (mean estimated glomerular filtration rate [eGFR] 53 mL/min/1.73m2) from eight countries and treated them with either dapagliflozin 10 mg or placebo over 24 weeks.2 The study met its primary and secondary efficacy endpoints including:
- Dapagliflozin 10 mg significantly decreased mean HbA1C (-0.37%) vs placebo (-0.03%) from baseline to week 24 (difference -0.34%, p < 0.001).
- Dapagliflozin 10 mg significantly reduced mean body weight (-3.17 kg) vs placebo (-1.92 kg) from baseline to week 24 (difference -1.25 kg, p < 0.001).
- Dapagliflozin 10 mg significantly reduced mean fasting plasma glucose (-21.46 mg/dL) vs placebo (-4.87 mg/dL) from baselines to week 24 (difference -16.6 mg/dL, p = 0.001).
- Dapagliflozin 10 mg significantly reduced mean systolic blood pressure (-4.8 mm Hg) vs placebo (-1.7 mm Hg) from baseline to week 24 (difference -3.1 mm Hg, p < 0.05).
The DERIVE trial also provides the following safety information:
- Mean eGFR was decreased at 24 weeks with dapagliflozin (-3.23 mL/min/1.73m2) vs placebo (-0.63 mL/min/1.73m2) (difference [95% CI]: -2.60 mL/min/1.73m2[−5.03 vs −0.16]).
- Overall, adverse events (AEs) occurred in 41.9% of patients with dapagliflozin and 47.8% with placebo. AEs related to study treatment by the investigators were reported in 10.6% of patients with dapagliflozin and 6.2% with placebo. The most frequent AEs related to study treatment included urinary tract infection and pollakiuria.
- No AEs of bone fracture or amputation were reported in the study.
FARXIGA is contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or in patients on dialysis. FARXIGA is not recommended in patients with an eGFR persistently between 30 and <60 mL/min/1.73 m2. The recommended starting dose for FARXIGA is 5 mg.
Jim McDermott, PhD, Vice President, US Medical Affairs, Diabetes at AstraZeneca, said: "We are committed to helping patients with complex and comorbid diseases like T2D and chronic kidney disease, which is demonstrated through the breadth of our research and our unique cardiovascular, renal and metabolic approach. The DERIVE study will help us learn more and provide additional data for FARXIGA in T2D."
DERIVE adds important information to previous dapagliflozin studies in patients with T2D diabetes and moderate renal impairment. AstraZeneca is planning to submit the results of DERIVE to the FDA to add to the breadth of data already contained within the existing FARXIGA Prescribing Information.
According to the Centers for Disease Control and Prevention, 30.3 million people in the US have diabetes, and T2D accounts for 90% to 95% of all diabetes cases.3 T2D is the leading cause of CKD in the US, affecting over 40% of patients, and sustaining control of diabetes can help lower patients risk of developing severe kidney disease.4, 5
Important Safety Information for FARXIGA® (dapagliflozin)
Contraindications
- Prior serious hypersensitivity reaction to FARXIGA
- Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis
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