Dapa

INTRODUCTION

A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD7

An exploratory Phase II/III, randomised, double-blind,  placebo-controlled, 24-week study to evaluate the efficacy, safety and pharmacodynamics of dapagliflozin and dapagliflozin in combination with saxagliptin in patients with Type 2 diabetes, CKD and albuminuria treated with ACEi or ARB.

NAME OF STUDY

delight
patients

~ 460 patients

status

Status:
Active not recruiting

duration

Duration:
July 2015 – April 2018
(34 Months to estimated completion)

STUDY DESIGN

POPULATION

  • Type 2 diabetes, CKD and albuminuria
  • ≥18 years old
  • HbA1c ≥7.0% and ≤11.0%
  • eGFR 25–75 mL/minute/1.73 m2*
  • Micro or macroalbuminuria (UACR 30–3500 mg/g)
  • Treatment with ACEi or ARB
  • BMI 20–45 kg/m2

RANDOMISATION

dapagliflozin study

GOALS

  • PRIMARY ENDPOINT

    • Change in HbA1c
    • Percent change in UACR

  • SECONDARY ENDPOINT

    • Percent change in total bodyweight
    • Change in FPG
    • Proportion of patients who achieve 30% reduction UACR
    • Proportion of patients who achieve HbA1c <7%
    • Change in seated SBP
    • Change in HbA1c

DISCLAIMER

*Dapagliflozin is not recommended for use in patients with eGFR <60 mL/minute/1.73 m2.8 The efficacy of dapagliflozin is dependent on renal function.8
Dapagliflozin is not indicated for the management of weight loss, blood pressure reduction or to reduce albuminuria. Weight loss was a secondary endpoint in clinical trials. Dapagliflozin is not indicated for prevention of CV events. Please consult your local prescribing information for the approved use of dapagliflozin. Saxagliptin is not indicated for the management of weight loss, blood pressure or albuminuria. Please consult your local prescribing information for approved use of saxagliptin.

For full prescribing information, kindly refer to the approved package insert

S4 FORXIGA® 5 mg (tablets) Reg. No. 46/21.2/0214. Each tablet contains the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol. Contains lactose anhydrous.
S4 FORXIGA® 10 mg (tablets) Reg. No. 46/21.2/0215. Each tablet contains the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol. Contains lactose anhydrous.
PHARMACOLOGICAL CLASSIFICATION:A 21.2 Oral hypoglycaemics. INDICATIONS: FORXIGA ® is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as monotherapy or add-on combination therapy. WARNINGS AND PRECAUTIONS: Reports of metabolic acidosis, including ketoacidosis, which were serious life-threatening or fatal, in patients taking FORXIGA ®. Patients who present with signs and symptoms, should discontinue FORXIGA® and the patient should be promptly evaluated and managed accordingly

AstraZeneca Pharmaceuticals (Pty) Ltd. South Africa Reg. No. 1992/005854/07

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Activity ID: ZA-1590. Expiry Date: October 2020
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