The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function.

Sponsor
AstraZeneca
Study ID
NCT03152084
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    The study consists of a 2-week, open label, dapagliflozin (10mg) treatment period.

Study Details

The purpose of this study is to evaluate how dapagliflozin mechanism of action is impacted by Type 2 Diabetes Mellitus status and kidney function

Key Dates

Start date
Jul 12, 2017
Status verified
May 2021
Primary completion
Mar 20, 2020
Completion
Mar 20, 2020

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    T2DM subjects with an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit.
  • Experimental: Arm 2
    T2DM subjects with an eGFR (CKD-EPI) between \>90 and ≤130 mL/min/1.73m2 for patients aged 59 or younger, between \>85 and ≤130 mL/min/1.73m2 for patients aged 60 to 69, and between \>75 and ≤130 mL/min/1.73m2 for patients aged 70 or older at the Screening Visit.
  • Experimental: Arm 3
    Non-diabetic subjects with an eGFR (CKD-EPI) between ≥25 and ≤50 mL/min/1.73m2 at the Screening Visit.

Primary Outcome Measure

Change in 24-hour Sodium Excretion From Baseline to Start of Treatment [ Time Frame: From baseline (Day -3 to Day -1) to start of treatment (Day 2 to Day 4) ]

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