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. - DAPASALT

Study identifier:D1690C00049

ClinicalTrials.gov identifier:NCT03152084

EudraCT identifier:2016-002961-79

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

DAPASALT: An Open Label, Phase IV, Mechanistic, Three-Arm Study to Evaluate the Natriuretic Effect of 2-Week Dapagliflozin treatment in Type 2 Diabetes Mellitus Patients with Either Preserved or Impaired Renal Function and Non-Diabetics with Impaired Renal Function

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 4

Healthy volunteers

No

Study drug

Dapagliflozin

Sex

All

Actual Enrollment

24

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 12 Jul 2017
Primary Completion Date: 20 Mar 2020
Study Completion Date: 20 Mar 2020

Study design

Allocation: Non-randomized
Endpoint Classification: Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 May 2021 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria