Dapagliflozin Effect on Erythropoiesis and Physical Fitness

Sponsor
University Hospital Tuebingen
Study ID
NCT03423355
Phase
PHASE4
Status
Withdrawn

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Dapagliflozin effect on erythropoiesis and physical fitness in patients with type 2 diabetes - a randomized, partly double-blinded, controlled, three armed, parallel group, exploratory study

Key Dates

First listed
Feb 6, 2018
Start date
Sep 30, 2021
Status verified
Jul 2021
Primary completion
Mar 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin (Forxiga®)
    Treatment with the SGLT2 inhibitor dapagliflozin 10 mg once daily for 28 days.
  • Placebo Comparator: Placebo matching Dapagliflozin
    Treatment with the Dapagliflozin matching placebo once daily for 28 days.
  • Other: Hydrochlorothiazide
    Treatment with the Hydrochlorothiazide 25 mg once daily for 28 days

Primary Outcome Measure

Change in blood EPO levels [ Time Frame: 2 weeks of treatment ]

Related Studies