Effect of Dapagliflozin on Microvascular and Macrovascular Circulation and Total Body Sodium Content

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT02383238
Phase
PHASE3
Status
Completed

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    10 mg, oral for 6 weeks
  • Placebo — DRUG
    oral for 6 weeks

Study Details

Dapagliflozin leads to improved vascular function in the micro- and macrocirculation by action on various cardiovascular risk factors, in particular by effectively controlling hyperglycemia, arterial hypertension and reducing whole sodium content amongst others.

Key Dates

Start date
Mar 31, 2014
Status verified
May 2018
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    Dapagliflozin, 10 mg/day, oral administration, 6 weeks
  • Placebo Comparator: Placebo
    Placebo, oral administration, 6 weeks

Primary Outcome Measure

Microcirculation [ Time Frame: 6 weeks ]

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