SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease

Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study ID
NCT03919656
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin 10 mg — DRUG
    Dapagliflozin 10 mg daily in a green, plain, diamond shaped, film coated tablet (orally)
  • Placebo Oral Tablet — DRUG
    Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient

Study Details

This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.

Key Dates

Start date
May 12, 2019
Status verified
Jun 2025
Primary completion
Jan 12, 2024
Completion
May 23, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10 mg daily (orally)
  • Placebo Comparator: Placebo
    Matching placebo for dapagliflozin daily (orally). Does not contain active ingredient

Primary Outcome Measure

Metabolomics changes in blood [ Time Frame: From baseline to week 12 ]

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