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SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease

NCT03919656 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Dapagliflozin 10 mg

Dapagliflozin 10 mg daily in a green, plain, diamond shaped, film coated tablet (orally)

DRUG

Placebo Oral Tablet

Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    lead OTHER

Principal Investigators

  • Jose Carlos Fernandez-Garcia, MD, PhD · Virgen de la Victoria Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-12
Primary Completion
2024-01-12
Completion
2024-05-23

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03919656 on ClinicalTrials.gov