SGLT-2 Inhibition, Metabolomics and Cardiovascular Disease

SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardioprotection

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005136-41-ES

Enrollment

Registered

2018-10-25

Start date

2018-12-12

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes mellitus MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Trade Name: Forxiga 10 mg Pharmaceutical Form: Tablet INN or Proposed INN: Dapaglifozin CAS Number: 461432-26-8 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 18-75. - BMI 27-39.9 kg/m2. - T2DM under treatment with metformin and inadequate metabolic control (defined as HbA1c=6.5% and =7%). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: - Pregnancy (all women of child-bearing age, unless treatment with contraceptive methods, will undergo a pregnancy test) - Intolerance/allergy to dapagliflozin. - Treatment with antidiabetic drug other than metformin. - Impaired kidney function: Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) 2.0 mg / dl or GOT levels three times higher than normal upper limit. - Known HIV infection or active HBV or HCV infection. - Serious underlying diseases, which could affect the patient's ability to participate in the study. - Reduced life expectancy (<12 months) due to the presence of advanced or terminal concomitant diseases.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the metabolomics changes associated with dapagliflozin or placebo after 12 weeks of treatment, both in plasma and urine; Secondary Objective: - Changes in body mass index (BMI) after 12 weeks of treatment with dapagliflozin or placebo. - Changes in insulin resistance (measured by HOMA-IR) after 12 weeks of treatment with dapagliflozin or placebo. - Changes in HbA1c after 12 weeks of treatment with dapagliflozin or placebo. - Changes in the SF-36 questionnaire (quality of life) after 12 weeks of treatment with dapagliflozin or placebo. ;Primary end point(s): Metabolomics changes, both in plasma and urine.;Timepoint(s) of evaluation of this end point: Baseline and after 12 weeks of treatment with dapagliflozin or placebo.	—

Measure

Time frame

Main Objective: To evaluate the metabolomics changes associated with dapagliflozin or placebo after 12 weeks of treatment, both in plasma and urine; Secondary Objective: - Changes in body mass index (BMI) after 12 weeks of treatment with dapagliflozin or placebo. - Changes in insulin resistance (measured by HOMA-IR) after 12 weeks of treatment with dapagliflozin or placebo. - Changes in HbA1c after 12 weeks of treatment with dapagliflozin or placebo. - Changes in the SF-36 questionnaire (quality of life) after 12 weeks of treatment with dapagliflozin or placebo. ;Primary end point(s): Metabolomics changes, both in plasma and urine.;Timepoint(s) of evaluation of this end point: Baseline and after 12 weeks of treatment with dapagliflozin or placebo.

—

Secondary

Measure	Time frame
Secondary end point(s): - BMI changes - Insulin resistance changes (measured as HOMA-IR) - Metabolic control (measured as HbA1c) - Quality of Life (measured as SF-36 questionnaire). ;Timepoint(s) of evaluation of this end point: Baseline and after 12 weeks of treatment with dapagliflozin or placebo.	—

Countries

Spain

Contacts

Public ContactPlataforma de Estudios Clínicos

FIMABIS

estudios.clinicos@fimabis.org

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026