NCT03919656CompletedPhase 4
SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease
SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardio- and Nephroprotection
Source: ClinicalTrials.gov · Last updated 15 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 11 Apr 2019
- Start date
- 12 May 2019
- Primary completion date
- 12 Jan 2024
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Diseases
- Type 2 diabetes
- NCT number
- NCT03919656
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 60
- From 12 May 2019 to the primary completion date, 12 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnancy (all women of child-bearing age, unless on treatment with contraceptive methods, will undergo a pregnancy test)
- Treatment with antidiabetic drug other than metformin.
- Reduced life expectancy (\<12 months) due to advanced or terminal concomitant diseases.
- In addition, female patients of child-bearing age will be advised to use contraceptive methods during the study period, given the contraindication of dapagliflozin and metformin during pregnancy as per normal clinical practice.
Other illness
- Intolerance/allergy to dapagliflozin.
- Patients with established cardiovascular disease.
- Previous or current history of cancer of any kind.
- Uncontrolled hypertension (systolic blood pressure≥160 mmHg or diastolic blood pressure≥110 mmHg, despite adequate antihypertensive treatment).
- Known HIV infection or active HBV or HCV infection.
- Other serious underlying diseases, which could affect the patient's ability to participate in the study.
Lab values
- Impaired kidney function: Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 (calculated using the CKD-EPI formula).
- History of liver tumour or acute or chronic liver disease with impaired liver function: total bilirubin levels\> 2.0 mg / dl or GOT/GPT levels three times higher than normal upper limit.
Other
- Breastfeeding
Who the study is looking for
- Age 18-75.
- BMI 27-39.9 kg/m2.
- T2DM on treatment with metformin and inadequate metabolic control (defined as HbA1c≥6.5 -7%).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virgen de la Victoria University Hospital. Endocrinology Department Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.