EUCTR2017-003779-75-ES
Active, not recruiting
Phase 1
Randomized clinical trial to assess the impact of treatment with empagliflozine on systemic inflammatory and renal parameters in patients with Diabetes Mellitus type 2 and ischemic heart disease.
ConditionsType 2 Diabetes MellitusTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsJardiance
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Hospital Universitario La Paz
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients diagnosed with type 2 DM with poor metabolic control (glycosylated hemoglobin\> 6\.5%)
- •2\. Patients who have suffered an acute myocardial infarction or who have undergone a coronary revascularization procedure within 30 days prior to the start of the study.
- •3\. Over 18 and under 85
- •4\. Treatment with any hypoglycaemia including insulin.
- •5\. Left ventricular ejection fraction preserved (LVEF\> 40%)
- •6\. Patients who have signed their consent to participate in the study
- •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
Exclusion Criteria
- •1\. Patients with type 1 DM.
- •2\. Previous or current treatment with an SGLT2 inhibitor.
- •3\. Creatinine clearance \<60 ml / min / 1\.73m2\.
Outcomes
Primary Outcomes
Not specified
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