Cardiovascular Effects of Empagliflozine (EMP)
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ClinicalTrials.gov Identifier: NCT02918591 |
Recruitment Status : Unknown
Verified October 2017 by Daniela Jakubowicz, Tel Aviv University.
Recruitment status was: Not yet recruiting
First Posted : September 29, 2016
Last Update Posted : October 11, 2017
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It has been shown that in patients with type 2 diabetes (T2D) at high risk for cardiovascular disease (CVD) who received Empagliflozine as compared with placebo had a lower rate of death from cardiovascular causes, non-fatal MI, or non-fatal strokes as well as death from any cause and hospitalization for heart failure.
This lower incidence of cardiovascular disease in individuals treated with selective inhibitor of renal sodium-glucose co-transporters (SGLTs) has been associated with reduction of blood levels of fibroblast growth factor 23 (FGF23) and with increase of blood levels of Klotho.
Therefore we will investigate the blood levels of fibroblast growth factor 23 (FGF23) and of Klotho in type 2 diabetic patients treated with Empagliflozine The investigators anticipate that patients treated with Empagliflozine will have decreased levels of FGF23 and increased levels of Klotho which would provide a good explanation for the beneficial cardiovascular effects of selective inhibitors of renal sodium-glucose co-transporters (SGLTs)
Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes | Drug: Empagliflozine | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Physiological and Cardiovascular Effects of Empagliflozine in Type 2 Diabetes |
Estimated Study Start Date : | November 2017 |
Estimated Primary Completion Date : | March 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
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Experimental: Empagliflozine
All type 2 diabetic participant will be treated during 2 month with Empagliflozine 10 to 25 mg daily during 2 month.
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Drug: Empagliflozine
All 6type 2 diabetic participant will receive treatment with Empagliflozine during 2 month
Other Name: EMP |
- Change of Soluble Klotho [ Time Frame: up to 2 months ]The blood levels of soluble Klotho will be quantified at baseline after one month and after two month of treatments with Empagliflozine
- Change of Fibroblast growth factor 23 (FGF23) [ Time Frame: up to 2 months ]The blood levels of FGF23 will be quantified at baseline after one month and after two month of treatment with Empagliflozine
- Change of 1,25 (OH)Vit D [ Time Frame: up to 2 months ]The blood levels of 1,25 (OH)Vit D will be quantified at baseline after one month and after two month of treatment with Empagliflozine
- Change of Parathyroid Hormone (PTH) [ Time Frame: up to 2 months ]The blood levels of PTH will be quantified at baseline after one month and after two month of treatment with Empagliflozine
- Change of Glomerular Filtration Rate (eGFR) [ Time Frame: up to 2 months ]The levels of eGFR will be quantified at baseline after one month and after two month of treatment with Empagliflozine
- Change of Blood Chemistry [ Time Frame: up to 2 months ]The blood chemistry will be quantified at baseline after one month and after two month of treatment with Empagliflozine
- Change of HbA1c [ Time Frame: up to 2 months ]HbA1c will be quantified at baseline after one month and after two month of treatment with Empagliflozine

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 2 Diabetes
- HbA1C:7.5-10.
- Age>18 years-80 years
- Cardiovascular risk factor: Ischemic heart disease (IHD)
- Status Post Myocardial Infarct (SPMI),
- Angina Pectoris (AP), stable, unstable AP, Peripheral vascular disease (PVD),
- Cerebro vascular accident (CVA), all > 6 month
- Chronic renal failure (CRF),
- e-GFR > 50 ml/min
- Patients will be required to be on stable glucose-lowering therapy for at least 12 weeks before entering the study.
Exclusion Criteria:
- Age<18 years
- Pregnanacy,breast-feeding.
- eGFR < 45mg/dl
- Type1 Diabetes
- Active urogenital infection , or an infection in the last 6 months.
- Recurrent UTI or genital infections.
- SGLT2 treatment.
- History of ketoacidosis.
- Pulmonary embolism/DVT during the last year.
- Malignancy active, (during the last 10 years).
- Steroid use.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918591
Contact: Julio Wainstein, MD | 972506296940 | vainstein@wmc.gov.il | |
Contact: Daniela Jakubowicz | 508105552 | daniela.jak@gmail.com |
Responsible Party: | Daniela Jakubowicz, Professor, Tel Aviv University |
ClinicalTrials.gov Identifier: | NCT02918591 |
Other Study ID Numbers: |
0049-16 WOMC |
First Posted: | September 29, 2016 Key Record Dates |
Last Update Posted: | October 11, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |