NCT02918591

Brief Summary

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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

September 27, 2016

Last Update Submit

October 10, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change of Soluble Klotho

    The blood levels of soluble Klotho will be quantified at baseline after one month and after two month of treatments with Empagliflozine

    up to 2 months

Secondary Outcomes (6)

  • Change of Fibroblast growth factor 23 (FGF23)

    up to 2 months

  • Change of 1,25 (OH)Vit D

    up to 2 months

  • Change of Parathyroid Hormone (PTH)

    up to 2 months

  • Change of Glomerular Filtration Rate (eGFR)

    up to 2 months

  • Change of Blood Chemistry

    up to 2 months

  • +1 more secondary outcomes

Study Arms (1)

Empagliflozine

EXPERIMENTAL

All type 2 diabetic participant will be treated during 2 month with Empagliflozine 10 to 25 mg daily during 2 month.

Drug: Empagliflozine

Interventions

EmpagliflozineDRUG

All 6type 2 diabetic participant will receive treatment with Empagliflozine during 2 month

Also known as: EMP
Empagliflozine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Julio Wainstein, MD

CONTACT

972506296940vainstein@wmc.gov.il

Daniela Jakubowicz

CONTACT

508105552daniela.jak@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 29, 2016

Study Start

November 1, 2017

Primary Completion

March 1, 2018

Study Completion

December 1, 2018

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share