NCT03131232

Brief Summary

In summary, the registry should provide novel insight into potential mechanisms of cardiovascular risk reduction in patients treated with Empagliflozin with an indication of intensified glucose lowering therapy based on their HbA1c level.

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
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

April 13, 2017

Last Update Submit

April 24, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

  • The effect of empagliflozine on glucose metabolism

    HbA1c in %

    6 month

  • The effect of empagliflozine on glucose metabolism

    Body weight in kg

    6 month

  • The effect of empagliflozine on glucose metabolism

    BMI in kg/m²

    6 month

  • The effect of empagliflozine on glucose metabolism

    blood pressure in mmHg

    6 month

  • The effect of empagliflozine on glucose metabolism

    NT-pro BNP in pg/ml

    6 month

Secondary Outcomes (4)

  • Frequency of urinary and urogenital infections

    6 month

  • detection differential regulation of endogenous and exogenous metabolites in addition to circulating proteins by empagliflozin.

    6 month

  • Lipid measurements

    6 month

  • - echocardiographic parameters (if collected) with determination of the systolic and diastolic left ventricular function

    6 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

If possible, all patients of the Department MK1 Uniklinik Aachen who are treated with empagliflozine

You may qualify if:

  • Diabetes mellitus II Patients with whom an empagliflozine treatment is to be initiated from a clinical indication

You may not qualify if:

  • Inability to consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dirk DM Müller Wieland, Scientific Director

    Coordination Center for Clinical Study

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 27, 2017

Study Start

December 10, 2015

Primary Completion

August 1, 2017

Study Completion

December 31, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share