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Trial record 33 of 187 for:    BI10773

Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes (EMPA)

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ClinicalTrials.gov Identifier: NCT03132181
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:

SGLT2 inhibitors are a novel class of glucose lowering drugs that act in the kidney by inhibiting SGLT2-mediated glucose reabsorption in the proximal tubule. The resulting increase in urinary glucose excretion leads to a reduction in plasma glucose levels. This is accompanied by reduction of total body weight due to urinary energy loss. In addition, glucose dependent osmotic diuresis contributes to blood pressure lowering effects of SGLT2 inhibition.

Aim of the trial is to assess hemodynamic changes by empagliflozin, identify new empagliflozin dependent metabolic regulators and evaluate empagliflozin dependent effects on cardiac function.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 (T2DM) Drug: Empagliflozin Other: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Empagliofizin
Patients will receive empagliflozin 10 mg qd for a period of 3 months.
Drug: Empagliflozin
Patient will be treaded according to standard care but additionally take one tablet Empagliflozin per day
Other Name: Jardiance

Placebo Comparator: Placebo
Patients of the placebo arm will receive placebo tablets qd for a period of 3 months.
Other: Placebo
Patient will be treaded according to standard care but additionally take one tablet placebo per day




Primary Outcome Measures :
  1. Mode of action [ Time Frame: 3 months ]
    vascular resistance (dyn*s/cm^5)

  2. Mode of action [ Time Frame: 3 months ]
    cardiac output (l/min)


Secondary Outcome Measures :
  1. Hemodynamics [ Time Frame: 3 months ]
    Stroke volume (ml/beat)

  2. Hemodynamics [ Time Frame: 3 months ]
    stroke volume variation (%)

  3. Energie expenditure [ Time Frame: 3 months ]
    resting energy expenditure (calories/24h)

  4. Cardio cascular [ Time Frame: 3 months ]
    blood pressure (mmHg)

  5. Urine [ Time Frame: 3 months ]
    24 h sodium excretion (mmol/day)

  6. Body weight [ Time Frame: 3 months ]
    body weight (kg)

  7. Cardio vascular [ Time Frame: 3 months ]
    heart rate (bpm)

  8. Blood [ Time Frame: 3 months ]
    NT-proBNP (ng/l)

  9. Blood [ Time Frame: 3 months ]
    cystatin C(mg/dl)

  10. Blood [ Time Frame: 3 months ]
    serum levels of Glucose (mg/dl)

  11. Blood [ Time Frame: 3 months ]
    HbA1c (%)

  12. Metabolism [ Time Frame: 3 months ]
    total-ketone bodies (mmol/l)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes
  2. Serum levels of HbA1c ≥ 6.5 %, despite treatment with diet and glucose lowering agents, which should include metformin (unless intolerance or contraindication to metformin exists)
  3. Age ≥ 18 years
  4. Participants of child-bearing age should use adequate contraception
  5. Written informed consent prior to study participation

Exclusion Criteria:

  1. Type 1 diabetes
  2. Systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 90 mmHg
  3. Age ≥ 75 years
  4. Pregnancy or lactating females
  5. Urinary tract infections or significant formation of residual urine in medical history
  6. Renal impairment (GFR < 30 ml/min/1.73 m2)
  7. Liver disease (serum levels of AST, ALT or AP more than three times the upper limit of normal)
  8. Uncontrolled thyroid disease
  9. Endocrinopathies like Graves' disease, acromegaly, Cushing's disease
  10. Hypertensive retinopathy or encephalopathy
  11. Acute coronary syndrome, stroke or transient ischemic attack in last 6 weeks prior to randomization
  12. The subject is mentally or legally incapacitated
  13. The subject received an investigational drug within 30 days prior to inclusion into this study
  14. Patients with newly diagnosed diabetes, who have not been subjected to diet and glucose lowering drug treatment.
  15. Patients with particular risk for ketoacidosis (alcohol abuse, pancreatitis, pancreatic insulin deficiency from any cause, caloric restriction etc.) or ketoacidosis in the past
  16. Frequent hypoglycaemic events (in the opinion of the investigator)
  17. Patients in whom study participation is not deemed appropriate under consideration of clinical wellbeing by the principal investigator
  18. Intolerance to Empagliflozin and excipients in Empagliflozin or rather placebo
  19. Hypotension in the past (systolic blood pressure < 90 mmHg) in patients receiving treatment with blood lowering drugs
  20. Signs of exsiccosis
  21. Previous treatment with Empagliflozin in the past
  22. Critically ill patients (in the opinion of the investigator)

Information from the National Library of Medicine

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): NCT03132181


Contacts
Contact: Michael Lehrke, PD Dr. med. +49 241 80 85152 mlehrke@ukaachen.de

Locations
Germany
Department of Internal Medicine I RWTH Aachen University Hospital Recruiting
Aachen, NRW, Germany, 52074
Contact: Michael Lehrke, PD Dr. med.    +49 241 80 85152    mlehrke@ukaachen.de   
Principal Investigator: Michael Lehrke, PD Dr. med.         
Sub-Investigator: Nikolaus Marx, Univ.-Prof. Dr. med.         
Sponsors and Collaborators
RWTH Aachen University
Boehringer Ingelheim
Investigators
Principal Investigator: Nikolaus Marx, Univ.-Prof. Dr. med. University Hospital, Aachen

Publications:

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03132181     History of Changes
Other Study ID Numbers: 15-124
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
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

Keywords provided by RWTH Aachen University:
Empagliflozin
Diabetes
Systemic vascular resistance
Cardiac output
Blood pressure

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs