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The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes (EMPOX)

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ClinicalTrials.gov Identifier: NCT02890745
Recruitment Status : Unknown
Verified December 2016 by Henrik Enghusen Poulsen, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : September 7, 2016
Last Update Posted : December 2, 2016
Sponsor:
Collaborators:
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Information provided by (Responsible Party):
Henrik Enghusen Poulsen, Rigshospitalet, Denmark

Brief Summary:
The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes. The association is examined by comparing the difference in oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and 8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment with placebo. The results will be published in a peer-review journal.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Empagliflozin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EMPOX - A Randomised, Double-blinded, Placebo Controlled Study That Evaluates the Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
Study Start Date : November 2016
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Empagliflozin
One tablet 25 mg empagliflozin every morning for 14 days
Drug: Empagliflozin
Placebo Comparator: Placebo
One tablet placebo every morning for 14 days
Drug: Placebo



Primary Outcome Measures :
  1. Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h) [ Time Frame: Change from baseline after fourteen days of intervention ]
  2. Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h) [ Time Frame: Change from baseline after fourteen days of intervention ]

Secondary Outcome Measures :
  1. Plasma levels of malondialdehyde [ Time Frame: Change from baseline after fourteen days of intervention ]
  2. Plasma levels of iron, ferritin, transferrin and transferrin saturation [ Time Frame: Measured at baseline and after intervention ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • HbA1c: 6.5-9.0%
  • Capable of understanding oral- and written information

Exclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) < 60 mL/hour/1.73 m2
  • Currently receiving insulin treatment
  • Coronary artery bypass grafting, percutaneous coronary intervention, acute coronary syndrome, stroke, lung embolism, deep vein thrombosis, or transitory cerebral ischemia within 6 months
  • Genital infection within 14 days
  • Plasma alanine aminotransferase ≥3 times upper normal limit
  • Treatment with sodium glucose cotransporter (SGLT) -2 inhibitor within 2 months
  • Hyperglycaemic symptoms
  • Psychiatric disorder
  • Intolerance to empagliflozin or other agents relevant to study
  • Non-compliant

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): NCT02890745


Contacts
Contact: Henrik Enghusen Poulsen, Professor, DMSc +45 3545 7695 hepo@rh.dk

Locations
Denmark
Center for Diabetes Research, Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Jørgen Rungby, DMSc    +45 3977 7539    jr@biomed.au.dk   
Principal Investigator: Jørgen Rungby, Professor, DMSc         
Sponsors and Collaborators
Henrik Enghusen Poulsen
University Hospital, Gentofte, Copenhagen
University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henrik Enghusen Poulsen, Professor, DMSc, chief physician, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02890745     History of Changes
Other Study ID Numbers: 2016-100
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016

Keywords provided by Henrik Enghusen Poulsen, Rigshospitalet, Denmark:
Empagliflozin
Oxidative stress
Oxidative nucleic acid modifications
8-oxo-7,8-dihydro-2'-deoxyguanosine
8-oxo-7,8-dihydroguanosine

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